In the development of generic oral solid dosage forms, wet granulation remains the method of choice—particularly for formulations involving low-dose actives or APIs with poor flow properties. However, the effectiveness of this method largely depends on how excipients are selected and utilized during the formulation process. Drawing insights from the Handbook of Pharmaceutical Generic Development,…
Direct Compression (DC) is one of the most efficient and widely adopted methods in tablet manufacturing due to its simplicity and minimal processing steps. However, its success relies heavily on a deep understanding of excipient functionality, powder flow properties, and blend uniformity. Step-by-Step DC Manufacturing Process 1. Excipient and API Selection 2. Initial Blending 3….
In the development of oral solid dosage forms, particularly generics, wet granulation remains one of the most reliable and scientifically justified approaches. It offers superior compressibility, flow properties, and batch reproducibility—especially when dealing with challenging APIs like Metformin and Famotidine. Formulation Case Study: Metformin and Famotidine Tablets An optimized wet granulation approach is demonstrated in…
In pharmaceutical R&D, wet granulation is a fundamental process, especially for oral solid dosage forms where flow, compressibility, or uniformity challenges exist. One of the most critical early decisions during formulation development is the choice of granulating solvent—either aqueous or alcoholic—as this directly impacts product stability, impurity levels, granule integrity, and manufacturing scalability. Below is…
Changes in equipment used for manufacturing a product can have different implications depending on the market. Regulatory authorities assess these changes based on their potential impact on product quality, safety, and efficacy. Below is a comparative view of how major markets handle equipment changes: USFDA Risk-Based Approach: Major Change (Prior Approval Supplement – PAS): If…
Transferring a formulation to a new site requires careful planning to ensure product consistency, regulatory compliance, and quality assurance. Technical Considerations Quality & Regulatory Considerations Conclusion A well-managed site transfer ensures product integrity, regulatory approval, and seamless market continuity. Read also: Resource Person: Moinuddin syed. Ph.D, PMP
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