By Reynir Eyjolfsson
Design and Manufacture of Pharmaceutical Tablets bargains genuine international options and results of formula and processing demanding situations of pharmaceutical capsules. This ebook contains various functional examples relating to real formulations which have been verified and advertised and covers vital facts within the parts of balance, dissolution, bioavailibity and processing. It presents vital history and theoretical details on layout and production and contains a complete part devoted to layout experimental method and information. additionally, this booklet bargains a a normal dialogue of excipients utilized in right pill layout besides functional examples on the topic of excipients. Drug improvement scientists in and academia, in addition to scholars within the pharmaceutical sciences will enormously enjoy the sensible wisdom and case examples supplied all through this book.
- Incorporates vital mathematical types and computational applications
- Includes designated content material on imperative composite layout and augmented simplex lattice
- Provides heritage on very important layout ideas with emphasis on quality-based layout (QBD) of pharmaceutical dosage forms
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Extra info for Design and Manufacture of Pharmaceutical Tablets
4 Remarks Relatively high concentration of lubricant is necessary due to the poor compaction properties of the API. 1 Properties of active pharmaceutical ingredient White or almost white, crystalline powder. Sparingly soluble in water, freely soluble in methanol. Very unstable in solid dosage forms if no precautions are taken. Main degradants are hydrolysis (HYD) and cyclization (CYC) products. Batches with mean particle sizes, D[4,3], from 6 to 22 mm (laser light diffraction, dispersion Tegiloxan 3 + 10 s ultrasound) have been used.
Instead a formulation based on information in the literature was adopted. 2% magnesium stearate as lubricant. Granulation is performed with ethanol 96%. Trial lots having this composition furnished good quality tablets from both API-50 mm and API-10 mm. 3 × 17 mm oval) was about 150 N and disintegration time about 5 min. 4), 900 ml, paddles, 50 rpm; specification NLT 80% dissolved after 45 min]. In fact, the two formulations are not very different except for the fact that the latter contains MCC.
7% magnesium stearate using purified water as granulating liquid. Rather hard tablets with long and unacceptable disintegration times were obtained in all cases. Increasing the content of disintegrant (Polyplasdone XL-10) to 8% did not solve this problem either; the tablets (8 × 18 mm capsule shaped) obtained still disintegrated very slowly or in 12–15 min. The disintegrant had been placed intragranularly in all the formulation experiments described above. Therefore, it was determined to place half of the disintegrant along with a portion of the diluent (Avicel PH-102) extragranularly (see composition of tablets below).
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