BP702T. INDUSTRIAL PHARMACY-II (Theory)

Unit-I

Preformulation Studies:

• Introduction to preformulation studies.
• Study of physicochemical properties of drug substances:
• Solubility, partition coefficient, polymorphism, and hygroscopicity.
• pKa determination and its relevance.
• Compatibility studies with excipients.

Unit-II

Formulation Development:

• Principles of dosage form design.
• Solid Dosage Forms:
• Tablet formulation and evaluation, granulation techniques (wet, dry, and direct compression).
• Coating techniques: Sugar, film, and enteric coating.
• Liquid Dosage Forms:
• Types, formulation considerations, and evaluation parameters.
• Semi-Solid Dosage Forms:
• Ointments, creams, gels, and pastes.

Unit-III

Good Manufacturing Practices (GMP):

• Objectives and guidelines as per regulatory authorities.
• Plant layout and design considerations.
• Environmental control in pharmaceutical manufacturing.

Unit-IV

Quality Control and Quality Assurance:

• Concept and importance.
• In-process quality control (IPQC) tests for tablets, capsules, and liquid formulations.
• Finished product testing.

Unit-V

Recent Advances in Pharmaceutical Manufacturing:

• Novel Drug Delivery Systems:
• Transdermal, buccal, and gastro-retentive systems.
• Continuous Manufacturing:
• Principles and applications in modern pharmaceutical production.
• Pharmaceutical Automation:
• Robotics and automated systems for manufacturing and packaging.