Application of Pre-formulation Considerations in Dosage Forms

• The Application of Pre-formulation Considerations in Dosage Forms helps determine drug solubility, stability, and compatibility for effective formulation.
• Proper Application of Pre-formulation Considerations in Dosage Forms ensures optimal bioavailability, patient compliance, and safety in pharmaceutical preparations.

Solid Dosage Forms: (Tablets, Capsules)

Impact on Stability:

• Particle size affects dissolution and absorption.
• Poor flow properties can result in content uniformity issues.
• Moisture-sensitive drugs may degrade; therefore, desiccants and coatings are required.
• Polymorphism must be controlled to prevent recrystallization.

Key Formulation Approaches:

• Granulation to improve flow properties.
• Addition of lubricants and binders to improve compressibility.
• Use of coating agents to protect against moisture and oxidation.

Liquid Dosage Forms: (Solutions, Suspensions, Emulsions)

Impact on Stability:

• Drugs prone to hydrolysis need pH adjustment and buffers.
• Oxidation requires antioxidants and chelating agents.
• Solubility enhancers like cosolvents or surfactants are often added.

Key Formulation Approaches:

• Use of preservatives to prevent microbial contamination.
• Selection of pH modifiers to enhance solubility and stability.
• Addition of viscosity enhancers to maintain suspension uniformity.

Parenteral Dosage Forms: (Injections, Infusions)

Impact on Stability:

• Sterility and pyrogen-free requirements are crucial.
• Hydrolysis and oxidation are significant challenges due to aqueous media.
• Physical stability (precipitation) and chemical stability must be ensured.

Key Formulation Approaches:

• Use of cryoprotectants for freeze-dried formulations.
• Incorporation of antioxidants and buffers to maintain stability.
• Use of isotonic agents to match osmolarity with biological fluids.

 

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