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250 points on Tablet Formulation

The document provides a comprehensive overview of tablet dosage forms, manufacturing methods, excipients, coating types, defects, evaluation tests, and advanced drug delivery systems. It highlights various tablet types, their characteristics, and the importance of quality control in tablet formulation. Additionally, it discusses regulatory aspects, packaging considerations, and factors affecting bioavailability, emphasizing the complexity and precision required in tablet production.

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Hamza Riaz
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
2 views

250 points on Tablet Formulation

The document provides a comprehensive overview of tablet dosage forms, manufacturing methods, excipients, coating types, defects, evaluation tests, and advanced drug delivery systems. It highlights various tablet types, their characteristics, and the importance of quality control in tablet formulation. Additionally, it discusses regulatory aspects, packaging considerations, and factors affecting bioavailability, emphasizing the complexity and precision required in tablet production.

Uploaded by

Hamza Riaz
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 9

1️.

Tablet Dosage Forms (Types & Characteristics)


1. Tablets are solid dosage forms containing an active pharmaceutical ingredient (API)
with excipients.
2. Conventional (Immediate-Release) Tablets dissolve quickly in the stomach.
3. Chewable Tablets must be chewed before swallowing.
4. Effervescent Tablets dissolve in water, releasing CO₂.
5. Buccal Tablets are placed between the cheek and gum for slow absorption.
6. Sublingual Tablets dissolve under the tongue for rapid absorption.
7. Lozenges (Troches) dissolve slowly in the mouth, used for throat infections.
8. Enteric-Coated Tablets resist stomach acid, dissolving in intestines.
9. Film-Coated Tablets have a thin polymer coating for taste and stability.
10. Sustained-Release (SR) Tablets release the drug over an extended period.
11. Controlled-Release (CR) Tablets provide uniform drug release over time.
12. Modified-Release Tablets include sustained, delayed, and pulsatile release tablets.
13. Orally Disintegrating Tablets (ODTs) dissolve in the mouth without water.
14. Multi-Layered Tablets contain multiple drugs or release profiles.
15. Floating Tablets remain in the stomach for prolonged drug release.
16. Gastro-Retentive Tablets use bioadhesive polymers to adhere to the stomach lining.
17. Matrix Tablets use polymer-based matrices for controlled release.
18. Osmotic Tablets (OROS System) use osmosis for controlled drug release.
19. Compression-Coated Tablets have an inner core surrounded by a compressed outer
layer.
20. Fast-Dissolving Tablets disintegrate quickly in the saliva.

2️. Tablet Manufacturing Methods


21. Direct Compression (DC) is the simplest method, requiring free-flowing powders.
22. Wet Granulation (WG) involves mixing, granulation, drying, and compression.
23. Dry Granulation (DG) is used for moisture-sensitive drugs via slugging or roller
compaction.
24. Melt Granulation uses waxes or polymers as binders and requires heating.
25. Effervescent Tablet Manufacturing involves acid-base reactions (citric acid + sodium
bicarbonate).
26. Spray Drying is used to create porous granules.
27. Fluidized Bed Granulation provides uniform granule formation.
28. Slugging Method in dry granulation forms large compacts before milling.
29. Roller Compaction compresses powders between rollers to form granules.
30. Coating Processes include sugar coating, film coating, and enteric coating.
3️. Tablet Excipients & Their Functions
31. Excipients are inactive ingredients used to enhance tablet properties.
32. Diluents (Fillers) increase tablet bulk (e.g., Lactose, MCC, Starch).
33. Binders (Adhesives) help granule formation (e.g., PVP, Gelatin, HPMC).
34. Disintegrants facilitate tablet breakup in GI tract (e.g., Starch, Crospovidone).
35. Lubricants reduce friction during compression (e.g., Magnesium Stearate).
36. Glidants improve powder flow properties (e.g., Talc, Colloidal Silica).
37. Surfactants enhance drug solubility and wetting (e.g., SLS, Polysorbates).
38. Sweeteners improve taste for chewable tablets (e.g., Aspartame, Sucralose).
39. Colorants enhance tablet appearance (e.g., Titanium Dioxide, FD&C colors).
40. Preservatives prevent microbial growth (e.g., Methylparaben, Propylparaben).

