Parenteral Products: Production Procedure etc

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 … Read more

Parenteral Products: Production Procedure, Production etc

1. Introduction 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 … Read more

Preformulation Factors and Essential Requirements

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 … Read more

Parenteral Products: Definition, Types, Advantages, and Limitations

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 … Read more

Pellets: Introduction and Formulation

pellets

Pellets are small, free-flowing, spherical or semi-spherical solid units typically ranging from 500 to 1500 micrometers in diameter. They are formed from powders or granules of active pharmaceutical ingredients (APIs) and excipients and are designed for oral administration. Pellets can be filled into capsules, compressed into tablets, or used for controlled release, immediate release, or … Read more

Packing storage of soft gelatin capsules

Packing storage of soft gelatin capsules

Packing storage of soft gelatin capsules: Soft gelatin capsules (softgels) are widely used dosage forms for delivering liquid, semi-solid, or paste-like contents. Due to their unique composition—primarily gelatin, plasticizers, and water—these capsules are sensitive to environmental factors such as humidity, temperature, and oxygen. Therefore, proper packaging, storage, and rigorous stability testing are critical to ensure … Read more

Soft Gelatin capsules: Quality control

Soft Gelatin capsules: Quality control testing is essential in the manufacturing of soft gelatin capsules to ensure the product meets pharmacopeial specifications, maintains its integrity throughout its shelf life, and delivers the intended therapeutic effect. Quality control (QC) procedures are divided into two main phases: in-process testing and final product testing. Both phases are critical … Read more

Importance of Base Adsorption & Minim/Gram Factors

Importance of Base Adsorption

Importance of Base Adsorption: Soft gelatin capsules are widely used in pharmaceutical formulations for encapsulating liquids, semi-solids, and suspensions that are not amenable to hard gelatin capsules. The success of any soft gelatin capsule product depends not only on the active pharmaceutical ingredient (API) but also on the careful selection and handling of the excipients, … Read more

Soft Gelatin Capsules

Soft Gelatin Capsules

Soft gelatin capsules, commonly referred to as soft gels, are a popular pharmaceutical dosage form that encapsulates a liquid or semi-solid substance within a soft, flexible gelatin-based shell. These capsules are widely utilized for the oral administration of a variety of pharmaceuticals and dietary supplements, including fat-soluble vitamins, essential oils, and drugs with poor water … Read more

In process and final product quality control tests for capsules

1. In-Process Quality Control (IPQC) Tests for Capsules In-process quality control tests are performed during different stages of manufacturing to monitor the product and ensure consistency. These tests help in identifying and correcting deviations before the final product stage. 1.1 Weight Variation Test Purpose: To ensure consistent dosage of the active pharmaceutical ingredient (API) in … Read more