Introduction Stability testing forms the backbone of pharmaceutical product development, ensuring that drug substances and drug products maintain their intended physical, chemical, biological, and microbiological properties throughout the proposed shelf life. The primary objective of stability testing is to furnish evidence on how the quality of a drug substance or product varies with time under…
1. Introduction to ICH and QSEM The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays an indispensable role in the global pharmaceutical landscape. Formed in 1990, the ICH emerged from the necessity to bring regulatory authorities and pharmaceutical industry stakeholders together to harmonize the scientific and technical aspects of…
1. Introduction The pharmaceutical industry is one of the most regulated industries worldwide. Medicines and medical products must be safe, effective, and of high quality before reaching the public. To achieve these goals across diverse regions and regulatory frameworks, a unified approach to drug development and approval is essential. Historically, drug manufacturers had to fulfill…
Aim: Determination of the alcohol content of Asava and Arista. References Principle Asava and Arista are self-generated alcoholic preparations obtained by the fermentation of herbal decoctions or infusions. The alcohol present is volatile, and when distilled, it passes over with water vapor. The distillate is collected and its specific gravity is determined using a pycnometer…
Aim: To perform preliminary phytochemical screening of crude drugs. References Objective Principle Crude plant materials contain diverse secondary metabolites such as alkaloids, glycosides, tannins, saponins, flavonoids, and terpenoids. Each class of compound reacts with specific reagents to yield characteristic color changes or precipitates, allowing qualitative identification of these phytochemicals. Materials Required Chemicals and Reagents Group…
Introduction to Autacoids The word autacoid originates from the Greek words “autos” (self) and “akos” (remedy or healing). Literally, autacoids mean “self-remedy” or “self-healing” substances. In pharmacology, autacoids are defined as biologically active chemical substances produced by the body that exert local effects, generally close to the site of their synthesis, and are subsequently metabolized…
1. Production Procedure 1.1 Formulation Development The production of parenteral products begins with formulation development, where the active pharmaceutical ingredient is carefully selected along with appropriate excipients and a vehicle, typically Water for Injectixon. Excipients such as buffers, stabilizers, tonicity adjusters, and preservatives are incorporated to maintain solution stability, control pH, ensure isotonicity, and prevent…
Parenteral products are sterile preparations intended for administration by injection, infusion, or implantation into the human or animal body. Unlike oral formulations, they bypass the gastrointestinal tract and enter directly into the systemic circulation or localized tissues. Because of this, sterility, pyrogen-free status, particulate-free nature, isotonicity, and safety are critical quality attributes. Parenterals are broadly…
1. Preformulation Factors Preformulation is the initial phase in the development of a pharmaceutical dosage form, where the physical and chemical properties of the drug substance are studied to design a stable, safe, and effective formulation. In parenteral products, preformulation is especially critical due to the sterile nature and direct entry into systemic circulation. Key…
Parenteral products are sterile pharmaceutical preparations intended for administration by injection, infusion, or implantation into the body. These products bypass the gastrointestinal tract, making them essential for patients who cannot take medications orally due to various medical conditions. The term “parenteral” is derived from the Greek words para (beside) and enteron (intestine), meaning that the…
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