The dissolution specification is defined by the amount (Q) of active substance that dissolves within a designated time frame, represented as a percentage of the content indicated on the product label. According to the Indian Pharmacopoeia, the dissolution specification is articulated in terms of the amount (D) of active substance that dissolves in a specified … Read more
According to the solubility and permeability of drugs, the following Biopharmaceutics Classification System (BCS) is suggested in the literature (Amidon 1995) This classification serves as a foundation for establishing in vitro dissolution specifications and also aids in predicting the probability of achieving a successful in vivo-in vitro correlation (IVIVC). The solubility of a drug is … Read more
A tablet’s strength has a significant impact on its marketing, transportation and dissolution. The mechanical strength of tablet or granules can be determined by its hardness and through friability test. A clear synthetic polymer drum with polished internal surfaces that is not susceptible to static buildup shouldbe used; it should have an internal diameter of 283 to 291 mm and a depth of 36 to 40 mm. The drum has a detachable side. A curving projection that runs from the center of the drum to the outside wall and has an inside radius of 75.5 to 85.5 mm tumbles the tablets with each rotation of the drum. A device that revolves at 25 ±1 rpm has the drum fixed to its horizontal axis. As a result, the tablets slide or roll during every rotation, landing on the drum wall or one another. Friability test procedure and Acceptance Criteria
Formulation of the coating solution: Adequate preparation of the coating solution is essential for achieving an effective coating within a reasonable timeframe. This solution is prepared in S S vessels equipped with a stirrer. Various techniques are beneficial in facilitating the prompt formulation of coating solutions: Dispersion in hot water: The coating materials remain insoluble … Read more
Water is commodiously used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, and analytical reagents. Types of Water: Raw Water: Raw water is a natural water available in the environment, such as rainwater, ground water, and water from bodies like lakes … Read more
Technology transfer is both integral and critical to drug discovery and development process for new medicinal drug products. A major decision focuses on that point where the idea or process is advanced from a research-oriented program to targeted toward commercialization. Generally, the cost of product development rises dramatically during the pilot scale-up and initial production … Read more
Alternate Vendor development for existing material shall be initiated through the Change control procedure. Supply chain / purchase team on its own or on the recommendation of Technology Transfer team / R&D / Production shall identify the vendor for existing material. Supply Chaim (SCM) / purchase Team shall initiate queries with the prospective vendors for … Read more
Blending in its simplest form is the combining of two or more materials to produce a homogeneous mixture. These materials may be any combination of particulate (solids blending) or particulate and liquid (liquid-solid blending). Normal tumble blending of free-flowing materials provides a gentle mixing action. For materials that tend to lump or for high intensity … Read more
Homogenous mixing of dry & wet powders, de-agglomeration / de-lumping of wet mass and fast dispersion of binding agent. Dust free, high free flowing dosing particles, high uniformity of granule size. AC frequency control for bottom driven Impeller Mixer with 3 or 4 blades with exclusive scrape side design and Chopper positioned to make granules. … Read more
Fluid Bed Dryers (FBD) are primarily used in almost all chemical, pharmaceutical, food, dyestuff and other process industries to dry materials by fluidization with hot and / or dehumidified air, which creates a turbulence in the wet product (not totally liquid) while flowing through it. WORKING PRINCIPLE: The atmospheric air is sucked in the dryer … Read more
