Tag: Drug development

Inadequate validation of capsule disintegration profiles for multi-particulate capsules.

April 13, 2025 Admin

Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Inadequate validation of capsule disintegration profiles for multi-particulate capsules. Introduction: In the pharmaceutical industry, the validation of capsule disintegration profiles is a critical aspect of ensuring drug efficacy and patient safety. This is particularly important for multi-particulate capsules, which can offer benefits such as improved bioavailability…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in evaluating the impact of excipient changes on capsule stability.

April 12, 2025 Admin

Difficulty in evaluating the impact of excipient changes on capsule stability. Difficulty in Evaluating the Impact of Excipient Changes on Capsule Stability Introduction: In the pharmaceutical industry, the stability of a drug product is a critical factor that influences its safety, efficacy, and shelf-life. Capsules, both hard and soft gelatin, are popular solid oral dosage…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Inadequate systems for validating capsule drying profiles for soft gelatin capsules.

April 10, 2025 Admin

Inadequate systems for validating capsule drying profiles for soft gelatin capsules. Inadequate systems for validating capsule drying profiles for soft gelatin capsules. Introduction: Soft gelatin capsules are a popular dosage form in the pharmaceutical industry due to their versatility in encapsulating a wide range of substances, including liquids, suspensions, and semi-solids. Ensuring the proper drying…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in ensuring compliance with bioequivalence requirements for capsules.

April 9, 2025 Admin

Difficulty in ensuring compliance with bioequivalence requirements for capsules. Difficulty in ensuring compliance with bioequivalence requirements for capsules. Introduction: In the pharmaceutical industry, ensuring that generic formulations are bioequivalent to their branded counterparts is crucial. Bioequivalence ensures that a generic drug releases its active ingredient into the bloodstream at the same rate and level as…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies.

April 9, 2025 Admin

Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Inadequate methods for evaluating capsule dissolution in biorelevant media during stability studies. Introduction: In the realm of pharmaceuticals, the dissolution testing of capsules is a critical parameter in ensuring the efficacy and safety of drug products. Evaluating capsule dissolution in biorelevant media during…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Challenges in validating equipment for encapsulating semi-solid formulations.

April 8, 2025 Admin

Challenges in validating equipment for encapsulating semi-solid formulations. Challenges in validating equipment for encapsulating semi-solid formulations. Introduction: In the pharmaceutical industry, the encapsulation of semi-solid formulations presents unique challenges that require precise validation to ensure product efficacy and safety. Semi-solid formulations, often used for their controlled release properties and enhanced bioavailability, demand stringent equipment validation…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Difficulty in validating capsule filling processes for powders with variable particle size.

April 7, 2025 Admin

Difficulty in validating capsule filling processes for powders with variable particle size. Difficulty in Validating Capsule Filling Processes for Powders with Variable Particle Size Introduction: In the pharmaceutical industry, capsules are one of the most common forms of solid oral dosage. They offer numerous advantages, including ease of swallowing, better taste masking, and precise dosage….

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Problems with predicting the stability of capsules containing sensitive APIs.

April 6, 2025 Admin

Problems with predicting the stability of capsules containing sensitive APIs. Problems with Predicting the Stability of Capsules Containing Sensitive APIs Introduction: In the pharmaceutical industry, ensuring the stability of drug products is paramount to maintaining efficacy and safety throughout their shelf life. Capsules, both hard and soft gelatin, are popular dosage forms due to their…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Investigating Stability of Coating Polymers Under UV Exposure

April 6, 2025 Admin

Investigating Stability of Coating Polymers Under UV Exposure Investigating Stability of Coating Polymers Under UV Exposure Introduction: The stability of coating polymers under ultraviolet (UV) exposure is a crucial aspect of pharmaceutical development, particularly for solid dosage forms like tablets. Coating polymers serve multiple functions: they protect the active pharmaceutical ingredient (API), control the release…

Solid Dosage form, Tablets

Managing Failures in Adhesion Testing During Film-Coating Validation

April 5, 2025 Admin

Managing Failures in Adhesion Testing During Film-Coating Validation Managing Failures in Adhesion Testing During Film-Coating Validation Introduction: In the pharmaceutical industry, the film-coating process is critical to the production of high-quality tablets. This process not only enhances the appearance of the tablets but also controls the release of the active ingredients, protects the core from…

Solid Dosage form, Tablets

Difficulty in ensuring compliance with capsule stability testing guidelines.

April 5, 2025 Admin

Difficulty in ensuring compliance with capsule stability testing guidelines. Difficulty in ensuring compliance with capsule stability testing guidelines. Introduction: In the pharmaceutical industry, ensuring the stability of solid oral dosage forms, particularly capsules, is crucial for maintaining the efficacy, safety, and quality of medications throughout their shelf life. Capsule stability testing serves as a fundamental…

Capsules (Hard & Soft Gelatin), Solid Oral Dosage Forms

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies

April 3, 2025 Admin

Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Troubleshooting Root Cause Analysis for Non-Adherence in Stability Studies Introduction: Stability studies are a crucial component of the pharmaceutical development process, ensuring that drug products maintain their intended quality, safety, and efficacy throughout their shelf life. Non-adherence to stability protocols can lead to significant issues, including…

Solid Dosage form, Tablets