Vehicles, Additives, and Importance of Isotonicity play a crucial role in pharmaceutical formulations by ensuring drug solubility, stability, and patient acceptability. Vehicles and Additives also help maintain osmotic balance to prevent irritation or tissue damage. Vehicles The medium in which the drug is dissolved or suspended. Common vehicles include: Water for Injection (WFI): Highly purified … Read more
Introduction to Pellets Pellets are small, free-flowing, spherical or semi-spherical solid dosage forms ranging in size from 0.5 mm to 2.0 mm. They are primarily used in the pharmaceutical industry to deliver active pharmaceutical ingredients (APIs) and exhibit excellent uniformity, flowability, and versatility. Key Features: Shape and Size: Typically spherical, though slightly oval or irregular … Read more
Definition of Parenteral Products Parenteral Products refer to pharmaceutical preparations intended for administration by routes that bypass the digestive system, primarily through injections. This includes: Intravenous (IV): Directly into a vein. Intramuscular (IM): Into a muscle. Subcutaneous (SC): Under the skin. Intradermal (ID): Into the dermis layer of the skin. Other Routes: Such as epidural, … Read more
Filling and Sealing of Ampoules, Vials, and Infusion Fluids ensure sterility and accurate dosing by using automated systems under aseptic conditions. Filling and Sealing of Ampoules are critical for patient safety and product stability. Ampoules: Washing and Sterilization Ampoules are washed (automatically or manually), depyrogenated (typically by dry heat in a depyrogenation tunnel), and transferred to … Read more
Formulation Requirements for Pellets include ensuring uniform particle size, appropriate flowability, compressibility, for optimal processing and performance. Formulation Requirements for Pellets also involve maintaining drug stability, controlling moisture content, and achieving desired drug release profiles through suitable polymers and excipients. The formulation of pellets involves careful selection of ingredients to ensure proper drug release, stability, … Read more
Packing, Storage, and Stability Testing ensure drug protection by using suitable containers and environmental controls to preserve efficacy and safety. Packing, Storage, and Stability Testing help determine a product’s shelf life by assessing its physical, chemical, and microbiological stability under various conditions. Packing: Soft gelatin capsules are packed in moisture-proof containers to prevent degradation. Common … Read more
Pelletization is the process of converting fine powders or granules into small, free-flowing, spherical units. Pelletization Process can be achieved through various techniques: Common Pelletization Techniques: Extrusion-Spheronization: The most widely used method for producing pellets. Steps: Mixing and Wet Massing: The drug and excipients are blended, and a binder solution is added to form a … Read more
Equipment for the Manufacture of Pellets involves specialized machinery for producing uniform drug-loaded spheres. It includes mixers, extruders, and spheronizers essential for granulation, shaping, and rounding processes. Equipment for the Manufacture of Pellets ensures efficiency, quality, and scalability in pharmaceutical pellet production, meeting dosage uniformity and controlled-release requirements. The choice of equipment depends on the … Read more
Applications of Soft Gelatin Capsules include delivering poorly water-soluble drugs, enhancing bioavailability, and masking unpleasant tastes and odors. Applications of Soft Gelatin Capsules extend to vitamins, omega-3 fatty acids, and herbal supplements for improved stability and absorption. It has versatile applications in various fields: Pharmaceutical Applications: Oral Drugs: For liquid or poorly water-soluble drugs. Modified … Read more
In-Process Quality test and Final Product Quality Control Tests ensure product consistency during manufacturing by monitoring critical parameters like weight, hardness, and moisture. In-Process Quality test and Final Product Quality Control Tests also verify finished product quality before release. In-Process Quality Tests: Weight Variation: Measures the consistency of capsule fill weight. Ensures uniform dosing of … Read more
