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Reservoir Monolithic
Matrix
Formulation of sustained release tablet of Diltiazem HCl using Rosin as a matrix system Proposed formula: Composition (in mg)
1. 2. 3. 4.
Ingredients Diltiazem HCl (Active) Rosin (Polymer) Talc Magnesium Stearate F1(1:1.25) 90 112.5 6 4 F2(1:1.5) 90 135 6 4 F3(1:1.75) 90 157.5 6 4
Tablet Compression
Drug (Diltiazem Hydrochloride), polymer, magnesium stearate and talc were passed through sieve no. 80 separately and then mixed properly. The matrix tablets of the above formulations were compressed in a tablet compression machine.
Data analysis
Dissolution
120 Percentage release 100 80
60
40 20 0
98.0% release was observed in 13 h for 1:1.5 and 98.0% release was observed in 16 h for 1:1.75
600 800 1000 Time (min)in 10 h for the ratio of 1:1.25, 98.0% release was observed
200
400
Performance of sustained release formulation was reported to be greatly affected by physicochemical properties of polymer
Risk Control
formulation subjected to check the effect of release enhancers like lactose, MCC, and Mannitol Composition (in mg)
1. 2. 3. 4. 5. 6. 7. Ingredients Diltiazem HCl (Active) Rosin (Polymer) Lactose MCC Mannitol Talc Magnesium Stearate F4(1:1.75) 90 157.5 37.5 9 6 F5(1:1.75) 90 157.5 37.5 9 6 F6(1:1.75) 90 157.5 37.5 9 6
Adequate stability Uniformity in composition Dose variation Cross contamination Preservation Proper packaging selection of packing material label control
Risk management throughout the life cycle of product i.e from design development, mfg, distribution with good quality assurance procedure