Pharma Blog
Specific Issues for HLA Alleles
Idiosyncratic adverse drug reactions (ADRs) include examples of strong associations between genotypes and drug responses. These reactions: It is therefore recommended to collect DNA for later HLA typing in a drug developmental program to identify possible useful predictive HLA biomarkers. A comprehensive database listing ADRs associated with the HLA alleles ... Read More
Phenotype and Genotype Correlations
Genetic variants may influence the function of a gene: The PK-phenotype can also be determined by multiple variations in different alleles, e.g. for medicinal products metabolized by multiple pathways. The detection of specific genetic variants in clinical routine helps to improve efficacy and safety of specific medicinal products in use, ... Read More
Common and Rare Genetic Variants
A genetic variant is defined as an allele carrying variation(s) as compared to the gene reference sequence. The term variant is preferably being used instead of the term mutation, which is reserved for rare variants (<1% frequency). Furthermore, the term polymorphism defined as variations having >1 % frequency in the ... Read More
pH Sensitivity in Liquid Oral Dosage Forms
When developing liquid oral dosage forms, one critical consideration is pH sensitivity—the impact of pH on the stability, solubility, and bioavailability of active pharmaceutical ingredients (APIs). This factor can make or break the formulation process and ultimately determine the drug’s efficacy and safety for patients. During preformulation, it’s essential to: ... Read More
Temperature Sensitivity in Liquid Dosage Form Development
In the development of liquid oral dosage forms, temperature sensitivity is a critical factor that impacts solubility, stability, and overall performance. Preformulation studies help us understand how temperature fluctuations can affect the formulation, ensuring that the drug maintains efficacy and safety under various conditions. Key considerations include:Solubility & Dissolution: Temperature ... Read More
Excipient Compatibility in Liquid Oral Dosage Form
In the development of liquid oral dosage forms, “excipient compatibility” is essential to ensure the stability, efficacy, and safety of the final product. The choice of excipients plays a pivotal role in determining how well the active pharmaceutical ingredient (API) performs, and how it interacts with other components within the ... Read More
Exploring Preformulation Studies in Liquid Oral Dosage Forms
When developing liquid oral dosage forms, preformulation studies are key to ensuring the product’s stability, efficacy, and patient compliance. These studies help identify the ideal formulation parameters, including: Solubility & Stability: Assessing the drug’s solubility in different solvents and conditions to predict shelf-life and storage needs. pH Sensitivity: Understanding the ... Read More
Invisible Discriminatory Parameter in Dissolution
It’s not rpm, it’s your dissolution specs – Q value + time point. Sceptical? Well here’s a case study that makes this obvious. In this study, dissolution was run on Progesterone 100 mg Soft gelatin capsules. Dissolution profiles of two Test batches with different API particle sizes – Test 1 ... Read More
How to Set Impurity Limits in Drug Products
Step-1: Classify the peak by origin Step-2: Map the dominant formation pathway and whether it’s avoidable Amlodipine besylate tablets example: Step-3: Apply the correct regulatory ruleset + exposure thresholds Step-4: Convert limits into analytical requirements Step-5: Link each limit to control level (control strategy) Related: Pharmaceutical Impurities Calculator Resource Person: Pearl Pereira ... Read More
Safe Impurity Limit for Pharmaceuticals
The fastest way to sabotage your own submission? Set impurity limits to “look safe” Both sides think they’re protecting the product. Sometimes both are wrong! Here’s what actually happens: Set the limit too tight – based on early data: What started as a ‘conservative’ decision now stretches your development timeline. ... Read More
Dissolution Method Validation Across Multiple Strengths
Last week I came across a LinkedIn post claiming you can validate one ‘pseudo/ worst-case strength’ because same API = same method performance. While it’s true that ‘representative’ strengths ARE used in method validation. But for dissolution, this assumption is an oversimplification to the point where it’s not correct. Why? ... Read More