Introduction to Hard Gelatin Capsules: Definition: Capsules are solid dosage forms in which the drug substance (active pharmaceutical ingredient, API) and excipients are enclosed in a soluble container or shell. These capsules are cylindrical shells made from gelatin, designed to hold solid or semi-solid drugs. They consist of a cap and body that lock together … Read more
Introduction to Production Procedure: Production Procedure involves precise compounding, dissolution, and pH adjustment under aseptic conditions to ensure sterility and stability. Production Procedure includes sterile filtration, filling, sealing, and terminal sterilization followed by stringent quality checks to ensure safety and compliance. The production of parenteral products involves several meticulously controlled steps to ensure safety, efficacy, … Read more
Introduction to Eye Drops: Eye Drops must be isotonic, pH-balanced, and preservative-free (for sensitive use), ensuring safety and effectiveness. Eye drops are sterile liquid preparations containing the drug in a solution or suspension form. They are the most commonly used ophthalmic formulations. Components: Active Ingredient: The drug, e.g., antibiotics, anti-inflammatory agents, or antihistamines. Vehicle: Aqueous … Read more
Containers for Ophthalmic Preparations are specialized sterile containers designed to maintain product sterility, stability, and accurate dosing. Containers for Ophthalmic Preparations must be non-reactive, tamper-evident, and suitable for single or multiple use. Selecting appropriate containers is vital to ensure sterility, stability, and usability: Containers for Ophthalmic Preparation: Dropper Bottles (Low-Density Polyethylene – LDPE) Commonly used … Read more
Formulation of Sterile Powders involves designing dry, aseptic drug products for reconstitution before injection, ensuring stability and sterility. Formulation of Sterile Powders requires strict aseptic processing, suitable excipients, and lyophilization to maintain product integrity. Sterile powders are prepared by removing moisture from a solution or suspension to produce a dry product that can be reconstituted … Read more
Preformulation Factors and Essential Requirements are critical for developing stable, effective drug formulations. Preformulation Factors and Essential Requirements include physicochemical properties, solubility, stability, and compatibility, ensuring optimal dosage form design Preformulation Studies Preformulation involves the characterization of a drug’s physical and chemical properties to inform formulation development. Critical preformulation factors for parenteral products include: Solubility: Ensuring … Read more
Introduction to Labeling of Ophthalmic Preparation: Labeling of Ophthalmic Preparations involves critical details such as product name, strength, storage conditions, and sterility warnings. Labeling of Ophthalmic Preparations must also include “For external use only” and proper directions for safe patient use. Proper labeling is essential to ensure the correct usage, dosage, and safety of ophthalmic … Read more
Introduction to Evaluation of Ophthalmic Preparation: Evaluation of Ophthalmic Preparations involves testing sterility, clarity, pH, viscosity, and particulate matter to ensure safety and efficacy. Evaluation of Ophthalmic Preparations also includes assessments for drug content uniformity, particle size, and in vitro drug release behavior. Physical Evaluation: Appearance: Check for clarity, color, and absence of particulates. Viscosity: Measure … Read more
Introduction to Eye Lotions: Eye lotions are sterile aqueous solutions used to wash or irrigate the eyes. They help remove debris, chemicals, or other foreign materials. Components: Active Ingredient: Similar to ointments, can include both hydrophilic and lipophilic drugs. Emollients and Lubricants: To provide moisturizing effects. Thickeners: To achieve desired viscosity without being too thick. … Read more
Introduction to Eye Ointments: Eye ointments are semi-solid preparations intended for sustained drug release They are often used for conditions requiring prolonged drug contact, such as dry eye or infections. Components: Base: Typically, anhydrous and non-irritating (e.g., petrolatum, lanolin). Drug: Antibiotics (e.g., erythromycin), anti-inflammatory agents. Stabilizers and Preservatives: Enhance stability and prevent microbial growth. Surfactants: … Read more
