Tablet excipients slideshare

The tablets of MF3 batch showed the minimum floating lag time and The EDQM is renewing its call for expressions of interest to join the European Pharmacopoeia (Ph. Maize starch or lactose, for example, are used in tablets, while water-oil emulsions are used in ointments. The drug is dispersed in saliva and swallowed with little or no water. The certificate provides independent validation that ACG ACPL maintains excipient Good Manufacturing Practices and complies with current European Union regulation and US FDA regulation. A formalized process that includes public input on future deletions Pharmaceutical excipients are any substance other than the active drug or prodrug which has been appropriately evaluated for safety and is included in a drug delivery system to either : 1. BY: KOMAL HALEEM PHARM-D TABLET TYPES AND EXCIPIENTS 2. Tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. chemical (often the API, and sometimes the excipients) contained in the dosage form being tested. 1 Aug 2016 Beyond the dosage form necessities, excipients particularly in the case of . Volatility of the plasticizer : Aqueous coating generally need higher drying capacity during the coating cycle due to less volatility of water, For this you should know the single tablet weight( API+ Excipients) Take 20 tablets and grind to powder. Function of fillers: Fillers add volume and/or mass to a drug substance, thereby facilitating precise metering and handling thereof in the preparation of dosage forms . Binders ensure  27 Oct 2016 Chemistry, physical properties and uses of following excipients: Acidifying agents , So we have to exclude it in the chewable tablet. The process may improve the dissolution rate of poorly soluble drugs by imparting hydrophilic properties to the surface of the granules. Mucoadhesive polymers as drug delivery vehicles. Tablet Excipients: Excipients are substance other that active ingredient in formulation of tablet. speed tablet presses can produce up to 12,000 tablets/min, and the average tablet press speed is 3000 tablets/min. Three excipients, chitin, dibasic calcium phosphate and corn starch play different roles in tablet formulation. of In fact , a tablet represents a mixture of one or more active ingredients with a number of “inactive” ingredients or excipients. 1. 5 mg, 5 mg, 7. . 3. Buccal and Sublingual tablets: •Small, flat tablets, intended to be held between cheek and teeth or in the cheek pouch (buccal tablets) or beneath the tongue (sublingual tablets). Tablets •WHO guidelines on good manufacturing practices for heating, ventilation and air‐ conditioning systems for non‐sterile Featuring mechatronis and confirming to the requirement of cGMP. Suppositories should melt at just below body temperature (37 C), which allows for erosion of the dosage form and release of the API. pharmaceutical active substances and excipients, were approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in 1992, 1997, and therafter. Tablets may be formulated to offer rapid drug release or controlled drug release, the latter reducing the number of daily doses required (and in so doing increasing patient compliance). Tablets are small, flat, and oval, with a diameter of approximately 5–8 mm. DILUENTS  Diluents increase the volume to a formulation to prepare tablets of the desired size. Compare and contrast the advantages/disadvantages of various drug dosage forms 3. D. Good stomach and intestinal tolerance - effervescent tablet dissolve fully in a buffered solution. 4. List reasons for the incorporation of drugs into various dosage forms 2. Inactive ingredients or excipients can make up most of a medicine’s volume and serve as carriers for the active compound. Conventional and chewable tablets are used to administer drugs to dogs and cats, whereas modified-release boluses are administered to cattle, sheep, and goats. Differential Scanning Calorimeter (DSC) study shows that drug and other excipients are compatible with each other. Depend on intended use; they are subcategorised in different groups. DIRECTLY COMPRESSIBLE VEHICLE Introduction The method consist of compressing tablets directly from powdered material without modifying the physical nature of the material. g. This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment. A healthier world needs a strong foundation – one that establishes quality, sets the bar for scientific rigor and technological progress, and epitomizes collaboration between industry, nonprofits, government and academia. In infants and children the dosage is preferably calculated by body weight. Insufflations – finely divided powders introduced into the body cavities. txt) or view presentation slides online. 316 with acrylic cover. Particle properties of active drug substances or excipients play an important role in the dosage form fabrication and performance. Roquette has developed a versatile range of standard disintegration excipients. It manufacturing and drug release rate from the dosage form is controlled mainly by the The success of the compaction process depends not only on the physico-technical properties of drugs and excipients, but also on the instrument settings with respect to rate and magnitude of force transfer. Box 9. Although excipients are the non-active ingredients, they are essential in the successful production of acceptable dosage forms such as tablets. Tablets remain the most popular dosage form. It is possible that a person may have a reaction to an excipient when switching between innovator and generic (or vice-versa), or from one generic to another, but such 2. 11. Disintigrants: Disintegrants are substances or mixture of substances added to the drug formulations, which facilitate dispersion or breakup of tablets and contents of capsules into smaller particles for quick dissolution when it comes in contact with water in the GIT. tumblr. Both tablet and capsule required lubricants in their formulation to reduce friction between the powder and metal surface during manufacture. com • Standard compressed tablets can take 30 minutes or longer to dissolve • Compressed tablets require significant excipients, binders and non-nutritive … Suppository base excipients are used in the manufacture of suppositories (for rectal administration) and pessaries (for vaginal administration). anticancer: injection: v01: baxmune tablets 500 mg. 3 Restricted part of DMF 32R43. Orally disintegrating tablets (ODT). (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. 2. Theyarenotcompletelyre-moved during processing but should be removed to the extent that is possible and reasonable. protect, support or enhance stability, bioavailability or patient acceptability, or. Tablet Coating Basics - After making a good tablet, you must often coat it. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the private sector (pharmaceutical or chemical industries), academia, research organisations and drug substances or excipients, or in the prepara-tionofdrugproducts. Sucrose is the standard against which all sweeteners, both natural and artificial, are measured. Solid-State Properties: Drugs and excipients used where, V0 is the volume at zero porosity. , excipients). 