Tag: Capsules

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions.

May 3, 2025 Admin

Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Poor reproducibility in dissolution testing results for capsules stored under stressed conditions. Introduction: Dissolution testing is a critical quality control procedure in the pharmaceutical industry, especially for solid oral dosage forms such as capsules. It ensures that the drug releases at the intended…

Capsules (Hard & Soft Gelatin), 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 ensuring compliance with environmental protection regulations.

April 14, 2025 Admin

Difficulty in ensuring compliance with environmental protection regulations. Difficulty in Ensuring Compliance with Environmental Protection Regulations Introduction: In today’s rapidly evolving pharmaceutical industry, maintaining compliance with environmental protection regulations is more critical than ever. As global awareness of environmental issues increases, regulatory bodies have imposed stringent guidelines to ensure sustainable practices. This is particularly important…

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

High variability in documentation practices for batch records.

March 18, 2025 Admin

High variability in documentation practices for batch records. High Variability in Documentation Practices for Batch Records Introduction: In the pharmaceutical industry, maintaining precise and consistent documentation practices for batch records is critical. These records serve as the blueprint of manufacturing processes, ensuring that each batch of product meets stringent quality standards. However, high variability in…

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

Poor standardization of capsule quality specifications.

March 18, 2025 Admin

Poor standardization of capsule quality specifications. Poor standardization of capsule quality specifications. Introduction: In the pharmaceutical industry, capsules represent one of the most common solid oral dosage forms, offering a convenient and effective means of delivering medications. However, the standardization of capsule quality specifications remains a significant challenge for manufacturers. With a vast array of…

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

Poor reproducibility in recovery rates for rinse sampling validation.

March 15, 2025 Admin

Poor reproducibility in recovery rates for rinse sampling validation. Poor reproducibility in recovery rates for rinse sampling validation. Introduction: In the pharmaceutical industry, maintaining rigorous standards for cleanliness and contamination control is paramount. Rinse sampling validation is a critical component of this process, ensuring that manufacturing equipment is adequately cleaned between batches. However, achieving consistent…

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

High variability in results of content uniformity testing for low-dose drugs.

March 8, 2025 Admin

High variability in results of content uniformity testing for low-dose drugs. High Variability in Results of Content Uniformity Testing for Low-Dose Drugs Introduction: The pharmaceutical industry is tasked with the critical role of ensuring that every dose of medication administered to patients is safe, effective, and of high quality. One of the major quality control…

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

What are the advantages of using pre-formulated direct compression excipients?

August 22, 2023August 5, 2023 Admin

Advantages of Using Pre-formulated Direct Compression Excipients Pre-formulated direct compression excipients are ready-to-use blends of various excipients specifically designed for direct compression tablet manufacturing. These pre-formulated excipients offer several advantages over traditional individual excipients. Here are the key advantages of using pre-formulated direct compression excipients: 1. Simplified Formulation Development Pre-formulated excipients streamline the tablet formulation…

Tablets

How are multi-layer tablets manufactured?

August 22, 2023August 5, 2023 Admin

Manufacturing Process of Multi-Layer Tablets Multi-layer tablets are pharmaceutical tablets that consist of two or more distinct layers of different drug formulations. These layers may release the active pharmaceutical ingredients (APIs) at different rates or provide other specific functionalities, such as immediate release followed by sustained release. The manufacturing process of multi-layer tablets involves careful…

Tablets

What are the different tablet scoring techniques?

August 22, 2023August 5, 2023 Admin

Different Tablet Scoring Techniques Tablet scoring is a process used to create a groove or shallow indentation on a tablet’s surface. The scoring facilitates breaking the tablet into smaller parts, allowing patients to adjust the dose as needed. Tablet scoring is particularly useful for patients who have difficulty swallowing or need a lower dosage strength…

Tablets

How are sustained-release tablets formulated?

August 21, 2023August 5, 2023 Admin

Formulation of Sustained-Release Tablets Sustained-release tablets, also known as extended-release tablets or controlled-release tablets, are designed to release the active pharmaceutical ingredient (API) over an extended period, maintaining a steady and controlled drug release profile. The formulation of sustained-release tablets requires careful selection of excipients and incorporation of drug release mechanisms to achieve the desired…

Tablets