Pre-Formulation Studies U-1 Notes

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Pre-formulation Studies

  • Introduction to Pre-formulation
  • Goals and Objectives of Pre-formulation Studies
  • Study of Physicochemical Characteristics of Drug Substances

Physical Properties in Pre-formulation Studies

  • Physical Form: Crystalline vs. Amorphous State
  • Particle Size and Shape
  • Flow Properties
  • Solubility Profile
  • Polymorphism

Chemical Properties in Pre-formulation Studies

  • Hydrolysis
  • Oxidation
  • Reduction
  • Racemization
  • Polymerization
  • Biopharmaceutics Classification System (BCS)
  • Application of Pre-formulation Considerations in Dosage Forms

Other Units of Physical Pharmaceutics II

Unit 2
Unit 3
Unit 4
Unit 5
Industrial Pharmacy I

Other Subjects of B Pharmacy 5th Semester

Topic wise notes of:

Medicinal Chemistry II

  • Anti-Histaminic & Anti-Neoplastic Agents
  • Anti-Anginal & Diuretics
  • Anti-Arrhythmic & Anti-Hyperlipidemic Agents
  • Drugs on Endocrine System, Sexual Health, Corticosteroids
  • Anti-Diabetic & Local Anaesthetic Agents
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Secondary Metabolites in pharmacognosy & phytochemistry II

Topic wise notes of:

Pharmacognosy & Phytochemistry II

  • Metabolic Pathways and Biogenesis of Secondary Metabolites
  • Secondary Metabolites: Classification, Sources and Therapeutic Applications
  • Isolation, Identification of Key Phytoconstituents
  • Industrial Production of Essential Phytoconstituents
  • Modern Extraction Techniques
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Topic wise notes of:

Pharmacology II

  • Pharmacology of Drugs
  • Drugs on Cardiovascular & Urinary System
  • Autocoids and Related Drugs
  • Pharmacology of Drugs Acting on Endocrine System
  • Bioassay
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Pharmaceutical Jurisprudence

Topic wise notes of:

Pharmaceutical Jurisprudence

  • Drugs and Cosmetics Act, 1940 and its rules 1945
  • Regulatory Framework and Administration under Act, 1940
  • Medicinal Preparations, and Narcotic Regulations in India
  • Drug Advertisement, Animal Ethics, and Drug Price Regulation
  • Pharmaceutical Legislation, Ethics, and Legal Rights
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Pre-formulation Studies – BPharma Notes (Unit I Summary)

Pre-formulation is the first and most critical step in pharmaceutical development. It involves studying the physicochemical properties of drug substances to design safe, stable, and effective dosage forms. This unit provides an in-depth understanding of the goals and objectives of pre-formulation studies and their importance in drug formulation.

1. Physical Properties of Drug Substances

  • Physical Form: Includes crystal and amorphous forms which affect solubility and bioavailability.
  • Particle Size and Shape: These influence the drug’s dissolution rate and uniformity in formulations.
  • Flow Properties: Essential for tablet manufacturing and capsule filling.
  • Solubility Profile: Factors like pKa, pH, and partition coefficient determine drug solubility in various media.
  • Polymorphism: The existence of different crystalline forms can impact stability and efficacy.

2. Chemical Properties

  • Hydrolysis, Oxidation, Reduction: These reactions can degrade drugs, so understanding them is vital for stability.
  • Racemisation and Polymerization: These affect the drug’s therapeutic effectiveness.

3. BCS Classification

Biopharmaceutics Classification System (BCS) categorizes drugs based on their solubility and permeability, which helps predict oral absorption and guides formulation strategies.

4. Applications

Pre-formulation studies guide the design of solid, liquid oral, and parenteral dosage forms. These insights help improve the stability, safety, and performance of the final product.

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