Pharmaceutical Excipients
Pharmaceutical Disintegrants and It’s Mechanism of Action
Croscarmellose Sodium(CCS) Crospovidone Sodium Starch Glycolate Microcrystalline Cellulose(MCC) Pre-Gelatinized Starch Low-Substituted Hydroxypropyl Cellulose(L-HPC) Ion Exchange Resins (e.g., Polacrilin Potassium) Read also:
Critical Material Attributes (CMAs) of Excipients
When focusing solely CMAs of excipients, the same principles of API apply. These attributes influence the performance and manufacturability of the final drug product and are critical for achieving consistency in pharmaceutical formulations. Critical Material Attributes of Excipients Physical Properties Particle Size Distribution (PSD): Bulk Density and Tap Density: Specific ... Read More
Coloring Agents in Pharmaceutical Industry
Coloring agents are used mainly to impart an elegant appearance, identification and protection to: Color Index Number (C.I. No.) is the identifier number of color “dye” or “lake”. Example Dyes vs Lakes Regulations 3 main sources to set specification of dyes Common Tests of Dyes Common Tests of Lakes Same ... Read More
WHO GMP Guideline for Excipients Used in Pharmaceutical Products
The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical ReportSeries No 885, 1999. As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product. ... Read More
Excipients in Pharmaceutical Applications
Pharmaceutical excipients are used in virtually all drug products and are essential for drug product manufacturing and performance. Thus, the successful manufacture of a robust product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. The intended end use of the excipient should be ... Read More