Formulation Development Interview Questions and Answers
Q. What do you mean by pre-formulation study?
A study conducted before the formulation development begins and aim to gather primary information about the physical and chemical properties of the drug substance, drug product and reference product (RLD).
Q. What do you mean by RLD?
RLD stands for Reference Listed Drug approved by regulatory authority (USFDA) as a reference for generic drug manufacturers.
Q. Which parameters should check during preformulation study of API?
- API solubility
- API BCS class
- API hygroscopicity
- API melting point
- API storage condition
Q. Which parameters should check during RLD characterization?
- List of excipients used in RLD
- Size and shape
- Weight
- Hardness and Thickness
- Dissolution profile
- Packaging mode
- Storage condition
Related: Difference Between RLD and RS
Q. Do you hear QTPP, CMA, CPP and CQA? Elaborate them.
Yes.
- QTPP = Quality Target Product Profile
- CMA = Critical Material Attributes.
- CPP = Critical Process Parameter.
- CQA = Critical Quality Attributes.
Q. How to set QTPP?
Based on the physicochemical properties of RLD/RS a quality target product profile (QTTP) is to be defined.
Q. What do you mean by QbD?
Quality by design (QbD) is a scientific and risk-based approach to pharmaceutical product development that begins with predefined objectives. Instead of relying on finished product testing alone, QbD ensure the product quality throughout the development process.
Related: Quality by Design (QbD) in Pharmaceutical Development
Q. Mention 3 binder name used in formulation davelopment.
- PVP K-30/90
- HPMC
- HPC
Q. Mention 3 super disintegrant name used in formulation development.
- Crospovidone
- Croscarmellose Sodium
- Sodium Strach Glycolate
Q. Mention 2 water soluble lubricant name used in formulation development?
- Sodium stearyl fumarate
- Sodium lauryl sulfate
Related: List of Pharmaceutical Excipients and Their Uses
Q. When a drug substance call highly soluble?
A drug substance is considered highly soluble when the highest strength is soluble in 250 mL or less of aqueous media over the pH range of 1-6.8.
Q, What do you mean by similarity factor (f2)?
The similarity factor (f2) is a mathematical measure used in pharmaceutical sciences to measure the similarity between two dissolution profiles (RLD and generic drug product).
If f2 is close to 100, the dissolution profiles of the two products are considered highly similar. If f2 is less than 50, the profiles are considered dissimilar.
Q. Mention few tablet problems with their reasons.
- Capping (single layer separation): air entrapment, low or very high moisture, excessive pre-pressure.
- Lamination (two or more layer separation): air entrapment, excessive fines, excessive pre-compression pressure.
- Sticking: worse punch, excessive moisture, insufficient compaction force.
- Edge erosion: particle segregation, low moisture content, poor compaction.
- Double impression: free rotation of either lower or upper punch.
Related: Common Tablet Defect and Remedies
Q. What do you mean by bioequivalence and biosimilar?
Bioequivalence refers to the similarity in the rate and extent of absorption between test product and reference (or originator) product.
Biosimilar means a biological product is similar already approved biological reference product. Biosimilars are not identical as generic drug but are highly similar in terms of structure, function, efficacy, and safety to the reference product.
Q. How to measure bioavailability of a drug product?
Bioavailability is usually measured by plasma concentration time curve (AUC) and the maximum concentration (Cmax) of a drug respectively.
Q. What do you mean by BCS class?
BCS classification system is a scientific framework to differentiate the drug substances on the basis of solubility and permeability under prescribed condition.
According to the BCS classification, drug substances are classified as follows:
- Class 1: High Solubility – High Permeability
- Class 2: Low Solubility – High Permeability
- Class 3: High Solubility – Low Permeability
- Class 4: Low Solubility – Low Permeability
Related: Online BCS Classification Database
Q. Mention the CQAs for solid oral dosage form.
- Dissolution
- Assay
- Impurities
Q. What is the purpose of GMP?
Purpose of GMP is to protect Product, Personnel and Environment.
Q. What are the name of ICH quality guidelines?
- Q1A-Q1F: Stability | Bracketing and Matrixing | Forced Degradation
- Q2: Analytical Validation
- Q3A-Q3E: Impurities | Residual Solvents
- Q4A-Q4B: Pharmacopoeias
- Q5A-Q5E: Quality of Biotechnological Products
- Q6A-Q6B: Specifications
- Q7: Good Manufacturing Practice
- Q8: Pharmaceutical Development
- Q9: Quality Risk Management
- Q10: Pharmaceutical Quality System
- Q11: Development and Manufacture of Drug Substances
- Q12: Lifecycle Management
- Q13: Continuous Manufacturing of Drug Substances and Drug Products
- Q14: Analytical Procedure Development.
Related: Difference Between ICH and USFDA Guidelines
Q. What are the ICH climate zones?
- Zone I – Temperate zone: 21̊C, 45%
- Zone II – Subtropical zone: 25̊C, 60%
- Zone III – Hot dry zone: 30̊C, 35%
- Zone IVa – Hot humid zone: 30̊C, 60%
- Zone IVb – Hot higher humid zone: 30̊C, 75%
Q. How can claim the shelf life of Pharmaceutical Product?
Depending on the stability study data we can claim the shelf life of a pharmaceutical product. When a product is physically and chemically stable for 6 months at accelerated condition (40/75) and 12 months at intermediate condition (30/65) we can claim 2 years shelf life.
Q. What is ANDA?
Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA’s center for drug evaluation and research, review and ultimate approval of generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American people.
Q. What is Generic drug?
A generic drug is a pharmaceutical equivalent to a reference drug in terms of active ingredients, dosage form, strength, route of administration, performance characteristics, and intended use.
Related: Generic Drug Development Process
Q. What is Orange book?
Orange book provides a list of drug products approved by the USFDA, along with evaluations of their therapeutic equivalence to other approved products.
Where you can search the FDA approved product by active ingredient, proprietary name, applicant, or application number.
Q. What is the significant of dissolution?
Dissolution is the process in which a substance forms a solution. Dissolution testing measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc. The dissolution of a drug is important for its bioavailability and therapeutic effectiveness.
Q. Please mention the name of USP dissolution apparatus.
- Apparatus 1 (Basket)
- Apparatus 2 (Paddle)
- Apparatus 3 (Reciprocating Cylinder)
- Apparatus 4 (Flow-Through Cell)
Q. What is HLB value?
The hydrophilic-lipophilic balance of a surfactant defining the affinity of a surfactant for water or oil. Surfactants with HLB values between 4 and 6 generally stabilize w/o emulsions whereas HLB values between 8 and 18 would stabilize o/w emulsions.
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