1 3 PHARMACEUTICAL FORM Tablet White circular with break line on one face 4 CLINICAL PARTICULARS 4. 1 Continued 1 Heat a 200mL beaker of water to 37◦Cona magnetic stirring unit set at about 50 rpm. The compatibility of drug with the physical mixture containing Drug, polymer and tablet were evaluated by FT-IR. Excipient (pharmacologically inactive substance) Medically reviewed by Drugs. These results were attributed to the formation of an amorphous state of the drug in the porous lyophilized matrix. R. Why Our Products Are Superior Standard compressed - Superior Source Vitamins. 4 They are usually filled into a capsule, occasionally compressed into larger tablets, or sometimes placed in sachets for easy administration. the starting material of the drug substance, reagents, solvents, purification steps, excipients, drug product manufacturing processes, packaging, and storage of the end product. However excipients affect properties of tablets. Some tablets are swallowed whole or after being chewed, some are dissolved or dispersed in water before administration and some are retained in the mouth where the active ingredient is liberated. Common excipients used in tablets The list of purposes for which excipients are used, as defined in international pharmacopoeias, is extremely long. Most pharmaceutical tablet formulations require the addition of a  The binding excipient can be used dry for direct compression processes, or in Disintegrating agents accelerate the swelling or disintegration of a tablet once it  Co-processing is the way that new excipients coming to the market without undergoing . As soon as the tablet is ejected out it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. Along with these drug excipients interaction, In-vitro dissolution studies and stability studies also performed. the tablet. Tablets are compressed directly from powder blends of the active ingredient (such as chloride, chlorates, bromide, ammonium chloride etc) and suitable excipients. Stability study of Thus, buccal adhesive tablet of repaglinide could be. Machine The defects related to Tableting Process are as follows: i) CAPPING: It is partial or complete separation of the top or bottom of tablet due air-entrapment in the granular material. In tablet manufacture, glidants are usually added just prior to compression. A. study was to formulate Effervescent tablet with sufficient mechanical integrity and to achieve faster disintegration in the water. During preparation dyes are not properly mixed and not selected ideally or any incompatibility will tends to enhance appearance of color on tablet surface. Excipients and equipments choices will be significantly affected should solid dosage form technologies  for developing high functionality excipients that are suited to modern tablet The future scope determines that coprocessed excipients are the rising need of  The development of immediate release tablets also provides an opportunity for a line extension in . External Preparations 2. com. in most of the cases presence of plasticizer improves the gloss level in the finished product (depending on the quality and concentration of the plasticizer). This presentation describes the tablet types and excipients used in tablet manufacturing. ) Indian GMP, SCHEDULE M WHO GMP •Part‐II: Requirements of Plant & Equipment 1. The tablet coating have number of advantages like masking odor, taste, color of the drug, providing physical and chemical protection to drug, Protecting drug from the gastric environment. In addition to the active ingredient(s), a series of excipients is normally included in a tablet; their role is to ensure that the tableting operation can run satisfactorily and that tablets of specified quality are prepared. Some very common diluents in tablets include lactose and their  1 Sep 2010 Introduction Definition: Tablet is defined as a compressed unit solid dosage form containing medicaments with or without excipients. 19. However, - Superior Source Vitamins tumblr. Prior granulation to have a uniform drug/excipients 。 13 Jun 2017 In this work the effect of excipient type and properties, blending technique of excipients is ideal in such formulations; the overall weight of tablets is . Currently we are bringing forth “23 rd International Conference and Exhibition on Pharmaceutical Formulations” (Formulation 2020) scheduled to be held during July 27-28, 2020 at Zurich, Switerzland. TABLET EXCIPIENTS 3. thumbnail. sessment for excipients be implemented? It is the aim of this GMP Education Course to give an-swers to these and many other important questions relat-ing to the testing of APIs and excipients and to serve as a forum for an intensive experience exchange. Pills have now been almost completely replaced by capsules and tablets. Tablet discharge chute is made S. Release from these tablets takes place by a combination of physical phenomena. Oral Liquid Preparations 3. Net. AbstractThe equilibrium moisture content (EMC) was determined for thirty pharmaceutical excipients. 25 Feb 2015 Superdisintegrants are first choice of excipients which are extensively used for the formulation development of the immediate release tablets as . Comparison of Guidelines of Indian GMP with WHO GMP Specific Requirements (Contd. By leveraging the tablet coating expertise of Colorcon, a world leader in the manufacture and development of specialized film coatings, and ARmark's customized microtag authentication technology, the two companies collaborated to enable greater security by authenticating solid oral dose pharmaceuticals. Understanding Oral Solid Dose Form (OSD) Manufacturing The Process/Equipment and Technology Presented by: Dave DiProspero Senior Pharmaceutical Specialist The compatibility of the drug substance with excipients listed in 3. This form of capsule holds dry ingredients in powder form. Hypromellose. Triturations –dilutions of potent powdered drugs prepared by intimately mixing them with a suitable diluent in 1:10 dilutions ORAL SOLID DOSAGE FORMS TABLET – solid dosage form containing drug substances with or without suitable diluents and prepared either by compression or molding methods. Equipment - CustomPart. Oral IR tablet: 2. Key words: USFDA, Inspection, tablet. tablet but tackiness of the tablet and reduction of tablet strength are drawbacks of fluid lubricants. In dry granulation process, API and excipients are subjected to roller compactor where they are converted to slugs. pdf), Text File (. View Full Size|Favorite Figure|Download Slide (. Concepts of Buccal Drug Delivery System. net) Galenic formulation for clinical studies. The word formulation is often used in a way that includes dosage form About 100 mg of sodium valproate working standard was weighed accurately in 100 ml volumetric flask and mobile phase was added, sonicated to dissolve and diluted to the mark to obtain a concentration of 1 mg/ml. These data are to be included in the forth-coming publication of the Handbook of Pharmaceutical E Buccal Tablets . • IMPART WEIGHT, ACCURACY, & VOLUME • IMPROVE SOLUBILITY • INCREASE STABILITY • ENHANCE BIOAVAILABILITY • MODIFY DRUG RELEASE • ASSIST PRODUCT IDENTIFICATION • INCREASE PATIENT ACCEPTABILITY • FACILITATE DOSAGE FORM DESIGN These are the substances added in the Fillers: Fillers typically also fill out the size of a tablet or capsule, making it practical to produce and convenient for the consumer to use. 2 Excipients The excipients chosen, their concentration, and the characteristics that can influence Each tablet contains Aspirin 300mg. 3 Excipients [7, 8] “Pharmaceutical excipients are substance other than pharmacologically active drug or prodrug in finished dosage form as to impart specific qualities to them. com - id: 510332-NjA1O 32A33. Introduction: Tablet uniformity is important and is used to make sure that every tablet contains the amount of drug substances intended with only little variation among tablets within a batch. However, the manufacturing process involves some critical steps that need to be addressed carefully during formulation and factory design. MAHAJAN M. As the density of the tablet falls below 1, the tablet becomes buoyant. 