Industrial Pharmacy
Differences Between RSABE and Traditional ABE Approaches
Scaling of Bioequivalence Limits RSABE (reference-scaled average bioequivalence): The limits are scaled based on the intra-subject variability of the reference drug. For drugs with higher variability, the acceptance criteria are relaxed, meaning the 90% confidence interval for the pharmacokinetic parameter ratios can be wider than the standard 80–125% used in ... Read More
Highly Variable Drugs and RSABE
Highly variable drugs (HVDs) are a category within pharmaceuticals that exhibit significant intra-subject variability in pharmacokinetic parameters such as peak concentration (Cmax) and the area under the concentration-time curve (AUC). Specifically, a drug is classified as highly variable when the intra-subject variability, represented by the coefficient of variation (CV), exceeds ... Read More
Special BE Considerations for Highly Variable and Narrow Therapeutic Index Drugs
High Variability Drugs (HVDs) and Narrow Therapeutic Index Drugs (NTIDs) represent unique challenges in bioequivalence (BE) studies due to their specific pharmacokinetic characteristics. HVDs typically exhibit high intra-subject variability in drug absorption and distribution, meaning that the pharmacokinetic response can vary significantly within the same individual across different doses. Conversely, ... Read More
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
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