Pharma Digest
Media and Buffers in Dissolution Method Development
Sink Conditions: Volume of medium should be at least 3 times that needed to form a saturated solution (USP definition). pH Range: Typical range is 1.1 to 6.8, but can be adjusted up to pH 8.0 for solubility. Common Buffers: Surfactants: Medium Deaeration: Ensure medium is deaerated to prevent bubbles, ... Read More
Powder Shape and Their Effect on Tablet Properties
The pharmaceutical industry relies heavily on powders for the formulation of solid dosage forms, particularly tablets. Powder properties, including particle size and shape, directly affect the manufacturing process and the performance of the final product. While particle size has been extensively studied, the influence of particle shape has garnered increasing ... Read More
Does an F2 Similarity Value of 50 Mean the Two Dissolution Profiles are Only 50% Similar?
No, the similarity factor (F2) is a mathematical representation of the quadratic mean difference between two dissolution profiles across all considered time points. An F2 value of 50 indicates that the two profiles differ by a small margin, with a mean difference of approximately 10%. The similarity factor is not ... Read More
Mind Mapping Tool for Investigations
Mind mapping can be an incredibly effective tool in pharmaceutical investigations, helping teams structure their thinking, uncover connections, and generate insights systematically. Here’s how it can be applied effectively: Applications of Mind Mapping in Pharmaceutical Investigations Root Cause Analysis: During investigations of deviations, out-of-specification (OOS) results, or adverse events, mind ... Read More
Discriminating Dissolution Media
Discriminating Dissolution Media is a critical component in pharmaceutical formulation development, designed to identify differences in the dissolution performance of drug products. These media are particularly useful when addressing formulation changes, variations in API properties, or manufacturing process alterations. Key Features of a Discriminating Dissolution Medium Examples of Common Discriminating ... Read More
Key Considerations for Generic Formulation Development
Generic formulation development is a complex process designed to create bioequivalent, cost-effective alternatives to innovator products while meeting regulatory standards. Below are the critical aspects to consider: Regulatory Compliance Ensure adherence to market-specific regulatory guidelines, such as those of USFDA, EMA, or MHRA, to obtain approval for generic products. Bioequivalence ... Read More
Concepts of Elimination Rate and Clearance of Drugs
Have we come across a presenter who commented that the ‘clearance rate of a drug is high or low’? A question arises: Is clearance an elimination rate of a given drug? Some of us remain unclear regarding the concepts of elimination rate and clearance of drugs. Elimination rate is the ... Read More
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