Tag: manufacturing process

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets

June 4, 2025 Admin

Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Addressing Non-Compliance in Process Validation for Hygroscopic Tablets Introduction: In the pharmaceutical industry, the process validation of hygroscopic tablets presents unique challenges. Hygroscopic tablets are those that have a tendency to absorb moisture from their surroundings, which can lead to significant issues in their stability, efficacy, and…

Solid Dosage form, Tablets

Resolving Brittleness in Immediate Release Tablets During Long-Term Storage

May 26, 2025 Admin

Resolving Brittleness in Immediate Release Tablets During Long-Term Storage Resolving Brittleness in Immediate Release Tablets During Long-Term Storage Introduction: Immediate release tablets are a cornerstone of pharmaceutical dosage forms, designed to disintegrate promptly after administration to ensure rapid drug release. However, maintaining their integrity during long-term storage poses significant challenges. One of the most critical…

Solid Dosage form, Tablets

Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation

April 19, 2025 Admin

Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation Ensuring Adequacy of Binder Distribution in Sustained Release Tablet Validation Introduction: In the complex world of pharmaceutical manufacturing, sustained release tablets represent a crucial advancement in medication delivery systems. These tablets offer numerous benefits, including improved patient compliance and enhanced bioavailability. However, the validation of…

Solid Dosage form, Tablets

Poor reproducibility in validation data for modified-release capsules.

April 17, 2025 Admin

Poor reproducibility in validation data for modified-release capsules. Poor reproducibility in validation data for modified-release capsules. Introduction: Modified-release capsules are pivotal in modern therapeutics, offering controlled drug delivery that improves patient compliance and therapeutic outcomes. However, ensuring the reproducibility of validation data for these formulations is crucial in maintaining their efficacy and safety. Inconsistent validation…

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

Addressing Root Cause Analysis for Failures in Weight Variation Tests

April 17, 2025 Admin

Addressing Root Cause Analysis for Failures in Weight Variation Tests Addressing Root Cause Analysis for Failures in Weight Variation Tests Introduction: In the pharmaceutical industry, ensuring the consistency and quality of solid dosage forms like tablets is paramount. One critical quality control measure is the weight variation test, which evaluates the uniformity of tablet weights…

Solid Dosage form, Tablets

Difficulty in conducting root cause analysis for capsule quality failures.

April 2, 2025 Admin

Difficulty in conducting root cause analysis for capsule quality failures. Difficulty in conducting root cause analysis for capsule quality failures. Introduction: The pharmaceutical industry is tasked with the critical responsibility of ensuring that all medicinal products are safe, effective, and of the highest quality. Capsules, both hard and soft gelatin, are among the most common…

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

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets

March 28, 2025 Admin

Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Troubleshooting Weight Variation Test Failures in Film-Coated Tablets Introduction: The pharmaceutical industry is tasked with producing high-quality, consistent, and safe medicines. Among the solid dosage forms, film-coated tablets are highly prevalent due to their ease of administration, stability, and patient compliance. Ensuring uniformity in weight is a…

Solid Dosage form, Tablets

Root Cause Analysis of Failures in Weight Uniformity Tests

March 26, 2025 Admin

Root Cause Analysis of Failures in Weight Uniformity Tests Root Cause Analysis of Failures in Weight Uniformity Tests Introduction: In the realm of pharmaceutical manufacturing, ensuring the consistency and quality of dosage forms is paramount. One of the critical quality control tests for solid dosage forms, specifically tablets, is the weight uniformity test. This test…

Solid Dosage form, Tablets

Managing Residual Solvents in Solvent-Based Coating Applications

March 26, 2025 Admin

Managing Residual Solvents in Solvent-Based Coating Applications Managing Residual Solvents in Solvent-Based Coating Applications Introduction: The use of solvent-based coatings in the pharmaceutical industry plays a crucial role in enhancing the stability, appearance, and functionality of solid dosage forms such as tablets. However, managing residual solvents in these applications is paramount to ensure the safety,…

Solid Dosage form, Tablets

Addressing Challenges in Process Validation for Immediate Release Tablets

March 24, 2025 Admin

Addressing Challenges in Process Validation for Immediate Release Tablets Addressing Challenges in Process Validation for Immediate Release Tablets Introduction: Immediate release tablets are a cornerstone in the pharmaceutical industry, known for their rapid disintegration and absorption properties, providing swift therapeutic effects. As the demand for these tablets continues to grow, ensuring their efficacy and safety…

Solid Dosage form, Tablets

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets

March 21, 2025 Admin

Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Investigating Causes of Non-Uniform Dissolution Profiles in Enteric Tablets Introduction: Enteric tablets are specially designed to withstand the acidic environment of the stomach and dissolve in the more neutral pH of the intestines. This targeted dissolution is critical for drugs that are sensitive to stomach acid…

Solid Dosage form, Tablets

Addressing Core Crumbling in Multi-Layer Tablet Compression

March 20, 2025 Admin

Addressing Core Crumbling in Multi-Layer Tablet Compression Addressing Core Crumbling in Multi-Layer Tablet Compression Introduction: The pharmaceutical industry constantly strives to improve the quality and efficacy of solid dosage forms, particularly tablets. Multi-layer tablets have gained popularity due to their ability to deliver more than one active ingredient with different release profiles. However, the manufacturing…

Solid Dosage form, Tablets