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 reproducibilityâespecially 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 solventâeither aqueous or alcoholicâas this directly impacts product stability, impurity levels, granule integrity, and manufacturing scalability. Below is…
Every successful generic drug starts with one essential step â understanding the innovator. Innovator Product Testing is where science meets strategy. Before formulation begins, this stage provides a complete technical blueprint of the reference product. Here’s what it entails: 1. Physical Testing â More Than Just Dimensions We analyze the innovator tablet for: These parameters…
In generic drug development, the materials you source dictate everything downstreamâfrom formulation consistency and regulatory approval to long-term commercial viability. âYour sourcing strategy is not just a procurement exerciseâit’s a regulatory foundation.â Hereâs what a smart, compliant, and inspection-ready sourcing strategy looks like: 1. Use Only Commercial-Grade Raw Materials Why it matters? Using research-grade or…
In generic drug development, every excipient decision mattersânot just for performance, but for regulatory approval. One of the most underrated tools we have is the FDA Inactive Ingredient Database (IID). The IID isnât just a list. Itâs a strategic database that gives you regulatory confidence while selecting excipients. It contains excipients that are already approved…