4️. Tablet Coating & Types


41. Sugar Coating masks taste but increases tablet size.
42. Film Coating provides a thin protective layer, improving stability.
43. Enteric Coating protects drugs from stomach acid.
44. Polymer Coating is used for modified-release formulations.
45. Functional Coatings control drug release (e.g., Cellulose Acetate Phthalate).

5️. Tablet Defects & Their Causes


46. Capping – Occurs when the tablet top layer separates due to improper binder.
47. Lamination – Layers split due to rapid decompression.
48. Picking/Sticking – Excess moisture causes material to stick to punches.
49. Weight Variation – Caused by poor powder flow.
50. Mottling – Uneven tablet color distribution due to dye migration.

6️. Tablet Evaluation Tests (Quality Control)


51. Hardness Test measures tablet mechanical strength.
52. Friability Test assesses tablet resistance to breakage.
53. Disintegration Test determines the time required for tablet breakdown.
54. Dissolution Test checks drug release rate in simulated GI fluids.
55. Weight Variation Test ensures tablet uniformity.
7️. Important PPSC MCQs on Tablet Formulation
Tablet Manufacturing Methods

56. Which granulation method is best for moisture-sensitive drugs?


✅ Dry Granulation
57. Which method directly compresses powders into tablets?
✅ Direct Compression

Excipients

58. Which excipient is used as a lubricant?


✅ Magnesium Stearate
59. What is the function of Crospovidone?
✅ Disintegrant
60. Which polymer is used for enteric coating?
✅ Cellulose Acetate Phthalate

Tablet Evaluation

61. Which test measures tablet mechanical strength?


✅ Hardness Test
62. What does the Friability Test measure?
✅ Tablet resistance to breakage
63. Which test determines the time for a tablet to dissolve in GI fluids?
✅ Dissolution Test
64. What is the USP limit for weight variation in tablets?
✅ ±5% for tablets > 325 mg
65. Which coating masks the unpleasant taste of a drug?
✅ Film Coating

8️. Additional Key Points for PPSC


66. Tablet thickness is measured using a vernier caliper.
67. Lubricants should not exceed 1%–2% in tablet formulation.
68. MCC (Microcrystalline Cellulose) is both a diluent and a disintegrant.
69. Sodium Starch Glycolate is a super-disintegrant.
70. Talc is a glidant but can also act as a lubricant.

71. Tablets should be uniform in weight, hardness, and appearance.


72. A tablet must be chemically and physically stable.
73. The ideal tablet should not disintegrate during handling but should do so in the
digestive system.
74. Friability should be below 1% to ensure mechanical strength.
75. Tablet weight uniformity is essential for accurate dosing.
76. Water-soluble drugs dissolve faster in the GI tract.
77. Tablets should have a smooth surface for ease of swallowing.
78. A highly porous tablet disintegrates faster due to more water penetration.
79. High binder concentration increases hardness but slows disintegration.
80. Granule particle size affects dissolution rate.

Detailed Manufacturing Process

81. Mixing (Blending) ensures uniform API distribution.


82. Granulation improves powder flow and compressibility.
83. Drying ensures stability and prevents sticking.
84. Milling (Sizing) breaks large granules into uniform sizes.
85. Lubrication ensures smooth ejection from the press.
86. Compression forms the final tablet using a punch and die.
87. Coating enhances tablet stability, taste, and drug release.
88. Packaging protects the tablets from moisture and light.
89. Storage conditions (temperature, humidity) affect stability.
90. Quality control testing is essential for batch release.

Tablet Compression Details

91. Compression force affects tablet hardness and disintegration.


92. Too little force leads to fragile tablets.
93. Too much force can cause lamination.
94. Pre-compression is used for air removal before final compression.
95. Die cavity size determines tablet weight and thickness.
96. Lower punch height affects tablet thickness.
97. Multi-tip punches are used for high-speed production.
98. Rotary tablet presses are used in large-scale production.
99. Compression speed affects uniformity and hardness.
100. Uniform compression pressure ensures dose accuracy.

