Industrial Pharmacy
When Should We Not Skip a Pilot BE Study?
In generic development, we often try to save time by skipping steps. But skipping a pilot bioequivalence (BE) study is not always a good idea. There are situations where going directly to the pivotal study can be risky. For example, if the drug is highly variable, poorly soluble, or has ... Read More
Suspension vs. Tablet | The Bioequivalence Battle
Ever wondered why the “same” drug can behave so differently in the body just because of its dosage form? When transitioning a formulation from a solid oral dosage (Tablet) to a liquid oral dosage (Suspension), the stakes for Bioequivalence (BE) are incredibly high. It’s not just about the active ingredient; ... Read More
How to Design Forced Degradation Studies?
Most Forced degradation studies are started with a generic checklist: acid, alkali, peroxide, heat, light etc. But forced degradation is not about “covering conditions.” It is about understanding how your drug product is actually likely to break down. Here’s a practical way to approach it: 𝗦𝘁𝗲𝗽 𝟭: 𝗚𝗮𝘁𝗵𝗲𝗿 𝗽𝗿𝗶𝗼𝗿 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 ... Read More
Worst-Case Product in Cleaning Validation
Product grouping is a way to reduce validation activities in sites with multiple products and processes. Products may be grouped together if they are cleaned by the same process. If a product in that group requires a more aggressive cleaning process, that product becomes the worst-case product in that group. ... 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
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