Tablets 399999999999999999999999999.pptx

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1. SOLID DOSAGE FORMS (ENTERIC, OTHER COATINGS, AND QC EVALUATION) PABITRA SUBEDI

2. ENTERIC COATING Used to protect tablet core from disintegration in the stomach . Stomach has acidic environment. Prevents drug release before dosage form reaches intestine.

3. ENTERIC COATING Used to protect tablet core from disintegration in the stomach . Stomach has acidic environment. Prevents drug release before dosage form reaches intestine. Importance To prevent degradation of acid sensitive API . To prevent irritation of stomach by certain drugs like sodium salicylate. Delivery of API into intestine . To provide a delayed release.

4. ENTERIC COATING Importance To prevent degradation of acid sensitive API . To prevent irritation of stomach by certain drugs like sodium salicylate. Delivery of API into intestine . To provide a delayed release.

5. ENTERIC COATING One layer Coating formulation is applied in one homogenous layer. Can be white, opaque, or coloured . Benefit is only one application is needed. Two layer For higher quality and better-looking tablets. Enteric + coloured film. Both can be enteric polymer . Or basic layer is enteric and top layer is fast disintegrating water-soluble polymer.

6. ENTERIC COATING

7. ENTERIC COATING Ideal properties of enteric coating material: Resistance to gastric fluids. Susceptible/permeable to intestinal fluid. Compatibility with most coating solution components and the drug substance. Formation of continuous film. Non-toxic, cheap, and ease of application. Ability to be readily printed. Insoluble in low pH and soluble in high pH.

8. ENTERIC COATING POLYMERS Cellulose acetate phthalate (CAP) Widely used. Dissolves above pH 6 only. Delays absorption of drugs. Hygroscopic and permeable to moisture in comparison with other enteric polymer. Susceptible to hydrolytic removal of phthalic and acetic acid changing film properties. CAP films are brittle and usually used with other hydrophobic film forming materials.

9. ENTERIC COATING POLYMERS Acrylate polymers Eudragit L and Eudragit S. Two commercially available forms. Enteric acrylic resins. Eudragit L is soluble at pH 6. Eudragit S is soluble at pH 7. Eudragit L is available as an organic solution, solid, or aqueous dispersion. Eudragit S is available only as organic solution and solid. Isopropanol- organic solvent.

10. ENTERIC COATING POLYMERS H ydroxypropyl methyl cellulose phthalate Aka Hypromellose phthalate. Various grades. HPMCP 50, 55, and 55-s is widely used. Also called HP-50, HP-55, and HP-55-s. HP-55 is recommended for general enteric preparation. HP-50 and HP-55s for special cases. Dissolve at pH 5.0-5.5.

11. OTHER COATINGS Enteric sugar coating Sealing coat is tailored to include one of the enteric polymers. In sufficient quantity. Should pass the disintegration test for enteric coating. Should disintegrate within 60 minutes. Subsequent sub-coating and coating steps as per conventional sugar-coating method.

12. OTHER COATINGS E nteric film coating Utilizes the ability of enteric polymers to form direct films. In film coating process. Sufficient weight of enteric polymer has to be used. To ensure efficient enteric effect. Polysaccharides can be added. Enzymatic degradation in colon. E.g., Cyclodextrin and galactomannan.

13. OTHER COATINGS Compressed Coating Electrostatic Coating Dip Coating Vacuum Film Coating

14. OTHER COATINGS Compressed Coating Requires specialized tablet machine. Seldom used. Advantages in some cases. For tablet core intolerant for organic solvent or water. Yet coating is required for taste masking. To provide delayed or enteric properties to final product. To avoid incompatibility.

15. OTHER COATINGS Electrostatic Coating Efficient method of coating conductive substrates. Strong electrostatic charge is applied to substrate. Coating material containing conductive ionic species of opposite charge is sprayed onto the charged substrate. Disadvantages: Complete and uniform coating of corners is difficult. Adaptability to non-conductive or relatively less conductive substrate is limited.

