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Tablet a solid dosage form.


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Detail description on tablet as per PCI syllabus with its defects of tablet and quality control test.

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Tablet a solid dosage form.

  1. 1. UNIT 2: TABLETS According to PCI syllabus By Shaikh Saniya B.Pharm
  2. 2. Introduction • A tablet is a pharmaceutical oral dosage form (OSD). • Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients and prepared either by molding or by compression. • It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose. The excipients can include diluents, binders or granulating agents, glidants (flow aids) and lubricants to ensure efficient tabletting; disintegrates to promote tablet break-up in the digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually attractive or aid in visual identification of an unknown tablet.
  3. 3. • A polymer coating is often applied to make the tablet smoother and easier to swallow, to control the release rate of the active ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance the tablet's appearance. • The compressed tablet is the most popular dosage form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets. • Tablets are often stamped with symbols, letters, and numbers, which enable them to be identified. Sizes of tablets to be swallowed range from a few millimeters to about a centimeter.
  4. 4. CHARACTERTICS OF TABLET: • The tablet is an essentially tamperproof dosage form. • They are unit dose form and offer the greatest capabilities of all oral dosage forms for greater dose precision. • Lightest and most compact of all oral dosage form. • Their cost is low. • Easiest and cheapest to package and shipping. • Product identification is simple. • Provide greatest ease of swallowing with the least tendency for hang up, above stomach. • They may be enteric or delay release. • Better suited for large scale production. • They have the best combination properties of chemical, mechanical and microbiological stability than other oral dosage forms. • Tablets have accurate dose.
  5. 5. Classification of Tablets: 1.Oral tablet for ingestion 1.Compressed tablet/standard tablet 2.Multiple compressed tablets a. Layered tablet b. Compression coated tablet 3.Chewable tablets 4.Sugar and chocolate coated tablet 5.Film coated tablet 6.Repeat action tablet 7.Delayed action and enteric coated tablet 8.Controlled release tablet
  6. 6. 2.Tablet used in the oral cavity 1.Buccal and sublingual tablet 2.Troches and lozenges 3.Dental cones 3. Tablets administrated by other routes 1. Implants tablets 2. Vaginal tablets 4. Tablets used to prepare solution 1.Effervescent tablets 2.Dispensing tablets 3.Hypodermic tablets 4.Tablet triturates
  7. 7. GRANULATION METHOD 1. Dry granulation 2. Wet granulation 1. DRY GRANULATION METHOD a. Dry method of direct compression. b.Compression granulation c.Wet granulation
  8. 8. a.Direct compression 1. Crystalline substance like sodium chloride ,KCl,that may be compressed directly. 2. The compression of a single substance may produce tablet that do not disintegrate. 3. The use of diluents with many moderate dose drugs makes this process the most streamlined method of tablet manufacture. 4. Direct compression material in addition to processing good flow and compressibility, must be insert, tasteless, rework able to disintegrate and inexpensive. 5. Some of the limitation to process are,
  9. 9. a. Difference in particles size and bulk density between drug and diluents may lead to stratification within granulation which ultimately leads to weight variation. b. A large drug dose may lead problem with direct compression if it is not easily compress itself. c. In some case ,the direct compression diluents may interact with Amine compound reacts with lactose gives yellow colouration. d. Static charge produce during compression may prevent uniform distribution of drug in the granulation.
  10. 10. b.Compression granulation: 1. It is a valuable technique in situations where the effective dose of a drug is too high for direct compaction and the drug is sensitive to heat ,moisture or both. 2. Many Aspirin and Vitamin formulations are prepared by compression granulation. 3. It involves the compaction of components of a tablet formulation by means of a tablet press or specially designed machinery, followed by milling and screening prier to final compression into a tablet. 4. The masses formed where the initial blend of powers is forced into dies and is compacted by means of flat-faced punches are called slugs and process as slugging. 5. Slugs are then screened or milled to produce a granular form tableting material. 6. Slugging in just an elaborate method of subjecting material to increased compression time.
  11. 11. 7.Two or more times that the material is subjected to compaction pressure causes a strengthening of bonds that hold the tablet together and the resultant granules also increases the fluidity of powder mixture. 8.This method requires less equipments and space than other methods. 9.On large scale, compression granulation can be performed on a special designed machine called a roller compactor , which can produce as much as 500kg/hr or more compacted ribbon like material.
  12. 12. 2. Wet granulation 1. The unique portion of wet granulation process involves the wet massing of powders, wet sizing or milling, and drying. 2. Wet granulation focus on the granules by binding the powders together with an adhesive, instead of by compaction. 3. The wet granulation technique employs a solution, suspension or slurry containing a binder which is usually added to the powder mixture. 4. The liquid bridges are developed between particles and tensile strength of bonds increases. 5. Once the granulating liquid is added, mixing continues until a uniform dispersion is attained and all binders are activated. 6. As the liquid content increase it gives rise to funicular state.