7% w/w for Pearlitol 400 DC and Pearlitol 500 DC; magnesium stearate 1% w/w for Pearlitol 300 DC. Pharmaceutical Excipients are substances other than the active medicament (s) which are included in the manufacturing process or are contained in the finished pharmaceutical product dosage form. Dr. Agrawal Principal Delhi Institute of Pharmaceutical Science and Research Sector – 3, Pushp Vihar New Delhi (24-07-2007) CONTENTS Introduction Raw material for Capsules Hard Capsules Each tablet contains 500mg paracetamol. The roles of excipients are to ensure tabletting operation satisfactory and ensure that tablets of specified quality are prepared. Lubricants are often hydrophobic in nature; Magnesium stearate is commonly included as a lubricant during tablet compaction and capsule filling operation. dosage forms; Excipients play a key role in the development in emerging dosage forms but attention to quality is crucial. However, there are particular issues that arise in formulating and developing oral liquid dosages. Article history: . MICROBIOLOGICAL QUALITY OF NON-STERILE PHARMACEUTICAL Tablet types and Excipients 1. The state forms. 14 Mar 2014 Basics of pharmaceutical excipients used in formulations. 0-3. For this you should know the single tablet weight( API+ Excipients) Take 20 tablets and grind to powder. Corn>rice>arrowroot>potato.  Studies of starch on dissolution rate of salicylic acid tablet by dry double compression process shows three times increase in dissolution rate when the starch content increase from the 5 – 20 %. Pharmaceutical powder technology also deals with areas of surface engineering usually explored through the applications of surface chemistry and surface morphology. The drug and  Disintegrants and superdisintegrants excipients for capsules and tablets - Roquette developed a versatile range of standard disintegration excipients facilitating  Orodispersible tablets are gaining importance among novel oral . to 13. Pessaries: A tablet is usually a compressed preparation that contains: 5-10% of the drug (active substance); 80% of fillers, disintegrants, lubricants, glidants, and binders; and; 10% of compounds which ensure easy disintegration, disaggregation, and dissolution of the tablet in the stomach or the intestine. Leaching of container ingredients into the drug. aid processing of the system during manufacture, or. 1,2 vi) Tablet compression Two main dry granulation processes Slugging process Granulation by slugging is the process of compressing dry powder of tablet formulation with tablet press having die cavity large enough in diameter to fill quickly. A glidant will only work at a certain range of concentrations. Typical solvents include water, ethanol and isopropanol and methylene chloride either alone or in combination. Static charges may develop on the drug particles or excipients  Quality control tests for solid dosage form (tablets. Water diffuses into the tablet, swells the polymer The prepared tablet formulations were evaluated for various parameters like weight variation, hardness, friability, disintegration time, and drug content. Tablet Compression Machine Tablets are made by compressing a formulation containing a drug or drugs with excipients on stamping machine called presses. The disintegrants have the major function to oppose the efficiency of the tablet binder and the physical forces that act under compression to form the tablet. Changes in the physical properties, such as density, viscosity, particle size distribution, and crystal type and modification, of the active ingredients or excipients may affect the mechanical properties of the material; as a consequence, they may adversely affect the process or the product. Hard gelatin capsules, unlike the soft form, are made of two parts, the body and the cap, each of a different colour. With oscillating type, a diiferent order observed. tablet technology has undergone great improvement. Pellets are prepared using different technologies such as layering of the drug solution, suspension or powder on the inactive cores, extrusion/spheronization, and agglomeration in rotogranulators or rotoprocessors, compression, tablet made of widely used, safe, water-soluble excipients showed much better solubility and much faster dissolution when compared to the plain drug or the PM. Excipients. INTRODUCTION A tablet is a compressed solid unit dosage form containing medicaments with or without excipients. Many in the industry now recognize that excipients have an absolutely fundamental role. Co-processed Excipients Definition: “ two or more by an appropriate process” Aim: processed Excipients Formation of excipients with compared to the simple physical mixtures of their components To obtain a product with related to the ratio of its functionality / price. GUIDANCE DOCUMENT. & Capsules). , contain identical amounts of the same active drug ingredient in the same dosage form and route of administration and meet compendial or These are free flowing, dry conglomerates of particles ranging from 1 to 5 mm in diameter. Selection of appropriate formulation excipients and manufacturing technology can obtain the design feature of fast disintegrating tablet. The coating can have several functions. In addition, fines do not compress well and can contribute to capping and lamination, which are common tablet defects. Target Group This Education Course is directed at all those employees Pills have now been almost completely replaced by capsules and tablets. Binders Binders act as an adhesive to bind together powders, granules and tablets to result in the necessary mechanical strength: As a dry powder with other excipients in dry granulation (roller compaction, slugging) or as an extra-granular excipient in a wet granulation tablet formulation. Discernment of degradation products in formulations that are related to drug substances versus those that are related to non–drug substances (e. Binders: Binders hold the ingredients in a tablet together . Pharm, VU 4 Pharmaceutical Excipients Binders Binders hold the ingredients in a tablet together. They are intended for oral administration. Tablet dosage form has number of potential advantages over the other solid dosage forms as well as liquid dosage forms such as: Advantages. Definition. Most commonly investigated dosage form for Buccal drug. The milling process requires a milling machine, workpiece . They may be plain or coated. 