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BP701T. INSTRUMENTAL METHODS OF ANALYSIS (Theory)

Unit -I

UV Visible spectroscopy: Electronic transitions, chromophores, auxochromes, spectral shifts,
solvent effect on absorption spectra, Beer and Lambert’s law, Derivation and deviations.
Instrumentation – Sources of radiation, wavelength selectors, sample cells, detectors-Photo tube,
Photomultiplier tube, Photo voltaic cell, Silicon Photodiode.
Applications– Spectrophotometric titrations, Single component and multi component analysis.
Fluorimetry: Theory, Concepts of singlet, doublet and triplet electronic states, internal and
external conversions, factors affecting fluorescence, quenching, instrumentation and
applications.

Unit-II

IR spectroscopy: Introduction, fundamental modes of vibrations in poly atomic molecules,
sample handling, factors affecting vibrations.
Instrumentation– Sources of radiation, wavelength selectors, detectors – Golay cell,
Bolometer, Thermocouple, Thermister, Pyroelectric detector and applications.
Flame Photometry– Principle, interferences, instrumentation and applications.
Atomic absorption spectroscopy– Principle, interferences, instrumentation and applications.
Nephelo-turbidimetry– Principle, instrumentation and applications.

Unit-III

Introduction to chromatography:
Adsorption and partition column chromatography- Methodology, advantages, disadvantages
and applications.
Thin layer chromatography– Introduction, Principle, Methodology, Rf values, advantages,
disadvantages and applications.
Paper chromatography– Introduction, methodology, development techniques, advantages,
disadvantages and applications.
Electrophoresis– Introduction, factors affecting electrophoretic mobility, Techniques of paper,
gel, capillary electrophoresis, applications.

Unit-IV

Gas chromatography – Introduction, theory, instrumentation, derivatization, temperature
programming, advantages, disadvantages and applications.
High performance liquid chromatography (HPLC)- Introduction, theory, instrumentation,
advantages and applications.

Unit-V

Ion exchange chromatography- Introduction, classification, ion exchange resins, properties,
mechanism of ion exchange process, factors affecting ion exchange, methodology and
applications.
Gel chromatography- Introduction, theory, instrumentation and applications.
Affinity chromatography- Introduction, theory, instrumentation and applications

BP702T. INDUSTRIAL PHARMACY II (Theory)

Unit-I

Pilot plant scale up techniques: General considerations- including significance of personnel
requirements, space requirements, raw materials, Pilot plant scale up considerations for solids,
liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to
platform technology.

Unit-II

Technology development and transfer: WHO guidelines for Technology Transfer (TT):
Terminology, Technology transfer protocol, Quality risk management, Transfer from RD to
production (Process, packaging and cleaning), Granularity of TT Process (API, excipients,
finished products, packaging materials) Documentation, Premises and equipment, qualification
and validation, quality control, analytical method transfer, Approved regulatory bodies and
agencies, Commercialization – practical aspects and problems (case studies), TT agencies in
India – APCTD, NRDC, TIFAC, BCIL, TBSE
/SIDBI; TT related documentation – confidentiality agreement, licensing, MoUs, legal issues.

Unit-III

Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory
authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs
Professionals.
Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug
Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of
Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug
Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in
Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of
Clinical Studies.

Unit-IV

Quality management systems: Quality management & Certifications: Concept of Quality,
Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications
(OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO
14000, NABL, GLP.

Unit-V

Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and
State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product
(COPP), Regulatory requirements and approval procedures for New Drugs

BP703T. PHARMACY PRACTICE (Theory)

Unit-I

Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification
based on clinical and non-clinical basis, Organization Structure of a Hospital, and Medical staffs
involved in the hospital and their functions.
Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff
requirements, and Responsibilities and functions of hospital pharmacists.
Adverse drug reaction
Classifications – Excessive pharmacological effects, secondary pharmacological effects,
idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden
withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and
pharmacokinetic drug interactions, Methods for detecting drug interactions, spontaneous case
reports and record linkage studies, and Adverse drug reaction reporting and management.
Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal
requirements for establishment and maintenance of a drug store, Dispensing of proprietary
products, maintenance of records of retail and wholesale drug store.

