BIOPHARMACEUTICS CLASSIFICATION SYSTEM

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

FRIABILITY

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

UNDERSTANDING PRE-REQUISITES FOR TECHNOLOGY TRANSFER

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

BASIC UNDERSTANDING OF DIFFERENT EQUIPMENT AND CRTICAL OPERATING PARAMETRS:

Equipment must be located, designed, constructed, adapted, and maintained to suit the operations to be carried out. The layout and design of equipment must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the … Read more

COATING PROCESS IN PHARMACEUTICAL MANUFACTURING:

UNDERSTANDING COATING: Coating can be defined as a physical deposition of a layer on Tablet surface for the purpose of masking the Taste, odour, appearance, physical / chemical protection or to control the drug release. Coating process is the application of coating composition to a moving bed of Tablets in a coating pan by concurrent … Read more

COMPRESSION PROCESS IN PHARMACEUTICAL MANUFACTURING

TABLET COMPRESSION: Reducing the bulk volume of a powder by applying mechanical force so as to form a defined shape of desired weight and strength is called ‘Compression’. Tablet compression is the process of squeezing powders together and driving out the air between the particles, resulting in a compressed Tablet. WHY COMPRESSION? TABLET PRESS OR … Read more

Unit Operations during manufacture of Tablets:

Unit Operations: The manufacture of Tablets is a complex multi-stage process under which the starting materials change their physical characteristics a number of times before the final dosage form is produced. Numerous unit operations are involved in making Tablets including sifting, mixing, granulation, drying, sizing, blending, lubrication, compression and coating. DISPENSING OF RAW MATERIALS (API … Read more

Solid Dosage Form – Tablets

TABLETS: Tablets are the solid pharmaceutical dosage forms containing drug substances with or without suitable diluents and prepared either by compression or molding methods. Advantages of Tablets: Disadvantages of Tablets: EXCIPIENTS USED IN THE MANUFACTURE OF TABLETS: In addition to the active ingredient, solid dosage forms will also contain a range of substances called excipients. … Read more

PHARMACEUTICAL DOSAGE FORMS

Pharmaceutical Dosage Forms: Dosage forms are the means by which drug molecules are delivered to sites of action within the body. The requirement for dosage forms: Classification of pharmaceutical dosage forms: Dosage forms are classified according to route of administration and physical forms. ORAL DOSAGE FORMS: SOLID DOSAGE FORMS TABLET: A tablet is a hard, … Read more