16. OTHER COATINGS Compressed Coating Electrostatic Coating Dip Coating Vacuum Film Coating Requires specialized tablet machine. Seldom used. Advantages in some cases. For tablet core intolerant for organic solvent or water. Yet coating is required for taste masking. To provide delayed or enteric properties to final product. To avoid incompatibility. Efficient method of coating conductive substrates. Strong electrostatic charge is applied to substrate. Coating material containing conductive ionic species of opposite charge is sprayed onto the charged substrate. Disadvantages: Complete and uniform coating of corners is difficult. Adaptability to non-conductive or relatively less conductive substrate is limited. Tablets are dipped into the coating solution/suspension. Wet tablets are dried in a conventional manner in a coating pan. Process can be repeated in an alternate manner between dipping and drying. To obtain the desired coating. Disadvantages: Slow, less versatile, and lacking reliability of spray-coating techniques. Specialized equipment for dip-coating. No pharmaceutical application.

17. OTHER COATINGS Compressed Coating Electrostatic Coating Dip Coating Vacuum Film Coating Requires specialized tablet machine. Seldom used. Advantages in some cases. For tablet core intolerant for organic solvent or water. Yet coating is required for taste masking. To provide delayed or enteric properties to final product. To avoid incompatibility. Efficient method of coating conductive substrates. Strong electrostatic charge is applied to substrate. Coating material containing conductive ionic species of opposite charge is sprayed onto the charged substrate. Disadvantages: Complete and uniform coating of corners is difficult. Adaptability to non-conductive or relatively less conductive substrate is limited. Tablets are dipped into the coating solution/suspension. Wet tablets are dried in a conventional manner in a coating pan. Process can be repeated in an alternate manner between dipping and drying. To obtain the desired coating. Disadvantages: Slow, less versatile, and lacking reliability of spray-coating techniques. Specialized equipment for dip-coating. No pharmaceutical application. A novel method. Employs a specially designed baffled pan. Pan is hot water-jacketed. Sealed to achieve vacuum system. Tablets in pan. Air in pan is replaced with nitrogen. Coat is applied with airless spray system. Evaporation is caused by the heated pan.

18. OTHER COATINGS Compressed Coating Electrostatic Coating Dip Coating Vacuum Film Coating Requires specialized tablet machine. Seldom used. Advantages in some cases. For tablet core intolerant for organic solvent or water. Yet coating is required for taste masking. To provide delayed or enteric properties to final product. To avoid incompatibility. Efficient method of coating conductive substrates. Strong electrostatic charge is applied to substrate. Coating material containing conductive ionic species of opposite charge is sprayed onto the charged substrate. Disadvantages: Complete and uniform coating of corners is difficult. Adaptability to non-conductive or relatively less conductive substrate is limited. Tablets are dipped into the coating solution/suspension. Wet tablets are dried in a conventional manner in a coating pan. Process can be repeated in an alternate manner between dipping and drying. To obtain the desired coating. Disadvantages: Slow, less versatile, and lacking reliability of spray-coating techniques. Specialized equipment for dip-coating. No pharmaceutical application. Vapour is removed by vacuum system. Low-velocity heated air provides advantages like: Energy requirement is low. Coating efficiency is high. Organic solvent can be effectively used. Minimum environmental effect. Relatively safe method.

19. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Disintegration Moisture content Microbial limit Identification

20. EVALUATION/QUALITY CONTROL TEST Weight variation Purpose: To ensure uniformity in tablet weight Procedure: Weigh a specified number of tablets individually, calculate the average weight, and then compare each tablet's weight to the average. Content uniformity Hardness Thickness Dissolution Friability Disintegration Moisture content Microbial limit Identification IP/BP (Wt. of tablet) USP (Wt. of tablet) LIMIT (%) 80 mg or less 130 mg or less 10 More than 80 mg or less than 250 mg 130 mg to 324 mg 7.5 250 mg or more More than 324 mg 5

21. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Purpose: To ensure that the active pharmaceutical ingredient (API) is distributed uniformly throughout the tablet batch. Procedure: Analyze the content of the API in multiple tablets using a validated analytical method. Compare the results to the specified limits. Hardness Thickness Dissolution Friability Disintegration Moisture content Microbial limit Identification For potent drugs- NLT 90% and NMT 110%. For other drugs- NLT 95% and NMT 105%. 10 tablets assayed individually. 9 must be ± 15% and 10 th must be ± 25% in range.

22. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Purpose: To measure the tablet's resistance to crushing or breaking. Procedure: Use a hardness tester to measure the force required to break or deform the tablet. Results are compared to the specified range. Thickness Dissolution Friability Disintegration Moisture content Microbial limit Identification Determined by diametric compression test . Flat beveled tools produce harder tablets than deep cup.

23. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Purpose: To ensure uniformity in tablet thickness. Procedure: Measure the thickness of a sample of tablets using a calibrated thickness gauge. Compare the results to the specified limits. Dissolution Friability Disintegration Moisture content Microbial limit Identification

24. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Purpose: To assess the rate and extent of drug release from the tablet. Procedure: Submerge tablets in a dissolution apparatus, simulate physiological conditions, and measure the amount of dissolved drug at specified time intervals. Results are compared to dissolution profiles. Friability Disintegration Moisture content Microbial limit Identification

25. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Purpose: To measure the tablet's resistance to abrasion or breakage during handling and transportation. Procedure: Tumble a sample of tablets in a friabilator , and then measure the percentage of weight loss. Results are compared to specified limits. Disintegration Moisture content Microbial limit Identification Usually at 25 ± 1 rpm. Height of 6 inches usually. Usually 100 revolutions. For tablets <650 mg- tablets ~ 6.5 g in total weight For tablets >650 mg- 10 tablets. Friability (f)= (1-final weight/initial weight) x 100

26. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Disintegration Purpose: To determine the time it takes for a tablet to disintegrate into smaller particles in a simulated gastrointestinal environment. Procedure: Immerse tablets in a disintegration apparatus, and observe the time required for complete disintegration. Results are compared to specified limits. Moisture content Microbial limit Identification TYPE OF TABLET DT TIME (Minutes) Uncoated 15 Dispersible 3 Effervescent 5 Coated 60 Film-coated 30 6 glass tubes. One tablet for each. Vessel contains simulated intestinal fluid or water. Temp. of 37˚C ± 2˚C.

27. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Disintegration Moisture content Purpose: To ensure that the tablets have the appropriate moisture content. Procedure: Use a moisture analyzer to determine the moisture content of a sample of tablets. Results are compared to specified limits. Microbial limit Identification

28. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Disintegration Moisture content Microbial limit Purpose: To ensure that tablets are free from microbial contamination. Procedure: Perform microbial testing on a sample of tablets using appropriate methods. Results are compared to specified limits. Identification

29. EVALUATION/QUALITY CONTROL TEST Weight variation Content uniformity Hardness Thickness Dissolution Friability Disintegration Moisture content Microbial limit Identification Purpose: To confirm the identity of the active pharmaceutical ingredient. Procedure: Use validated analytical methods (e.g., spectroscopy) to identify the presence of the API in the tablet. Results are compared to reference standards.

30. EVALUATION/QUALITY CONTROL TEST General appearance Visual identity and overall elegance is essential for: Consumer acceptance Control of lot-to-lot uniformity Tablet-to-tablet uniformity Ensure error-free manufacturing Ensure product identification Ensure company trademark

31. EVALUATION/QUALITY CONTROL TEST Control of general appearance includes: Size Shape Colour Presence or absence of odour Taste Surface texture Consistency Legibility of any identifying markings

32. EVALUATION/QUALITY CONTROL TEST Size and shape Die cavity determines shape and dimension. Only variable is thickness. With constant compressive load, fill alters thickness. With constant fill, compressive load alters thickness. Thickness variation- ± 5% of standard value. To ensure uniformity: Consistent particle size and size distribution Tooling is consistent Press is clean and in good working order

33. EVALUATION/QUALITY CONTROL TEST Colour / odour /taste Should be consistent for: A single tablet Tablet to tablet Lot to lot Both presence or absence of odour is important. Absence- vitamins have characteristic odour Presence- Odour of acetic acid in degrading aspirin Taste is especially important for chewable tablets. These are subjective.