Industrial Pharmacy – B. Pharma 5th Semester PDF Notes
Scope: The Industrial Pharmacy enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.
Industrial Pharmacy Notes 5th Semester
Objectives: Upon completion of the course the student shall be able to
1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in the development of pharmaceutical dosage forms
3. Formulate solid, liquid, and semisolid dosage forms and evaluate them for their quality
Industrial Pharmacy UNIT-I
Preformulation Studies: Introduction to pre-formulation, goals, and objectives, the study of physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemization, polymerization
BCS classification of drugs & its significant
Application of pre-formulation considerations in the development of solid, liquid oral, and parenteral dosage forms and its impact on the stability of dosage forms.
Industrial Pharmacy UNIT-II
a. Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression, and processing problems. Equipment and tablet tooling.
b. Tablet coating: Types of coating, coating materials, formulation of the coating composition, methods of coating, equipment employed, and defects in the coating.
c. Quality control tests: In-process and finished product tests
Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in the pharmacopeia
Industrial Pharmacy UNIT-III
a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. Size of capsules, Filling, finishing, and special techniques of formulation of hard gelatin capsules, manufacturing defects. In-process and final product quality control tests for capsules.
b. Soft gelatin capsules: Nature of shell and capsule content, size of capsules, the importance of base adsorption and minim/gram factors, production, in-process, and final product quality control tests. Packing, storage, and stability testing of soft gelatin capsules and their applications.
Introduction, formulation requirements, pelletization process, equipment for the manufacture of pellets
Industrial Pharmacy UNIT-IV
a. Definition, types, advantages, and limitations. Preformulation factors and essential requirements, vehicles, additives, the importance of isotonicity
b. Production procedure, production facilities, and controls, aseptic processing
c. Formulation of injections, sterile powders, large volume parenteral, and lyophilized products.
d. Containers and closures selection, filling, and sealing of ampoules, vials, and infusion fluids. Quality control tests of parenteral products.
Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments, and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations
Industrial Pharmacy UNIT-V
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies.
Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing the choice of containers, legal and official requirements for containers, stability aspects of packaging materials, and quality control tests.
SOP for Analysis of Packaging Materials
Industrial Pharmacy 5th Semester Notes PDF Download
Industrial Pharmacy: An Overview of Key Aspects
Industrial pharmacy is a branch of pharmacy that focuses on the development, manufacturing, and quality control of pharmaceutical products on an industrial scale. It encompasses various aspects of the pharmaceutical industry, including pre-formulation studies, formulation development, manufacturing processes, and packaging. Let’s explore some key areas within the industrial pharmacy.
Preformulation studies are conducted to assess the physical and chemical properties of drug substances. These studies involve the characterization of drug molecules, determination of solubility, stability testing, compatibility studies with excipients, and evaluation of the drug’s physical form. Preformulation studies provide valuable insights that aid in the formulation development process.
Understanding the physical properties of pharmaceutical substances is crucial in industrial pharmacy. These properties include particle size and distribution, flowability, compressibility, melting point, and polymorphism. Industrial pharmacists analyze and optimize these physical properties to ensure efficient manufacturing processes and the desired performance of dosage forms.
The chemical properties of drug substances play a vital role in formulation development and stability. Industrial pharmacists assess chemical characteristics such as drug degradation, drug-drug interactions, pH-dependent solubility, and chemical stability under different conditions. This knowledge helps in formulating stable and effective pharmaceutical products.
Tablets are one of the most common dosage forms in the pharmaceutical industry. Industrial pharmacists are involved in developing tablet formulations, selecting suitable excipients, optimizing the manufacturing process, and ensuring tablet quality, uniformity, and stability. They also focus on factors such as dissolution rate, disintegration time, and tablet hardness.
The industrial pharmacy also deals with the formulation and manufacturing of liquid oral dosage forms, such as syrups, suspensions, and solutions. Industrial pharmacists work on solubility enhancement, flavoring, preservation, and dosage accuracy in liquid oral formulations. They ensure the stability and appropriate packaging of these products.
Capsules provide an alternative dosage form for oral administration. Industrial pharmacists are responsible for developing capsule formulations, selecting suitable capsule shells, optimizing the fill formulation, and ensuring the integrity and stability of the final product. They also address factors like disintegration and dissolution characteristics.
Pellets are small, spherical particles that offer controlled-release or multi-particulate drug delivery. Industrial pharmacists are involved in the development and manufacturing of pellet formulations. They focus on factors such as drug release kinetics, coating techniques, and optimization of the manufacturing process to achieve the desired release profile and bioavailability.
Parenteral products include injectables and infusion solutions. Industrial pharmacists play a critical role in formulating sterile dosage forms, ensuring their sterility, stability, and compatibility with the delivery system. They focus on aspects like proper aseptic techniques, container closure systems, and compatibility of drugs and excipients with the delivery device.
Ophthalmic preparations are formulated for ocular administration. Industrial pharmacists develop ophthalmic formulations, including eye drops, ointments, and gels. They address challenges such as drug solubility in tears, ocular bioavailability, and maintaining sterility and stability of the formulations.
The industrial pharmacy also extends to the formulation and development of cosmetic products. Industrial pharmacists apply their knowledge of formulation science, stability testing, and regulatory requirements to create safe and effective cosmetic formulations, including creams, lotions, and topical preparations.
Pharmaceutical aerosols are inhalable dosage forms used for respiratory conditions. Industrial pharmacists work on the development and manufacturing of aerosol formulations, including metered-dose inhalers (MDIs) and dry powder inhalers (DPIs). They focus on formulation optimization, aerosol characterization, and packaging considerations.
Packaging Materials Science:
Industrial pharmacy emphasizes the selection and evaluation of appropriate packaging materials for pharmaceutical products. Industrial pharmacists consider factors such as compatibility, protection from environmental factors, tampered evidence, and patient convenience. They also address regulatory requirements related to packaging.
Industrial Pharmacy (Practical)
1. Preformulation studies on paracetamol/aspirin/or any other drug
2. Preparation and evaluation of Paracetamol tablets
3. Preparation and evaluation of Aspirin tablets
4. Coating of tablets- film coating of tables/granules
5. Preparation and evaluation of Tetracycline capsules
6. Preparation of Calcium Gluconate injection
7. Preparation of Ascorbic Acid injection
8. Quality control test of (as per IP) marketed tablets and capsules
9. Preparation of Eye drops/ and Eye ointments
10. Preparation of Creams (cold/vanishing cream)
11. Evaluation of Glass containers (as per IP)