Questions and Answers
What is preformulation in drug development?
A phase of research and development in which the physical and chemical properties of a drug molecule are studied to develop a safe, effective, and stable dosage form.
Which of the following are categories of physical properties that influence dosage form design?
Crystallinity has no effect on the absorption of drugs.
False
What characterizes crystallinity?
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What defines amorphous compounds?
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Polymorphism refers to when a substance exists in more than one ______ form.
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What are the two types of polymorphs?
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What methods are used to measure particle size?
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Moisture content improves the flow properties of particles.
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What is the effect of particle size on drug release?
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Study Notes
Vision and Mission of Sinai University Pharmacy
- Sinai University College of Pharmacy aims for educational quality and research excellence.
- Focus on developing distinguished pharmacists to cater to local and regional markets.
- Commitment to environmental enhancement and effective community service.
Preformulation Studies
- Preformulation involves assessing physicochemical properties of drug molecules for dosage form design.
- Essential before formulation development to guide drug formulation strategies and ensure efficacy, safety, and stability.
Physical Properties of Drug Substances
Organoleptic Characterization
- Evaluates drugs based on sensory attributes: color, odor, texture, and taste.
Bulk Characterization
- Examines solid-state properties influencing drug processing; crucial for understanding formulation behavior.
- Key aspects include crystallinity, amorphism, polymorphism, density, and powder flow properties.
Crystallinity, Amorphism, and Polymorphism
Crystallinity
- Defined by ordered atomic or molecular arrangement; affects drug absorption and stability.
- Crystal forms: cubic, tetragonal, orthorhombic, etc.
- Crystal habit influences bulk properties and flow.
Amorphism
- Atoms or molecules are randomly arranged; higher energy state than crystalline forms.
- Greater solubility but less stability; can revert to crystalline state over time.
Polymorphism
- Occurrence of substances in multiple crystalline forms.
- Enantiotropic polymorphs: stability varies with temperature (e.g., sulfur).
- Monotropic polymorphs: consistently stable across temperature ranges (e.g., glyceryl stearate).
- Different polymorphs exhibit variations in solubility, melting point, and density.
Fine Particle Characterization
- Particle size, shape, and surface morphology significantly impact drug formulation and efficacy.
Particle Size
- Influences drug absorption, release from dosage forms, and therapeutic effectiveness.
- Measured in micrometers; techniques include optical microscopy, sedimentation, light scattering, and sieving.
Particle Shape
- Affects surface area, flow characteristics, and compaction during formulation processes.
- Spherical shapes typically provide better flow and less surface area.
Particle Surface Area
- Inversely related to particle size; smaller particles have a larger surface area.
- Maximizing surface area improves solubility and dissolution rates.
Flow Properties of Particles
- Flow characteristics are crucial for effective formulation.
- Factors affecting flow include particle size, shape, density, and moisture content.
Measurement Techniques
- Hausner’s ratio and Carr’s compressibility index assess powder flow.
- The angle of repose is also a relevant measurement for assessing flowability.
Effects on Flow Properties
- Moisture content reduces particle flow.
- Round, smooth particles enhance flow properties, while finer particles improve flow efficiency.
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Description
This quiz covers the vision and mission of Sinai University College of Pharmacy, emphasizing educational quality and research excellence. Additionally, it explores the essential aspects of preformulation studies in drug development, focusing on physicochemical properties for dosage design.