2-0. Chapter 9 • Quality control of suppositories 141. On the other hand, compressing the lower-tray granulations, which may contain too much moisture, can cause granules to stick to the tablet-press tooling, another situation that produces defective tablets. In case of more potent, low-dose drugs, in which excipients make up the bulk of the tablet  16 Aug 2014 Keywords: Solid dosage form; Validation; Process validation; Tablet. The general properties of lactose that contribute to its popularity as an excipient are  efficiency make tablets the solid dosage form of choice. Daniel Peng, Ph. + + Dispersible tablets are a convenient formulation for infants, toddlers and pre-school children. Mini-tablets (Figure 1) are flat or slightly curved tablets with a diameter ranging between 1. Boundary lubricants will help up to greater extent. Chat Here Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris[1] and acts by dilating the blood vessels so as to reduce the blood pressure. Based on ICH Q3A FIG. The Q2(R2)/Q14 EWG will develop a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, with a view to potentially combine both documents into one, for simplification and clarity. ACG ACPL is the first empty hard capsule manufacturing company in Asia to receive EXCiPACT certification. CAPSULES – solid However, understanding the basics of compression is the key to understanding all tab- let presses. S. e. US Patent No. ii) LAMINATION: It is separation of tablet into two or more layers due to air-entrapment in the granular material. , and PATH in 2008. • Changes in the starting material(s). Tablet manufacturing speed and pre/main compression force profile also have an influence on the quality of the final tablet. 63 per kilogram of FPP (see online supplementary appendix ). 0 mm, they are primarily produced as an intermediary with a size range of 0. The tablets are marketed in PVC (polyvinylchloride) film - aluminium foil blisters, which are packaged with the Patient Information Leaflet (PIL) into cardboard outer cartons in pack sizes of 2, 4, 6, 8, 10, 12 and 16. Many excipients have multiple functions (e. The full text of this article hosted at iucr. As a result, it is critical that pharmaceutical manufacturing equipment comply with good manufacturing practice (GMP). 14 May 2011 Lactose is the most widely used filler-diluents in tablets. Now take an amount that contains 10 mg of API to 100 ml then 1 ml to 10 ml dilute with mobile phase. S. Conventional and chewable tablets are used to administer drugs to dogs and The word excipient is derived from the Latin excipere, meaning 'to except', which is simply explained as 'other than'. The excipient is of particular importance if the conventional tablet contains a bitter drug substance(s) or, more importantly, if the tablet is a chewable tablet. Film Coating Tablet Materials and Ingredients. London: Pharmaceutical Press, 2012. Structure elucidation of degradation products. 1. IJPSR [An official publication of Society of Pharmaceutical Sciences and Research (SPSR)] Sponsored National Conference on Recent Advancement in Pharmaceutical and Bio Sciences, organized by Oriental College of Pharmacy and Research, Oriental University, Indore (MP), India on dated September 17, 2019. [] Tablet Coating Defects and their Remedies Coating tablets with a thin polymer film can be an effective way to give your products a professional edge. ODT may be used without the addition of water. ConferenceSeries Ltd is a renowned organization that organizes highly notable pharmaceutical conferences throughout the globe. Sustained Release Dosage Forms Another form of coating is enteric coated tablets which are coated with a material which will dissolve in the intestine but remain intact in the stomach. 2 Jan 2016 Shamiul Bashar 1st Batch B. KEYWORDS: Systemic, pellets, granules, film-coated multiple units, diluents, compression, molding, tablet triturates. Buccal Patches Pharmaceuticals Talc is an ideal excipient for tablets, a carrier for medicated powders and a glidant and lubricant in tablet production. 2 Add a dosage unit to the water. 5 Figure 1: Mini-tablets Constituents of Mini-tablets Excipients are additive substances used in tablet formulation to improve bulkiness, disintegration, dissolution rate and bioavailability of the drug. 2012 | Ulrich Marcher | ©MEGGLE 2 Co- The full text of this article hosted at iucr. com/files/4. Inhalations: baximib injection 2 mg: 2 mg: bortezomib. 5. Each 500 mg tablet of Chloroquine phosphate contains the equivalent of 300 mg Chloroquine base. Second condition, higher compression force cause deformation, crushing or Dosage Form Design: Pharmaceutical and Formulation Considerations 4 SECTION II DRUG DOSAGE FORM AND DRUG DELIVERY SYSTEM DESIGN After reading this chapter, the student will be able to: 1. 1 Therapeutic indications Anti-inflammatory indications: Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, muscular aches, gelatinous layer on the tablet surface. Excipients 1. 4. 42 to enable blend homogeneity. Keywords: Lubricants, Compression, Friction, Fluid lubricant, Boundary lubricant. High quality tablets can be quickly and easily produced using a tablet coating machine and the correct excipients . TABLET DEFECTS : THE CAUSE AND THE REMEDY. The granulation process combines one or more powders and forms a granule that will allow the tableting process to be predictable and will produce quality tablets within the re-quired tablet-press speed range. Many excipients have more than one use, which can be an advantage since it reduces the number of excipients needed and minimises the risk of interactions between them. 4% Diluents: microcrystalline cellulose (~40%) and lactose monohydrate (~50%) Other excipients: disintegrant, wetting agent, and lubricant Manufacturing Process: To study the uniformity of diameter, thickness and hardness of antibiotic tablet using the tablet testing experiment ( PHARMATEST PTB 311). 1 should be evaluated. ) as an independent scientific expert. This yielded an estimated average excipient cost of US$2. 7 ±0. The specific objective was to find optimum formulations for direct compression tablet, using aspirin 150 mg as a model drug and to compare with commercial aspirin tablets. Eur. The dissolution rate is not only affected by nature of the diluent but also affected by excipient dilution (drug/excipient ratio). (slideshare. from tablet punches • Excipients Magnesium stearate (1-2%) Polyethylene glycol • Magnesium stearat should be mixed in late in production sequence • It can affect release from the tablet and tablet strength • One approach is to not include magnesium stearate in the formulation but to spray it on the punches during production. Handbook of Pharmaceutical Excipients, 7th edn. Keywords : Superdisintegrants, promethazine HCl, sodium starch glycolate, croscarmellose, crospovidone - D S Sandeep Introduction : The tablet is the most widely used dosage form because of its convenience in terms of self administration, compactness and ease in manufacturing. In terms of the final product, the excipient may be as important as the tablets or capsule the number of people who cannot swallow tablet or who dislike swallowing tablet and capsule is growing with an effervescent dosage form, one dose can usually delivered in just 3 or 4 ounces of water. 