Common Problems in Tablet Formulation

101. Capping is due to trapped air or improper binder.


102. Lamination occurs due to over-compression.
103. Chipping is caused by brittle formulations.
104. Weight variation results from poor flow properties.
105. Picking occurs when material sticks to punches.
106. Sticking happens due to excess moisture.
107. Double impression occurs due to free movement of the lower punch.
108. Over-lubrication causes poor compression.
109. Tablet cracking is due to rapid drying.
110. Tablet softening results from excess binder or moisture.

Tablet Coating in Detail

111. Sugar Coating requires multiple layers.


112. Film Coating is done using polymers.
113. Enteric Coating protects against gastric acid.
114. Compression Coating creates a dual-release tablet.
115. Functional coatings are used in sustained-release tablets.
116. Solvent-based coatings dry faster but are toxic.
117. Aqueous coatings are safer but take longer to dry.
118. Coating defects include orange peel, roughness, and cracking.
119. Coating solutions contain polymer, plasticizer, and solvent.
120. Coating increases tablet weight by 2-3%.

Tablet Dissolution Factors

121. Drug solubility affects release rate.


122. Disintegrant efficiency impacts dissolution.
123. Binder type influences drug release.
124. Tablet hardness affects drug availability.
125. pH-dependent solubility is crucial for weak acids and bases.
126. Hydrophilic matrix slows drug release.
127. Hydrophobic matrix retards water penetration.
128. Wet granulation improves dissolution compared to direct compression.
129. Micronized drugs dissolve faster due to higher surface area.
130. Tablet porosity enhances dissolution.

Advanced Drug Delivery Systems in Tablets

131. Osmotic pumps control drug release.


132. Hydrogel-based tablets swell for extended release.
133. Bioadhesive tablets stick to mucosal membranes.
134. Floating tablets remain in the stomach for longer action.
135. Colon-targeted tablets resist stomach and small intestine digestion.
136. Pulsatile-release tablets deliver drugs in bursts.
137. 3D-printed tablets allow precise control over drug release.
138. Nano-coating technology enhances bioavailability.
139. Layered tablets separate incompatible drugs.
140. Tablets with microencapsulation prevent drug degradation.
Regulatory Aspects of Tablet Formulation

141. USP and BP set tablet quality standards.


142. Dissolution testing follows pharmacopoeial guidelines.
143. Stability testing ensures shelf life.
144. GMP (Good Manufacturing Practices) ensures consistency.
145. ICH guidelines regulate stability studies.
146. Bioequivalence studies are required for generic tablets.
147. FDA regulates tablet labeling.
148. Tablets should meet pharmacopoeial weight variation limits.
149. Post-market surveillance monitors adverse reactions.
150. Tablet packaging must comply with drug regulatory authorities.

151. Controlled-release tablets reduce dosing frequency.


152. Matrix systems control drug release by diffusion.
153. Erosion-controlled systems dissolve over time.
154. Reservoir systems use coatings to modify release.
155. Gastro-retentive tablets increase stomach retention time.
156. pH-dependent tablets dissolve at specific pH levels.
157. Superdisintegrants improve rapid disintegration.
158. Hydrophobic lubricants may slow drug dissolution.
159. Microparticle-based tablets enhance bioavailability.
160. Mucoadhesive tablets adhere to mucous membranes.

Tablet Packaging & Stability Considerations


161. Tablets should be stored in low humidity to prevent degradation.
162. Blister packs protect tablets from moisture and air.
163. Aluminum foil is commonly used in tablet packaging.
164. Desiccants absorb moisture in tablet containers.
165. PVC (polyvinyl chloride) is a common blister pack material.
166. Tablets should be stored at 25°C in controlled conditions.
167. Photostable tablets resist light degradation.
168. Cold storage may be required for certain tablet formulations.
169. Glass bottles prevent moisture ingress better than plastic.
170. Labeling should include storage conditions and expiration date.

