Amorphous: A term that refers to a solid lacking a crystalline structure. Although there may be some local arrangement of atoms or molecules within an amorphous solid, there is an absence of long-range order. Examples include window glass and polystyrene. Atomic mass unit: An atomic mass unit, abbreviated as amu, is defined as one twelfth … Read more
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
A pH meter is an electronic device used for measuring the pH (acidity or alkalinity) of a liquid (though special probes are sometimes used to measure the pH of semi-solid substances). A typical pH meter consists of a special measuring probe (a glass electrode) connected to an electronic meter that measures and displays the pH … Read more
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
Forming Temperature: The quality of the pockets that form is determined by the forming temperature. It depends on the type of packaging material and the unit’s dimensions. Sealing Temperature: It establishes the outcomes of the leak test. Pressure and plate knurling are both involved. Speed of machine: It varies from machine to machine and is determined by: i) Product Features: Size, Hardness, Shape, and Dispersible Tablets. b) According to the kind of packing materials that are utilized. Pressure: It influences product quality and can be used for cold forming and blister sealing. Leak Test: Leak test is performed to assess the possibilities of leaks in the blister and all blisters after checking should not contain water inside any pocket. Common Issues in Blister packing:
What exactly is a Blister Pack? Blister packaging is a process that entails shaping a heat-softened plastic film into deep-drawn pocket molds to create a tray (thermoforming), followed by filling it with a solid dosage form product and sealing it with either a push-through or peelable cover. Adequate heat and pressure must be applied to … Read more
The following factors are used to choose an auditor for vendor qualification: 1. Experience and Qualifications: 2. Technical Proficiency: 3. Auditing Proficiency: 4. Self-reliance and impartiality: 5. References and Reputation: 6. Adherence to Regulatory Mandates: 7. Audit Methodology and Approach: Organizations can choose a skilled auditor to assess vendors and guarantee adherence to industry standards and legal obligations by taking these factors into account.
“Good Laboratory Practice (GLP) is concerned with the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported.” GLP prescribes a laboratory to work according to a system of procedures and protocols. This implies the organization of the activities and the conditions under which these take place are controlled, … Read more
