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Questions and Answers
What is the main focus of Industrial Pharmacy?
What is the main focus of Industrial Pharmacy?
- Marketing and distribution strategies
- Process technology and dosage form design (correct)
- Clinical trials and patient outcomes
- Raw material extraction and purification
Which department is responsible for overseeing the application of GMPs during manufacturing?
Which department is responsible for overseeing the application of GMPs during manufacturing?
- Production department
- R&D department
- QA department (correct)
- QC department
What is the role of the Production department in a pharmaceutical firm?
What is the role of the Production department in a pharmaceutical firm?
- Sampling and testing semi-finished and finished products
- Setting up specifications for raw materials
- Large scale manufacturing according to the formulation and procedure developed by R&D (correct)
- Optimization and scale up of formulations
Which department is involved in pre-formulation and analytical method development?
Which department is involved in pre-formulation and analytical method development?
What is the main responsibility of the QC department?
What is the main responsibility of the QC department?
What does the pharmaceutical industry aim for in terms of formulations and process technologies?
What does the pharmaceutical industry aim for in terms of formulations and process technologies?
What is the relationship between particle size and surface area?
What is the relationship between particle size and surface area?
What can high surface area indicate?
What can high surface area indicate?
How do small particles with high surface area behave?
How do small particles with high surface area behave?
What is the effect of particle size distribution and shapes on drug substances?
What is the effect of particle size distribution and shapes on drug substances?
In what state are poorly soluble drugs more readily bioavailable?
In what state are poorly soluble drugs more readily bioavailable?
How do tablets' size and shape influence drug behavior?
How do tablets' size and shape influence drug behavior?
What is the main purpose of preformulation in pharmaceutical development?
What is the main purpose of preformulation in pharmaceutical development?
What do physicochemical properties of drug candidates primarily affect?
What do physicochemical properties of drug candidates primarily affect?
Why is early characterization of physicochemical properties important in pharmaceutical development?
Why is early characterization of physicochemical properties important in pharmaceutical development?
What is the critical parameter affecting drug absorption and formulation ease?
What is the critical parameter affecting drug absorption and formulation ease?
How is a drug's solubility usually determined?
How is a drug's solubility usually determined?
What solubility range is preferable for oral delivery in a solid form?
What solubility range is preferable for oral delivery in a solid form?
What technique is used to measure water uptake?
What technique is used to measure water uptake?
How does hygroscopicity affect compression characteristics in drug development?
How does hygroscopicity affect compression characteristics in drug development?
What does polymorphism refer to in drug development?
What does polymorphism refer to in drug development?
What technique provides structural data to identify and differentiate polymorphs?
What technique provides structural data to identify and differentiate polymorphs?
What is the stable polymorph in drug development?
What is the stable polymorph in drug development?
How do amorphous materials differ from crystalline materials in drug development?
How do amorphous materials differ from crystalline materials in drug development?
What is a common strategy to increase drug solubility if the solubility is less than 1 mg mL−1?
What is a common strategy to increase drug solubility if the solubility is less than 1 mg mL−1?
What can influence the solubility of a compound?
What can influence the solubility of a compound?
What is the purpose of using the Henderson–Hasselbalch equations in preformulation characterization?
What is the purpose of using the Henderson–Hasselbalch equations in preformulation characterization?
What is the significance of knowing how a drug will distribute itself between aqueous and fatty environments in preformulation?
What is the significance of knowing how a drug will distribute itself between aqueous and fatty environments in preformulation?
What can hygroscopicity significantly alter in a substance?
What can hygroscopicity significantly alter in a substance?
What does molecular dissociation, particularly understanding acid and base behavior, affect in preformulation characterization?
What does molecular dissociation, particularly understanding acid and base behavior, affect in preformulation characterization?
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Study Notes
Pharmaceutical Preformulation Considerations
- Chemical analysis of drug content in solution is crucial for determining solubility, with methods depending on the drug's chemical nature and type of product.
- Chemical modification into salt or ester forms is a common strategy to increase drug solubility, especially if the solubility is less than 1 mg mL−1.
- The solubility of a compound is influenced by various parameters including molecular size, ionization, ionic strength, temperature, and crystal properties.
- Solubility of every new drug must be determined as a function of pH over the physiological pH.
- Solubility has several pharmaceutical applications such as obtaining a homogenous distribution of small amounts of drugs, stabilizing unstable drugs, and formulating sustained release dosage forms.
- Solubilization can enhance absorption and biological activity, improve unpleasant taste of orally administered drugs, and increase drug absorption from ointment bases and suppositories.
- Molecular dissociation, particularly understanding acid and base behavior, is crucial in preformulation characterization, as it affects solubility.
- The Henderson–Hasselbalch equations allow calculation of the extent of ionization of a drug as a function of pH, if the pKa is known.
- Modern automated instrumentation is available to determine pKa values with small amounts of drug, which is useful in preformulation where material is scarce.
- In preformulation, it is important to know how a drug will distribute itself between aqueous and fatty environments, typically using n-octanol as a simple solvent model.
- A partition coefficient for the partitioning of a solute between water and n-octanol can be determined experimentally or calculated from the chemical structure of the drug candidate.
- Hygroscopicity, the tendency of a substance to attract water, can significantly alter physicochemical properties, such as reducing flowability in wet powders.
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