Granulation Process in Detail


171. Granulation improves flow properties of powders.
172. Granulation increases tablet uniformity.
173. Wet granulation involves binder addition.
174. Dry granulation avoids moisture-sensitive drugs.
175. Fluid-bed granulation dries granules rapidly.
176. Slugging produces large tablets (slugs) before milling.
177. High shear granulation provides dense granules.
178. Binder concentration affects granule strength.
179. Granule density impacts compression properties.
180. Powder blending before granulation ensures uniform API distribution.

Direct Compression (DC) Advantages & Limitations


181. DC avoids the need for granulation.
182. DC is faster and cost-effective.
183. DC requires free-flowing powders.
184. MCC is a common DC diluent.
185. DC is unsuitable for poorly compressible drugs.
186. Low-dose drugs may not distribute uniformly in DC.
187. DC results in lower tablet hardness compared to wet granulation.
188. DC requires precise powder particle size control.
189. DC tablets are more prone to weight variation.
190. DC requires fewer processing steps than granulation methods.

Coating Defects & Causes


191. Orange peel effect occurs due to high viscosity.
192. Cracking occurs when coating is too thick.
193. Peeling happens due to inadequate adhesion.
194. Twinning occurs when tablets stick together.
195. Bridging occurs when the coating fills tablet logos.
196. Chipping results from insufficient plasticizer.
197. Over-wetting leads to sticky tablets.
198. Tablet softening may occur in aqueous coatings.
199. Poor coating adhesion may result from insufficient polymer.
200. Rough coatings occur due to poor atomization.

Excipients in Sustained-Release Tablets


201. HPMC (hydroxypropyl methylcellulose) is a hydrophilic polymer.
202. Carbopol controls drug diffusion rate.
203. Ethyl cellulose is used in hydrophobic coatings.
204. Gelatin forms swelling matrices.
205. PVP (polyvinylpyrrolidone) acts as a binder.
206. Lactose is unsuitable for moisture-sensitive formulations.
207. Xanthan gum provides controlled drug release.
208. PEG (polyethylene glycol) enhances solubility.
209. Eudragit polymers are used in enteric coatings.
210. Microcrystalline cellulose is a commonly used excipient.

Tablet Testing in Pharmaceutical Industry


211. Weight variation is tested using a balance.
212. Hardness is measured using a hardness tester.
213. Friability is tested using a Roche friabilator.
214. Disintegration is tested in simulated gastric fluid.
215. Dissolution testing follows USP guidelines.
216. Moisture content is measured using Karl Fischer titration.
217. Tablet thickness is measured using a Vernier caliper.
218. Content uniformity ensures dose accuracy.
219. Stability testing assesses shelf life.
220. USP sets dissolution limits for tablet drugs.

Factors Affecting Tablet Bioavailability


221. Particle size reduction improves dissolution.
222. Solubility-enhancing agents improve absorption.
223. Hydrophobic excipients slow drug release.
224. Surfactants improve drug wetting.
225. pH influences weak acid and base drug solubility.
226. Gastric emptying time affects drug absorption.
227. Food interactions may reduce tablet efficacy.
228. Enteric coatings delay drug release.
229. Disintegrants improve dissolution rate.
230. Tablet porosity influences disintegration speed.

Pharmacokinetics of Tablets
231. Absorption depends on dissolution rate.
232. Distribution is affected by plasma protein binding.
233. Metabolism occurs mainly in the liver.
234. Excretion happens via kidneys or bile.
235. First-pass metabolism reduces bioavailability.
236. Controlled-release tablets avoid first-pass metabolism.
237. Modified-release tablets maintain steady drug levels.
238. Hydrophilic drugs dissolve quickly in plasma.
239. Lipophilic drugs cross membranes easily.
240. Drug interactions may alter bioavailability.

Tablet Innovations & Future Trends


241. 3D-printed tablets allow precise dose control.
242. Nanotechnology improves solubility.
243. Biosensors in smart tablets monitor drug release.
244. Biodegradable tablets reduce environmental impact.
245. Microneedle tablets enhance drug absorption.
246. Personalized medicine uses tailored tablet formulations.
247. Artificial intelligence optimizes formulation design.
248. Floating tablets improve gastro-retentive delivery.
249. Transdermal patches may replace some tablets.
250. Next-generation coatings provide programmable release.

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