AIChE Journal · 2003 · 61 citations · 39 references
PharmacyPharmaceuticsDosage Form DesignPharmaceutical FormulationPharmaceutical ManufacturingCapsule FormulationCapsule ManufacturingCapsule Manufacturing ProcessesDrug FormulationTablet DesignTablet FormulationDesign HeuristicsHeuristicsOperating ConditionsOptimization Of Operating ConditionsPhysical ModelsQuality FactorsTablet Manufacturing ProcessTablets
Design heuristics and physical models are offered to guide decision‑making in tablet and capsule manufacturing. The study presents a systematic procedure for synthesizing and developing a manufacturing process for pharmaceutical tablets and capsules. The procedure identifies product quality factors, selects dosage form and excipients, designs a process flowsheet with appropriate equipment and operating conditions, and evaluates the product and process to ensure the desired quality attributes. The approach is illustrated with examples of Vitamin C, antacid, and ginseng formulations.
Abstract A systematic procedure is presented for synthesizing and developing a manufacturing process for pharmaceutical tablets and capsules. The product quality factors—functional, physical and sensorial—are first identified. The dosage form and excipients are then selected, and the process flowsheet is synthesized along with the suitable equipment and operating conditions. Finally, the product and process are evaluated to ensure that the product possesses the desired quality factors. Design heuristics and physical models are provided to assist decision‐making. Examples involving Vitamin C, antacid, and ginseng are provided to illustrate the procedure.
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