Buffered Isotonic Solutions are specially formulated liquids that match the osmotic pressure of the body’s natural fluids, such as blood and tears. Additionally, they incorporate buffering systems to maintain a stable pH environment. These solutions are crucial in pharmaceutical applications to ensure that when administered—whether through ophthalmic (eye) or intravenous (IV) routes—they are both compatible … Read more
Applications of Buffers are solutions that resist changes in pH upon addition of small amounts of acids or bases. Importance Applications of Buffers Chemical Reactions: Many reactions are pH-dependent; buffers maintain optimal pH for maximum efficiency. Biological Systems: Enzyme activities and metabolic processes require specific pH conditions. Pharmaceutical Formulations: Drug stability and solubility can be … Read more
Definition of Buffers They are temporary memory storage areas that hold data while it is being transferred between two locations or processes. Buffer Solution: A system that minimizes changes in pH when small amounts of acid or base are added. Components: Weak Acid and its Conjugate Base (e.g., acetic acid and sodium acetate). Weak Base and … Read more
Accurate pH Determination measurement is essential in laboratories, industry, and research. 1. Electrometric Methods of pH Determination Principle: Based on the measurement of the electromotive force (EMF) of a galvanic cell that includes a pH-sensitive electrode. Components: Glass Electrode: Sensitive to hydrogen ion activity; develops a potential proportional to pH. Reference Electrode: Provides a constant … Read more
Definition of pH pH is a numerical scale used to specify the acidity or alkalinity of an aqueous solution. It is defined as the negative base-10 logarithm of the activity (concentration) of hydrogen ions (H⁺): $\text{pH} = -\log_{10}[\text{H}^+]$ Hydrogen ion concentration ([H⁺]) is measured in moles per liter (mol/L). pH Scale The pH scale typically … Read more
To fully understand Section 3 of the Act, one must be familiar with the definitions it provides: Key Definitions (Section 3 of the Act): Drug: Includes medicines for humans or animals used for diagnosis, treatment, prevention of diseases, or affecting body structure/function. Cosmetic: Articles for cleansing, beautifying, or altering appearance, including components of such products. … Read more
This topic explains the legal provisions for obtaining loan license and repacking license under Indian drug regulations and their specific requirements. The Act provides provisions for Loan Licenses and Repacking Licenses to enhance flexibility and efficiency in drug manufacturing and distribution. Loan License A Loan License allows a license holder to permit another entity to … Read more
Legal Definitions of Schedules under the Drugs and Cosmetics Rules, 1945, framed under the Act and Rules, are divided into various Schedules that specify requirements related to drugs and cosmetics. Some important Schedules include: Schedule C and C(1) Pertains to biological and special products like sera, vaccines, insulin, and other biological products. They have stricter … Read more
Study of Physicochemical Characteristics of Drug Substances Study of physicochemical characteristics of drug substances involves analyzing solubility, pKa, stability, and other properties of drug. These characteristics influence the drug’s behavior during formulation, processing, and storage, as well as its bioavailability and therapeutic performance. Key Physicochemical Characteristics of Drugs: Physical Properties: Physical form (crystalline vs. amorphous) … Read more
The primary goals and objectives of Pre-formulation studies are: Understand the Drug’s Characteristics: To determine the physical and chemical properties of the drug substance. To understand how these properties influence the drug’s performance, stability, and compatibility. Support Formulation Development: To guide the selection of excipients, processes, and packaging materials for dosage form development. To identify … Read more
