SCOPE:This course focuses on the development, manufacturing, and delivery of active pharmaceutical ingredients into effective and safe dosage forms. Through this course, students will gain an in-depth understanding of the principles of drug formulation, manufacturing processes, and quality assurance for both novel and conventional drug delivery systems .It covers formulation concepts, including particle technology, which plays a pivotal role in preformulation and formulation studies The course emphasizes the art and science of combining APIs with excipients to develop various dosage forms, such as tablets, capsules, injections, inhalations, and more.The curriculum explores techniques and equipment used for formulation development, small-scale preparation, and commercial production. It also highlights the importance of quality control measures to ensure finished products meet safety and efficacy and stability standards. The course fosters an attitude of meticulous attention to detail, encouraging students to apply theoretical knowledge to practical problem-solving in formulation development. Furthermore the course introduces novel drug delivery systems and their advantages and disadvantages. It explores the design and rationale behind modified-release dosage forms and advanced delivery platforms. The course addresses sustainability by exploring environmental aspects of propellant-free technologies, the advancement of digitalised DPIs, and the role of AI in enhancing pharmaceutical formulations and smart drug delivery within dry powder inhalation systems.Overall this course prepares students to approach the field of pharmaceutical development with an innovative outlook, fostering adaptability and continuous learning to meet the dynamic needs of the healthcare industry.COURSE LEARNING OUTCOMESUpon successful completion of the course, the student shall be able to;KNOWLEDGEK1: List different types of dosage forms and its classificationK2: Discuss the science of particle technology.K3: Describe different techniques in preparation of various formulationsK4: Explain the quality control parameters for the formulations K5: Distinguish conventional and novel drug delivery systems K6.Analyse drug degradation and stability testing parameters SKILLS1: Prepare pharmaceutical tablets and capsulesS2: Evaluate prepared tabletsS3: Perform sealing of ampoulesS4: Prepare cold cream, lipstick and shampooS5: Discuss the labelling and packaging specifications of pharmaceutical formulationsS6: Determine the expiry date of a drug using stability data.ATTITUDEA1: Participate in group discussionsA2: Appreciate all the initiatives of the institutionA3: Follow emerging trends in the field of pharmaceutical sciencesA4: Foster Critical thinkingA5: Cultivate empathy and compassionA6: Exhibit ProfessionalismCOURSE CONTENTS:UNIT I Powder Technology 2 hoursParticle size, Surface area, Derived properties of powder, porosity, packing arrangement. (1hrs)Flow property and determination. (1hrs)UNIT II Tablets 15 hours Definition,Advantages and disadvantages, Classification (4 hrs) Excipients,Processing&Granulation techniques(3 hrs) Compression and Machines, Processing problems (2 hrs) Quality control and evaluation. (3 hrs)Tablet coating Advantages, Materials, Types (1hrs) Methods,Equipments, (1hrs)Quality control tests, Processing problems(1hrs)UNIT III Capsules 7 hours Definition,Advantages and disadvantages,Types,Different sizes and shapes. (1 hrs)Raw material for capsule shell manufacturing,Capsule shell production. (2 hrs) Production and filling of hard gelatin capsules. (1 hrs)Production of soft gelatin capsules (1 hrs) Quality control tests. (2 hrs)UNIT IV Inhaled formulations 8 hours Pharmaceutical AerosolsDefinition,Advantages ,Propellants(1 hrs) Containers, Components (1 hrs)Types of aerosol systems, Aerosol Filling, Evaluation tests (2 hrs)Dry powder inhalationsFormulation of DPIs. (2 hrs) Environmental impact of inhalers (1 hr) Digitalised DPIs and smart inhalers (1 hr)UNIT V Sterile Dosage Forms 12hours ParenteralsDefinition, Types,Advantages and disadvantages, Large and small volume Parenterals,Official Preparations. (2 hrs)Formulation,Vehicles and Excipents(2 hrs)Layout , Facilities for parenteral Manufacturing area(3 hrs) Sterilisation and Quality Control tests. (3 hrs)Ophthalmic Preparations Types: Eye drops, Eye Lotions,Eye ointments ,Contact lens solutions .General formulation aspects of ophthalmic formulations. (2 hrs)UNIT VI Controlled and Novel Drug delivery Systems 4 hours Definition, Rationale and concept ofControlled drug delivery systems, Delayed, Extended and sustained drug delivery systemsTransdermal, Buccal, rectal , parenteral , implants ,ocular and nasal drug delivery systems. (4 hrs)UNIT VII Satbility studies 2 hoursPhysical and chemical factors affecting chemical degradation of pharmaceutical product. (1 hr)Accelerated stability testing in expiration dating of pharmaceutical dosage forms. (1 hr)
