10+ Formulation Scientist Interview Questions and Answers

To prepare a 10% coating solution of 100 gm, 90 gm of solvent will be required.

• To prepare a 10% coating solution, the solvent will make up 90% of the total solution.

• Therefore, for 100 gm of solution, 90 gm will be solvent and 10 gm will be the coating material.

• The quantity of solvent needed will be 90 gm.

Qbd approach involves designing and developing a formulation and process based on quality attributes and risk assessment.

• Qbd stands for Quality by Design

• It involves identifying critical quality attributes (CQAs) and critical process parameters (CPPs)

• Risk assessment is done to identify potential sources of variability and their impact on CQAs

• Formulation and process are then designed and developed to ensure consistent quality

• Example: Qbd approach for tablet formulation may invo...read more

Yes, I have worked on a product with elemental impurities and resolved the issue through thorough testing and analysis.

• Identified potential sources of elemental impurities in the product

• Conducted risk assessment to determine the impact on product quality and safety

• Developed a strategy to control and monitor elemental impurities levels

• Utilized analytical techniques such as ICP-MS to quantify elemental impurities

• Implemented appropriate measures to mitigate the presence of eleme...read more

Formulation development involves systematic steps to create a generic product, ensuring efficacy and compliance.

• 1. Define product specifications: Determine the desired dosage form, strength, and release profile.

• 2. Conduct literature review: Analyze existing formulations and patents to identify potential challenges.

• 3. Select excipients: Choose suitable inactive ingredients that enhance stability and bioavailability.

• 4. Develop preliminary formulations: Create initial prototypes...read more

Excipients required in OSD formulation include binders, disintegrants, lubricants, and fillers.

• Binders help hold the tablet together, e.g. hydroxypropyl methylcellulose

• Disintegrants help the tablet break down in the stomach, e.g. croscarmellose sodium

• Lubricants prevent the tablet from sticking to the machinery, e.g. magnesium stearate

• Fillers add bulk to the tablet, e.g. lactose monohydrate

Nitrosamine impurities are a group of chemical compounds that can form during the manufacturing process of certain drugs and are considered potentially carcinogenic.

• Nitrosamine impurities are a group of chemical compounds that can form during the manufacturing process of certain drugs.

• They are considered potentially carcinogenic and are a cause for concern in the pharmaceutical industry.

• Examples of nitrosamines include N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (...read more

IIG limits and excipients are crucial in formulation development, ensuring safety and efficacy of the final product.

• IIG limits refer to the Inactive Ingredient Guide limits set by FDA for excipients in drug products

• Excipients are inert substances added to a drug to confer a suitable consistency, form, and appearance

• Excipients can include fillers, binders, disintegrants, lubricants, preservatives, etc.

• Examples of excipients: lactose, starch, cellulose, magnesium stearate, glyc...read more

Drug development process involves discovery, preclinical testing, clinical trials, regulatory approval, and post-market surveillance.

• Discovery phase involves identifying potential drug candidates through research and testing.

• Preclinical testing assesses the safety and efficacy of the drug in animals before human trials.

• Clinical trials involve testing the drug in humans to determine safety, dosage, and effectiveness.

• Regulatory approval is obtained from agencies like FDA before...read more

Challenges faced during development include formulation stability, scalability, and regulatory compliance.

• Formulation stability: Ensuring the product remains stable over time and under various conditions.

• Scalability: Adapting the formulation for large-scale production without compromising quality.

• Regulatory compliance: Meeting the strict regulations and guidelines set by authorities.

• Cost constraints: Developing cost-effective formulations without compromising efficacy.

• Ingredi...read more

Excipients are selected based on their compatibility with the active ingredient, intended dosage form, and regulatory requirements.

• Consider the intended dosage form (e.g. tablet, capsule, injection) and the properties required for that form (e.g. flowability, compressibility, solubility)

• Evaluate the compatibility of excipients with the active ingredient and other excipients in the formulation

• Ensure regulatory compliance with guidelines such as the International Conference on ...read more