500mg: mycophenolate: immunosupressant: tablets: s10: benfomet: 100mg,0 Http Www Slideshare Net Binqlink Diagram Of Hammer Mill. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. Tablet types and Excipients 1. For products that contain more than one drug substance, the compatibility of the drug substances with each other should also be evaluated. 6,372,255 discloses multi-layer tablet for the instant and prolonged release of active substances comprising at least two layers where the first outer layer comprises a mixture of excipients and an active substance, allowing for the immediate release of the active substance of the first layer, and a second layer, comprising same issues associated with control of the manufacturing and the validation processes specific to some equipments such as Blenders, Dryers, Tablets and Capsule equipments, Coating equipment etc. Therefore, identification, quantification, and control of impurities in the drug substance and drug product, are an important part of drug development and regulatory assessment. 1 is a schematic representation of one embodiment of the instant invention wherein the device, 6, has a core composition comprised of drug(s), 3, solubility modulator(s), 2, surrounded by a rate modifying coat, 5, to form controlled release solubility modulating units that are dispersed among other excipients, 4, which may optionally contain elements found in 2, as needed to form a tablet suitable for the application of a microporous, rate-determining, water-insoluble wall, 1. B. As dosage form pills are very popular in J Ayurvedic medicine and are known as vati. • For all these problems the solution is to suitably pretreat the plastic chemically. 3-5 Introduction of matrix tablet as sustained release (SR) has given a new breakthrough for novel drug delivery system (NDDS) in the field of Pharmaceutical technology. Above a certain concentration, the glidant will in fact function to inhibit flowability. Tablet dosage form has number of potential advantages over the other solid dosage forms as well as liquid dosage forms such as: 1) DILUENTS  Diluents in capsule & tablet influence the dissolution rate of drug. • Improper storage conditions. It can strengthen the tablet, control its release, improve its taste, color it, make it easier to handle and package, and protect it from moisture. • IMPART WEIGHT, ACCURACY, & VOLUME • IMPROVE SOLUBILITY • INCREASE STABILITY • ENHANCE BIOAVAILABILITY • MODIFY DRUG RELEASE • ASSIST PRODUCT IDENTIFICATION • INCREASE PATIENT ACCEPTABILITY • FACILITATE DOSAGE FORM DESIGN These are the substances added in the Polymers Polymers like methyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose and others became the main coating materials. Oral delivery of proteins and peptides is a challenge due to their degradation in the stomach. 1 The FDA classifies as therapeutically equivalent products that are approved as safe and effective; are pharmaceutical equivalents (i. 5 mg and 5 mg Drug substance: BCS high solubility, non-hygroscopic, only one crystalline form known, excellent chemical stability API loading: 2. ++  Pharmaceutical Excipients: A review - ijapbc www. Cellulose has very semi-synthetic derivatives which is extensively used in pharmaceutical and cosmetic industries. Transfer of environmental moisture, oxygen, and other elements into the pharmaceutical product. microcrystalline cellulose, starch). Dissolution testing apparatus slideshare 2550rpm orally disintegrating tablets chewable tablets cr suspensions type 3 reciprocating cylinder 635rpm cr chewable tablets type 4 Dissertation oral tablets mouth Orally, solid oral odts, quick disintegrating tablets, rapimelts, encourage pre-gastric absorption. There are many reasons for formulating a tablet product with excipients, ranging from management of small dosage amounts of active ingredients to esthetic resons of colour and shape of a product. The medicament and the excipients are rendered to a cohesive mass with a suitable moistening agent and the mass is pressed through a sieve of required granule size and dried. • The improper size either large or small particles enhances color distribution. For that reason, this article will have two distinct sections, where I will exhaustively discuss each of these aspects. Dusting powders – locally applied non-toxic preparations that are intended to have no systemic action. Therefore, excipients are used not only to enhance the performance of ac-tive ingredients, but also to simply make the active work better on the tablet press. Whitehead et al have demonstrated good correlation between In vitro and in vivo buoyancy of floating dosage forms [16]. Tablets •WHO guidelines on good manufacturing practices for heating, ventilation and air‐ conditioning systems for non‐sterile Guidance on CMC for Phase 1 and Phases 2/3 Investigational New Drug Applications Charles P. In fact, a tablet represents a mixture of one or more active ingredients with a figure of “ inactive ” ingredients or excipients. Tablets: These are solid dosage forms in which the medicament is compressed in different shapes and sizes. 4 Oct 2015 A seminar ON Excipients PRESENTED BY RAJENDRA D. October 6, 2015 . Automatic Tablet Coater is designed for the application of: EUROPEAN PHARMACOPOEIA 7. SIC is useful for proteinous drug products with excipients. 0 5. The key properties of the dosage unit, including dosage form type (tablet, capsule), expected number of potencies and desired release mechanism plus specific formulation information such as excipients, lubricants, disintegrants, moisture content, surface coating and known stability issues (cross-linking, friability) are all important factors to consider. Direct compression is a popular choice because it provides the shortest, most effective and least complex way to produce tablets. 8. The pharmaceutical industry has the most precise requirements and manufacturing guidelines in terms of quality. The IR shows that all peaks are present in the drug are present in the physical mixture and tablet. Disintegrants and superdisintegrants are used in tablets and capsules to ensure the rapid break down into their primary particles, facilitating the dissolution or release of the active ingredients. The higher viscosity grades of HPMC though provided film with good tensile strength but produces films having poor adhesion with the core surface and very often one can easily peal-off the film from the tablet surface. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Powders: The medicament with or without excipient in fine state of subdivision is supplied in either bulk or individually wrapped in a paper. The manufacturer can blend an API with the excipient and the lubricant, followed by compression, which makes the product easy to process. The process makes use of conventional excipients and therefore is not dependent on the inclusion of special grades of excipients. There is lack of awareness that the excipients behave differently, depending upon the vendor (i. Most conventional (immediate release) oral drug products, such as tablets and capsules, are . Film coating involves the deposition of a thin polymer layer onto the tablet core, usually by a spray method. Last updated on Dec 1, 2018. of excipients (and mixtures) and to determine the appropriate IID maximum for ANDA references that cover these grades. Excipient III. An Open Access Publisher & Scientific Events Organizer and other Open Access Resources Pharmaceutical Technology Capsules Dr. Typical costs of excipients used in tablets and typical proportion of the FPP made up by each excipient were combined, and excipients were assumed to represent 50% of total tablet weight. ijapbc. The most important contribution of microbiology to the pharmaceutical industry is the development of antibiotics. Tablets are the most common forms of oral drug, comprising a mixture of active substances and excipients which are formulated to produce an accurate dosage specific to a particular disease. 0 mm. Reduced Polymers Polymers like methyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose and others became the main coating materials. Executive Director, Pfizer Board Member, FDA Alumni Association DEVELOPMENT AND VALIDATION OF AN UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF ALISKIREN IN TABLETS Micheli Wrasse-Sangoi*, Leonardo Trevisan Secretti, Isabel Fração Diefenbach e Clarice Madalena Bueno Rolim Departamento de Farmácia Industrial, Universidade Federal de Santa Maria, 97105-900 Santa Maria - RS, Brasil components, excipients and other active ingredients, in the case of combination products. Widely used fillers are lactose, dextrin, microcrystalline cellulose, starch, pregelatinized starch, powdered sucrose, and calcium phosphate. Ability to withstand the shock of handling, packing and shipping b. 3 primary components of tablet coating are tablet properties, SPH SPH IHBK039-fm IHBK039-Niazi-FM May 26, 2009 22:33 Char Count= Handbook of Pharmaceutical Manufacturing Formulations Second Edition Volume Series Tablet types and Excipients 1. 5 mg and 10 mg. Tablet presses are designed with following basic components: 1) Hopper for holding and feeding granulation 2) Dies that define the size and shape of the tablet. A tablet formulation contains several ingredients, and the ac- The medicinal product will comprise the active substance formulation (tablet, cream, suspension, solution), excipients (inactive ingredients such as lactose), and packaging/delivery device (blister pack, bottle, inhaler, vial, prefilled syringe). In pharmaceutics, sink condition is a term mostly related to the dissolution testing procedure. Galenic formulation for non-clinical studies. Pessaries: of all excipients in their products to ensure that they are internationally approved, non-toxic and have a low potential to cause adverse effects such as hypersensitivity. Prophylaxis against Chloroquine-sensitive Plasmodium species Tablets Information. ppt), PDF File (. Absorption (pharmacokinetics) · Dissolution testing · Pharmaceutical formulation · Tablet (pharmacy) · Tablet hardness testing   A glidant is a substance that is added to a powder to improve its flowability. 3 After 30 minutes, record your observations as yes, no or partially melts on the scale provided. New pharmaceutical excipients in solid dosage forms – A review Hardik Patel *, Viral Shah and Umesh Upadhyay Department of Pharmaceutics, Sigma institute of Pharmacy, Baroda, (Gujarat) - India Abstract The objective of a medicinal formulation development project is to deliver drug to the patient in the required Techniques of Tablet Coating: Concepts and Advancements: A Comprehensive Review. Keywords: superdisintegrants, dissolution rate, polymers, ion exchange resins. tablet die wall interface results from the shearing of junctions between the tablet and wall material (Lachman et al. “Excipients are no longer passive carriers or so-called ‘inactive ingredients’. Wet Granulation: The Ultimate Guide for Beginners and Professionals In this guide, you are going to learn about two critical aspects – wet granulation process and wet granulation machines. ” Role of excipient Protect, support or enhance stability of the Formulation. C. In this case right dosage strength need not be readily commercially available for every patient The patient suffers from the allergy on a specific excipients (e. M. intake, which will aid and increase the disintegration of the tablets. For the starches, however, the decrease in density did not occur until monolayer water coverage was reached. Common terms for Impurities10 1. Tablet excipients. Opinions expressed in this presentation are those of the speakers and A wide range of tablet types is available, offering a range of drug release rates and durations of clinical effect. Office of Process and Facility (OPF) OPQ/CDER/FDA . Bulk up the formulation in case of potent drug for The dosage of Chloroquine phosphate is often expressed in terms of equivalent Chloroquine base. According  Excipients are inactive ingredients used as carriers for the active ingredients in a Antiadherents are used to keep the powder from sticking to the tablet punch  1 Aug 2011 Pharmaceutical excipients are basically everything other than the active pharmaceutical Table 1 Common excipients used in tablets  Excipients are additive substances used in tablet formulation to improve bulkiness, disintegration, dissolution rate and bioavailability of the drug. A tablet consists of one or more active ingredients and numerous excipients and may be a conventional tablet that is swallowed whole, a chewable tablet, or a modified-release tablet (these are commonly referred to as modified-release boluses when the unit size is large). Our excipients for oral liquid dosage forms include thickeners, stabilizers, binders, solubilizers, non-alcohol diluents, film-formers and products that help with water retention. Microbiological quality of non-sterile products for pharmaceutical use 01/2011:50104 5. Aalok Basu , Anjan De *, and Suddhasattya Dey. All antibiotics were originally the products of microbial metabolism, however the recent genetic manipulations have enabled the production of more enhanced drugs. Such dosage form could be very beneficial for use in IMPORTANCE It is important for the evaluation of the properties of tablets: a. Chapter 1 (“Main principles for pharmaceutical products”) includes the core GMP guidelines, as well as GMP guidance texts for the heating, ventila- design in the tablet optimization. The relative in tablet manufacture exist in a variety of solid- volume is V′/V0 = V = 1/D, C1 is constant. According to the Indian Pharmacopoeia, pharmaceutical tablets are solid flat or formulation field; Romanski says that excipients also have an important role to play. ODT have been developed to disintegrate rapidly in the saliva after oral administration. Although granules used in the pharmaceutical industry have particle size in the range of 0. The accuracy or condition of slug is not too important. Oral liquid dosage forms include solutions, syrups, suspensions, elixirs and concentrates. of the dosage unit. A tablet seldom consists of merely the active ingredient. Dispersible tablets are uncoated or film-coated tablets that can be dispersed in liquid before administration giving a homogenous dispersion. 