Tag: solid oral dosage forms

Problems with establishing acceptance criteria for cleaning validation studies.

April 26, 2025 Admin

Problems with establishing acceptance criteria for cleaning validation studies. Problems with Establishing Acceptance Criteria for Cleaning Validation Studies Introduction: In the pharmaceutical industry, maintaining cleanliness and preventing cross-contamination are paramount to ensuring product safety and efficacy. Cleaning validation studies are critical components of Good Manufacturing Practice (GMP) compliance. They confirm that cleaning processes consistently produce…

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

Difficulty in evaluating the stability of multi-particulate capsules.

April 23, 2025 Admin

Difficulty in evaluating the stability of multi-particulate capsules. Difficulty in evaluating the stability of multi-particulate capsules Introduction: In the pharmaceutical industry, ensuring the stability of drug products is crucial for maintaining their efficacy, safety, and quality over their shelf life. Multi-particulate capsules, which contain numerous small, discrete particles within a single dosage form, offer several…

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

Poor reproducibility in rinse sampling data for lipid-based formulations.

April 17, 2025 Admin

Poor reproducibility in rinse sampling data for lipid-based formulations. Poor reproducibility in rinse sampling data for lipid-based formulations. Introduction: Lipid-based formulations have gained significant attention in the pharmaceutical industry due to their ability to enhance the bioavailability of poorly water-soluble drugs. However, ensuring the cleanliness of manufacturing equipment used for these formulations poses unique challenges,…

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

Inadequate systems for monitoring capsule release profiles.

April 17, 2025 Admin

Inadequate systems for monitoring capsule release profiles. Inadequate systems for monitoring capsule release profiles. Introduction: The pharmaceutical industry is a cornerstone of modern healthcare, where ensuring the efficacy and safety of medications is paramount. Solid oral dosage forms, particularly capsules, play a significant role due to their convenience and patient compliance. However, the inadequacy of…

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

Inadequate validation of capsule performance under freezing conditions.

April 16, 2025 Admin

Inadequate validation of capsule performance under freezing conditions. Inadequate validation of capsule performance under freezing conditions Introduction: In the pharmaceutical industry, solid oral dosage forms like capsules are a popular choice due to their convenience, stability, and patient compliance. However, the performance of capsules under various environmental conditions, especially freezing conditions, can be a significant…

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

Problems with testing capsules containing high API load.

April 13, 2025 Admin

Problems with testing capsules containing high API load. Problems with testing capsules containing high API load. Introduction: In the pharmaceutical industry, capsules are a popular solid oral dosage form due to their versatility and ease of administration. As the demand for high-dose medications increases, the challenge of creating capsules with a high Active Pharmaceutical Ingredient…

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

Problems with maintaining consistent dissolution profiles over the product’s shelf life.

April 13, 2025 Admin

Problems with maintaining consistent dissolution profiles over the product’s shelf life. Problems with maintaining consistent dissolution profiles over the product’s shelf life. Introduction: The dissolution profile of a pharmaceutical product is a critical parameter that impacts its efficacy and safety. Consistency in dissolution profiles over the product’s shelf life ensures that the drug is released…

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

Difficulty in monitoring the weight of individual capsule packs.

April 12, 2025 Admin

Difficulty in monitoring the weight of individual capsule packs. Difficulty in Monitoring the Weight of Individual Capsule Packs Introduction: In the pharmaceutical industry, ensuring the correct weight of individual capsule packs is crucial for maintaining quality control, regulatory compliance, and patient safety. Capsules, whether hard or soft gelatin, are a popular form of solid oral…

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

Poor validation of analytical methods for multi-drug capsule formulations.

April 3, 2025 Admin

Poor validation of analytical methods for multi-drug capsule formulations. Poor validation of analytical methods for multi-drug capsule formulations. Introduction: In the pharmaceutical industry, the development of multi-drug capsule formulations is a sophisticated process that requires precision and accuracy. The validation of analytical methods for these formulations is crucial as it ensures the quality, efficacy, and…

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

Difficulty in validating capsule drying processes for dual-layer capsules.

April 2, 2025 Admin

Difficulty in validating capsule drying processes for dual-layer capsules. Difficulty in validating capsule drying processes for dual-layer capsules Introduction: The pharmaceutical industry is constantly evolving, with innovations aimed at improving drug delivery systems and enhancing patient compliance. One such innovation is the development of dual-layer capsules. These capsules offer the advantage of delivering multiple drugs…

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

Inadequate methods for detecting trace levels of insoluble residues.

April 1, 2025 Admin

Inadequate methods for detecting trace levels of insoluble residues. Inadequate Methods for Detecting Trace Levels of Insoluble Residues Introduction: In the pharmaceutical industry, the integrity and purity of drug products are paramount. Particularly with solid oral dosage forms, such as capsules, ensuring that no insoluble residues remain is critical for both efficacy and patient safety….

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

Problems with ensuring consistent alignment of capsule cap and body parts during validation.

March 21, 2025 Admin

Problems with ensuring consistent alignment of capsule cap and body parts during validation. Problems with ensuring consistent alignment of capsule cap and body parts during validation. Introduction: In the pharmaceutical industry, the production of solid oral dosage forms such as capsules requires precision and adherence to stringent quality standards. Capsules, particularly hard and soft gelatin…

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