Pharma Digest
Troubleshooting Guide for Semisolid Dosage Forms | Part-5
Inadequate Drug Release Inadequate drug release in semi-solid dosage forms, such as creams, ointments, or gels, can significantly compromise the therapeutic efficacy of the product. Achieving the correct release profile is crucial for ensuring the desired pharmacological effect. Understanding the causes of inadequate drug release and addressing them through formulation ... Read More
Troubleshooting Guide for Semisolid Dosage Forms | Part-4
Viscosity Changes Over Time in Semi-Solid Dosage Forms Viscosity, the thickness or flow resistance of a semi-solid dosage form, plays a critical role in the product’s performance and user experience. Over time, changes in viscosity can affect drug release, reduce efficacy, or cause instability. Understanding the causes of viscosity shifts ... Read More
Troubleshooting Guide for Semisolid Dosage Forms | Part-3
Poor Stability in Semi-Solid Dosage Forms Stability is a critical factor in semi-solid dosage forms such as creams, ointments, and gels. Poor stability can lead to the degradation of the formulation, reduced efficacy, and potential harm to users. Understanding the causes and implementing appropriate solutions is essential for maintaining the ... Read More
Troubleshooting Guide for Semisolid Dosage Forms | Part-2
Phase Separation of Semi-Solid Dosage Forms What is Phase Separation? Phase separation in semi-solid dosage forms occurs when the components of a formulation, which are intended to remain uniformly mixed, separate into distinct layers or phases. This disruption often leads to a product that no longer maintains its intended consistency, ... Read More
Troubleshooting Guide for Semisolid Dosage Forms | Part-1
Are you ready to tackle some troubleshooting in semisolid dosage form manufacturing? As we gear up for the semifinal production stages, we must have a solid understanding of potential issues that may arise in the manufacturing process of semisolid dosage forms such as creams, ointments, and gels. From formulation challenges ... Read More
Oral Vs Parenteral Dosage Form | Formulation Challenges
Oral dosage form formulation challenges A) Poor Bioavailability Many drugs face challenges in being absorbed through the gastrointestinal (GI) tract due to poor solubility, gastrointestinal pH, or presence of enzymes that degrade the drug before it can be absorbed into the bloodstream. B) Solubility and Stability 1) solubility: Drugs with ... Read More
Effective Artwork Management in Pharmaceutical Industry
In this post, we’ll shift our focus from formulation to a crucial topic: Artwork Management in Pharma. In the pharmaceutical industry, managing artwork for product packaging is essential to ensure compliance, accuracy, and maintaining the brand’s standards. Here’s a detailed look at the process: Initiating the Artwork Request The process ... Read More
Role of QA in New Drug Development and Approval
Introduction The development and approval of new drugs involve a complex process, requiring rigorous quality assurance (QA) measures. QA plays a vital role in ensuring the safety, efficacy, and compliance of new drugs. In this blog, we’ll explore the critical role of QA in new drug development and approval. Why ... Read More
Optimizing Particle Size Distribution (PSD) for Tablet Formulations
Particle Size Distribution (PSD) is a key factor that influences tablet performance, especially when it comes to “disintegration” and “dissolution rates”. Here’s how PSD optimization can benefit different types of formulations: Immediate-Release Tablets Controlled-Release Tablets Poorly Soluble Drugs Direct Compression Tablets Effervescent Tablets Optimizing PSD is essential for tailoring the ... Read More
Handling Customer Complaints in Pharmaceutical Industry
Introduction Customer complaints are critical events in the pharmaceutical industry, requiring prompt attention and resolution. Effective complaint handling ensures patient safety, maintains regulatory compliance, and upholds company reputation. In this blog, we’ll explore best practices for handling customer complaints in pharmaceutical QA. Key Principles Regulatory Requirements Complaint Handling Process Best ... Read More
Validation of ERP System
Enterprise Resource Planning (ERP) system validation is essential in regulated industries, particularly pharmaceuticals, biotechnology, and medical devices, where ERP systems manage key operations like inventory, production, quality control, and distribution. Requirements Gathering User Requirements Specification (URS): Document what the users need from the ERP system, including both functional (what the ... Read More