2. INTRODUCTION: Audit and inspection are the most important functions of a manufacturing facility. - Free download as Powerpoint Presentation (. There are many grounds for explicating a tablet merchandise with excipients, runing from direction of little dose sums of active ingredients to esthetic resons of coloring material and form of a merchandise. Drawback: Lack of physical flexibility, poor patient compliance. CHEWABLE TABLETS Tablets are to be broken & chewed in between the teeth before ingestion. Tablet dosage form has number of potential advantages over the other solid dosage forms as well as liquid dosage forms such as: Pharmaceutical Excipients PDF Free Download E-BOOK DESCRIPTION This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. Efforts are being made continually to understand more clearly the physical Drug-excipient interaction and its importance in dosage form development Nishath Fathima, Tirunagari Mamatha, Husna Kanwal Qureshi, Nandagopal Anitha and Jangala Venkateswara Rao Excipients are included in dosage forms to aid manufacture, administration or absorption. Tablets are solid dosage forms each containing a unit dose of one or more active ingredients. P. The BLT and TFT of tablets were shown in table 4. This bibliography was generated on Cite This For Me on Sunday, March 8, 2015 multiple excipients. They can be hydrophobic or hydrophilic. Shown to be related to solubility Deviation of diameter %= (Ave. The tablet press is the report card on all previ- ous unit operations; the tablet press is only half responsible for the final tablet quality, the formula and powder prepara- tion operation is the other half. It is sold by AstraZeneca under the trade name Imdur. RATE CONTROLLED DRUG DELIVERY SYSTEM – ACTIVATION MODULATED1. 20 Jun 2013 Recent developments in fast disintegrating tablets have brought by in vitro dissolution test, drug-excipient compatibility, and accelerated  excipients compatibility study showed no interaction between drug and excipients. These data are to be included in the forth-coming publication of the Handbook of Pharmaceutical E Excipient Toxicity and Safety edited by Myra Weiner and Lois Kotkoskie. It is used in enteric coatings for targeted delivery of drugs. This set of tables is an update of the orginal "Stability data for commonly used vaccines and novel formulations," produced by Working in Tandem, Ltd. 3 Novel Excipients 3. List of polymer used in floating drug delivery systems are shown in Table 1. Tablet types and Excipients. Adsorption or absorption of the active drug or excipients by the plastic. Drug products contain both drug substance (commonly referred to as active pharmaceutical ingredient or API) and excipients. diagram of horizontal and vertical milling machine . Tablets can be applied to different sites in the oral cavity. Thus the lubricant is thought to offer a lower shear interface than that characteristic of the die wall tablet surfaces and will thus readily shear when tangential motion is "In addition to its tablet coatings, SEPPIC offers a range of services to assist its customers. 2 Medical Device 3. An important physical parameter in the control of tablets c. ZYPREXA ZYDIS wafers also contain excipients: gelatin, mannitol,  30 Jun 2016 disintegrating tablets has been growing, during the last decades especially . Conventional sugar panning equipment can be used but more specialized machinery, such as the side-vented pan, is used to control the processing conditions, which include temperature, humidity, spray rate and mixing of the tablet bed. Drug excipients studies, FT-IR spectroscopic studies and The final oral multiple-unit dosage form can be either a hard gelatin capsule filled with pellets or a tablet composed of carefully compressed pellets. SUBLINGUAL TABLETS These tablets should be formulated with bland excipients, which do not stimulate salivation. org is unavailable due to technical difficulties. These are the sources and citations used to research excipients in tablet manufacruring. Stability considerations in dispensing practice for suppositories also include observations on excessive softening and oil stains on packaging. Bhawna Bhatt Delhi Institute of Pharmaceutical Science and Research Sector – 3, Pushp Vihar New Delhi Prof. Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. With these technologies, drug and excipients are mixed with polymers such as hydroxypropyl methylcellulose (HPMC) and hydroxypropyl cellu-lose (HPC), and then formed as a tablet by conven-tional compression. Rowe et al. Highly water soluble and quickly dissolvable sugar-based excipients are mannitol,  Process combines the drug and excipients into the dosage form Dry granulation (roll compaction); Wet granulation; Drying; Tablet compaction; Coating. The drug and excipient interaction study is carried using Infrared Spectrum to know the stability of excipients and drug. Your search terms and filters produced no results. It ensures better content uniformity, especially for soluble low-dose drugs. 1 FDA/PQRI 2nd Conference. tablet, decrease porosity & hence penetrability of solvent into the tablet retard the wettability by forming a firmer & more effective sealing layer by the lubricant and in many case tighter bonding between the particle so decrease dissolution rate of tablet. There are two main types of mill: . Polymeric acid compounds have been used for this purpose with some success. A disintegrant is an excipient, which is added to a tablet or. Based on ICH Q3A This polymer has versatile uses in many industries such as veterinary foods, wood and paper, fibers and clothes, cosmetic and pharmaceutical industries as excipient. Assay of Sodium valproate in tablet dosage form: Twenty tablets were weighed and convert it into powder form, then take equivalent of Tablet coating is the key step involved in the manufacturing of tablets having controlled release, delayed release profiles. Binders ensure that  31 Mar 2016 Information about excipients and their properties. ppt) Drug formulations with these excipients provide extended drug release for hours. has good tablet characteristics such as uniform content or con-sistent hardness. Professionals from national authorities (e. 5 mm to be either packed as a dosage form or be mixed with other excipients before tablet compaction or capsule filling. Excipient An excipient is an inactive substance formulated alongside the active ingredient of a medication, for the purpose of bulking-up formulations that contain potent active ingredients. A tablet is a pharmaceutical dosage form. Metoprolol Succinate is the succinate salt form of metoprolol, a cardioselective competitive beta-1 adrenergic receptor antagonist with antihypertensive properties and devoid of intrinsic sympathomimetic activity. The fluid contains a solvent which can be removed by drying, and should be non-toxic. , lactose – a filler, some colorizing/flavouring or antimicrobial agents - parabens) or another drug appearing in the PP Patient is unable to use a PP in its commercially available Effervescent tablets are an interesting pharmaceutical dosage form, offering some unique advantages when compared with simple tablets. •Designed not to disintegrate but to slowly dissolve, Pharmaceutical excipients. The purpose of this research work to prepare a sustained release matrix tablet of Theophylline. pdf 11 Sep 2018 ZYPREXA® film-coated tablet, 2. For excipients see Section 6. The Tablet presses, also called tableting machines, range from small, inexpensive bench-top models that make one tablet at a time (single-station presses), with only around a half-ton pressure, to large, computerized, industrial models (multi-station rotary presses) that can make hundreds of thousands to millions of tablets an hour with much greater pressure. The common principle underlying this drug administration route is the adhesion of the dosage form to the mucous layer until the polymer dissolves or the mucin replaces itself. 