  13. 13. 7.Then the capillary state is reached in which the void spaces within te granules are entirely eliminates. 8.Further addition of liquid results in droplets formation. 9.The liquid plays a key role in the granulation process. 10.Once granulating liquid has been added mixing continued until a uniform dispersion is attained and all the binder has activated. 11.During granulation particle and agglomerates are subjected to consolidating force by action of machine parts and of intraparticulate force. 12.A rough way to determine the end point is to press a portion of mass in the palm of hand.
  14. 14. 13.The next step is wet screening process involving converting the moist mass into coarse granular aggregates by passing through hammer mill or oscillating granulator. 14.The purpose is to increase particle contact point increase surface area to facilitate drying. 15.A drying process is required in all wet granulation procedures to remove the solvent. 16.After drying the granulation is screened again. 17.Ovens employed for drying granulation wetted with explosive solvents should employ high airflow rates.
  15. 15. TABLET COATING: It is done for the following objectives 1. To mask the taste, odor or color of the drug. 2. To provide physical and chemical protection for the drug. 3. To control the release of the drug from the tablet. 4. To protect the drug from the gastric environment of the stomach with acid resistance enteric coating 5. To incorporate another drug or formula adjuvant in the coating to avoid chemical incompatibilities or to provide sequential drug release. 6. To improve the pharmaceutical elegance by use of special colors and contrasting printing.
  16. 16. TYPES OF COATING 1. Sugar Coated Tablets (SCT) 2. Film Coated Tablet (FCT) 3. Enteric Coated Tablet (ECT) 4. Compression Coating. 5. Gelatin coated tablet.
  17. 17. SUGAR COATING • Sugar coating process involves several steps, the duration of which ranges from a few hours to a few days. • A successful product depends on the skill of the coating operator. • The basic sugar coating process involves the following steps, • 1.Sealing • 2.Sub coating • 3.Syruping • 4.Finishing • 5.Polishing • Since sugar coating tends to be long and vigorous , the cores should be relatively resistance to breakage , shipping and abrasion.
  18. 18. 1. Sealing: 1. To prevent moisture penetration into the tablet core a seal coat is applied. 2. In pan ladling processes, without a seal coat, the over wetted tablets would absorb excess moisture, and affecting the physical and chemical stability. 3. Shellac is an effective sealants.
  19. 19. 2. Sub Coating: • The sub coating is applied to round the edges and build up the tablet size. • Sugar coating can increase the tablet weight by 50% to 100% • Sub coating step consists of alternately applying a sticky binder solution to the tablet followed by a dusting of sub coating powder and then drying. • Sub coating are applied until the tablet edges have been covered and the desired thickness is achieved. • The control of drying rate is critical to obtaining a rapid application of the sub coat
  20. 20. 3. Syruping (smoothing): 1. The purpose of this step is to cover and fill in the imperfections in the tablet surface caused by the sub coating step, and to impart the desired color to tablet. 2. The first syrup coats usually contain some suspended powders and are called grossing syrup. 3. Then the syrup solutions containing dye are applied until the final size and color are achieved. 4. In the final step, a few clear coats of syrup may be applied.
  21. 21. 4. Polishing and Finishing: 1. The desired luster is obtained in this final step of sugar coating. 2. The tablets can be coated in the clean standard coating pans, or canvas lined polishing pan, by carefully applying powdered wax or warm solution of these waxes in naphtha or suitable volatile solvents.
  22. 22. DEFECTS OF COATING: Variation in formulation and processing conditions may results in unacceptable quality defects in film coating. They are as follows: 1. Sticking and picking 2. Roughness 3. Orange peel effects 4. Bridging and filling 5. Blistering 6. Hazing/Dull film 7. Color variation 8. Cracking
  24. 24. 1] Roughness 1. A rough or gritty surface is defect often observed in spray type. 2. Some of the droplets may dry too rapidly, resulting in particle deposition on the surface which leads to roughness. 3. Moving the nozzle closer to the tablet or reducing the degree of automization can decrease the roughness due to spray drying.
  25. 25. 2] Blistering: • When a coated tablet require further drying in oven, too rapid evaporation of the solvent from the core and the effect of high temperature on the strength, elasticity and adhesion of the film may result in blistering. 3]Sticking and picking 1. Over wetting or excessive film tackiness causes tablets to stick to each other or to the coating pan. 2. On drying, a piece of the film may remain adhered to the pan or another tablet. 3. A reduction in the liquid application rate or increase in the drying air temperature and air volume usually solves this problem.
  26. 26. 4] Orange Peel effects: • Inadequate spreading of the coating solution before drying causes a bumpy or orange peel effect on the coating. • This indicates that spreading is impeded by too rapid drying or by high solution viscosity. • Thinning the solution with addition solvent may correct this problem.
  27. 27. 5] Color Variation: 1. This problem can be caused by processing conditions or the formulation. 2. Improper mixing, uneven spray pattern and insufficient coating may result in color variation. 3. The migration of soluble dyes, plasticizers and other additives during drying, may gives the coating a mottled or spotted appearance. 4. The use of lake dyes eliminates the dye migration.
  28. 28. 6] Cracking: 1. Cracking occurs if internal stresses in the film exceed the tensile strength of the film. 2. The tensile strength of the film can be increased by using higher molecular weight polymers or polymer blends.
  29. 29. QUALITY CONTROL TEST • This test is run to monitor the process including test for tablet weight, weight variation, hardness, thickness, disintegration etc • The data supplied by the formulator is usually employed by quality control personnel to establish the test limits. • The quality control tests for tablets are: 1. General appearance 2. Size and shape 3. Hardness 4. Organoleptic properties 5. Friability 6. Drug content and release 7. Weight variation 8. Content uniformity 9. Disintegration 10. Dissolution
  30. 30. THANKYOU