Pharma Blog
How do We Ensure that Split Tablets Maintain Dose Accuracy and Stability?
For those who need flexible dosing, tablet splitting (for tablets with a functional score-line) can be helpful, but it’s essential to ensure each piece is consistent and effective. Here’s a quick look at the *key tests and acceptance criteria to assess splitting of scored immediate-release tablets. To ensure quality and ... Read More
How Glassware Could Be Sabotaging Your Dissolution Results?
We often assume that inconsistent or low drug release during dissolution testing to product performance issues or instability of the drug at a certain pH. But here’s the twist—sometimes the problem isn’t the drug or the formulation at all. The real culprit could be the glassware you’re using during the ... Read More
Food-Drug Interactions on Drug Safety & Efficacy
The FDA’s guidance Assessing the Effects of Food on Drugs in INDs and NDAs- Clinical Pharmacology Considerations, emphasizes the importance of Food-Effect (FE) studies in assessing how food influences the absorption, safety, and effectiveness of orally administered drugs during drug development. Here’s a breakdown of key takeaways: Why Food Effects ... Read More
Troubleshooting Guide for Semisolid Dosage Forms | Part-6
In semi-solid dosage forms such as creams, ointments, gels, and pastes, maintaining the stability of color and odor is crucial for product quality, safety, and patient acceptance. Causes of Color or Odor Changes Oxidation pH Changes Degradation of Active Ingredients Interaction Between Ingredients Microbial Contamination Light Exposure Temperature Fluctuations These ... Read More
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