8 Tablet diameter: 20mm. Different grades of hydroxypropyl methyl cellulose were evaluated for gel forming properties. a well labelled diagram of a hammer mill; LIVE CHAT. 480 Mannitol. Wet granulation involves the massing of a mix of dry primary powder particles using a granulating fluid. Disintegrants ( Added to a tablet formulation to facilitate its breaking or disintegration  2 Feb 2017 Drug Excipients Diluents Disintegrant Large sized tablets Slugs Granules Disintegrant Glidant Lubricant tablets Compression granulation 17  23 Dec 2016 commonly used tablet ingredients and their specific role in tablet production. It is a high efficiency, energy saving, safe and clean equipment for film and sugar coating of tablets, Pills and candies with organic film, aqueous coating and sugar film etc. To study the uniformity of diameter, thickness and hardness of antibiotic tablet using the tablet testing experiment ( PHARMATEST PTB 311). 1 Process Validation and or Evaluation 3. com • Standard compressed tablets can take 30 minutes or longer to dissolve • Compressed tablets require significant excipients, binders and non-nutritive … Training Program cGMP in the USA Nicholas Buhay Deputy Director Division of Manufacturing & Product Quality Office of Compliance, CDER, FDA An Outline Legal bases for – A free PowerPoint PPT presentation (displayed as a Flash slide show) on PowerShow. These forms often show difference in coefficient L is referred to as the pressing modulus 30. Excipients are the additives used to convert pharmacologically active compounds into pharmaceutical dosage forms suitable for administration to patients. The body is first filled with the mix of active ingredients and any excipients used, and then closed with the cap using either a manual or automatic press machine. II. Hoiberg, Ph. They offer better patient compliance in people who find swallowing pills or capsules difficult, and more flexible dosage control than a fixed-dose tablet. , 1970). Study of the compaction behaviour and compressibility of binary mixtures of some pharmaceutical excipients during direct compression Article in Chemical Engineering and Processing 48(4):859-863 The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. Roy College of Pharmacy & Allied Health Sciences, Bidhan Nagar, Durgapur-713 206, WB. The terms important to generic substitution are summarized in TABLE 1. microcrystalline cellulose). What is it? Hypromellose, also commonly known as hydroxypropyl methycellulose (HPMC) is a coating agent and film-former used as an inactive ingredient in the pharmaceutical industry. 2-4. The present study comprises the various kinds of superdisintegrants which are being used in the formulation to provide the safer, effective drug delivery with patient's compliance. Lubricant: magnesium stearate 0. To overcome this challenge, ragweed (Ambrosia elatior) pollen grains were engineered to serve as protective microcapsules. O SlideShare utiliza cookies para otimizar a funcionalidade e o desempenho do site, assim como para apresentar publicidade mais relevante aos nossos usuários. Interactions of it with different types of buffers were A) Drug-Excipient compatibility studies in solid dosage forms Tablet manufacturing processs and defects of tablets. Many types of excipients are used in tablet formulations to help in The compatibility studies were performed with excipients which may come in contact with the drug.  The diluent is selected based on various factors, Pharmaceutical excipients. EX: INF – Tau – A new anti- viral drug. In pharmaceutical coatings, talc is an excellent anti-tack agent. Fillers: Fillers typically also fill out the size of a tablet or capsule, making it practical to produce and convenient for the consumer to use. Effervescent tablets are uncoated tablets that generally contain acid substances and carbonates or bicarbonates and which react rapidly in the presence of water by releasing carbon dioxide. Determination of degradation pathways of drug substances and drug products. Download: PPT. 4 Mdii l dt tii i i Medicinal products containing or using in the manufacturing process materials of animal and / or human origin. As a consequence, excipients with optimal functionality are needed to ensure smooth tablet production on modern machines (11). , eds. Remedy: • Lettering should be designed as large as possible, even the tablet size can be increased by reformulation • Colloidal silica can be added as polishing agent to formula • Using additional binder to increase cohesiveness of granules and thereby causing decreased adherence This video explains tablet manufacturing process by dry granulation. What Extended Drug Release Excipients As the name implies, extended release excipients are designed to increase the time the drug is available in the body. INTRODUCTION Disintegrants are agents added to tablet and some tablet with floating ability to prolong the gastric residence time of triple drug regimen (tetracycline, metronidazole and clarithromycin) in Helicobacter pylori-associated peptic ulcers using HPMC and PEO as the rate-controlling polymeric membrane excipients. This topic was endorsed by the Assembly in June 2018. Excipients are used in most drug products and the quality of the materials, manufacturing processes, and test methods are vital to the production of safe, effective therapies. " Formulation support SEPPIC performs customers dedicated trials in its application lab to carefully select the right products that best fit the needs and requirements of customers. net) preparations; The excipients form the major part of any medicinal product and proportion of it when compared to Active Pharmaceutical Agent (API) exceeds two to three fold in any pharmaceutical preparations. 9 Mar 2015 This presentation describes the tablet types and excipients used in tablet manufacturing. Changes in flowability and dynamic density of excipients can significantly impact tablet formation and therefore the moisture content of the excipients should be carefully monitored and controlled. Non-clinical safety studies aim to: With stirring type of agitation, order was potato starch>cornstarch>arrowrootstarch>ricestarch. RRegional Information/ Requirements 3. North Bethesda, Maryland . •Release drug contents for absorption directly through oral mucosa. The MAH has stated that not all pack sizes may be marketed. How to Identify Critical Quality Attributes and Critical Process Parameters Jennifer Maguire, Ph. tablet excipients slideshare

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