Unit-II

Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and
labeling. Dispensing of drugs to ambulatory patients and dispensing of controlled drugs.
Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and Drug
list, preparation and revision, and addition and deletion of drug from hospital formulary.
Therapeutic drug monitoring
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug
Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
Medication adherence
Causes of medication non-adherence, pharmacist role in the medication adherence and
monitoring of patient medication adherence.
Patient medication history interview
Need for the patient medication history interview, medication interview forms.
Community pharmacy management
Financial, materials, staff, and infrastructure requirements.

Unit-III

Pharmacy and therapeutic committee
Organization, functions, Policies of the pharmacy and therapeutic committee in including drugs
into formulary, inpatient and outpatient prescription, automatic stop order, and emergency drug
list preparation.
Drug information services
Drug and Poison information centre, Sources of drug information, Computerized services, and
storage and retrieval of information.
Patient counselling
Definition of patient counselling; steps involved in patient counselling, and Special cases that
require the pharmacist
Education and training program in the hospital
Role of pharmacist in the education and training program, Internal and external training
program, Services to the nursing homes/clinics, Code of ethics for community pharmacy, and
Role of pharmacist in the interdepartmental communication and community health education.
Prescribed medication order and communication skills
Prescribed medication order- interpretation and legal requirements, and Communication skillscommunication with prescribers and patients.

Unit-IV

Budget preparation and implementation: Budget preparation and implementation. Clinical
Pharmacy: Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions and
responsibilities of clinical pharmacist, Drug therapy monitoring- medication chart review,
clinical review, pharmacist intervention, Ward round participation, Medication history and
Pharmaceutical care. Dosing pattern and drug therapy based on Pharmacokinetic & disease
pattern.
Over the counter (OTC) sales: Introduction and sale of over the counter and rational use of
common over the counter medications.

Unit-V

Drug store management and inventory control
Organization of drug store, types of materials stocked and storage conditions, Purchase and
inventory control: principles, purchase procedure, purchase order, procurement and stocking,
Economic order quantity, Reorder quantity level, and Methods used for the analysis of the drug
expenditure.
Investigational use of drugs
Description, principles involved, classification, control, identification, role of hospital pharmacist,
advisory committee.
Interpretation of Clinical Laboratory Tests Blood chemistry, haematology and urine analysis.

BP704T. NOVEL DRUG DELIVERY SYSTEMS (NDDS) (Theory)

Unit-I

Controlled drug delivery systems: Introduction, terminology/definitions and rationale,
advantages, disadvantages, selection of drug candidates. Approaches to design-controlled release
formulations based on diffusion, dissolution and ion exchange principles. Physicochemical and
biological properties of drugs relevant to controlled release formulations.
Polymers: Introduction, classification, properties, advantages and application of polymers in
formulation of controlled release drug delivery systems.

Unit-II

Microencapsulation: Definition, advantages and disadvantages, microspheres
/microcapsules, microparticles, methods of microencapsulation, applications.
Mucosal Drug Delivery system: Introduction, Principles of bioadhesion/mucoadhesion,
concepts, advantages and disadvantages, transmucosal permeability and formulation
considerations of buccal delivery systems.
Implantable Drug Delivery Systems: Introduction, advantages and disadvantages, concept of
implants and osmotic pump.

Unit-III

Transdermal Drug Delivery Systems: Introduction, Permeation through skin, factors affecting
permeation, permeation enhancers, basic components of TDDS, formulation approaches.
Gastro-retentive drug delivery systems: Introduction, advantages, disadvantages, approaches
for GRDDS– Floating, high density systems, inflatable and gastro-adhesive systems and their
applications.
Naso-pulmonary drug delivery system: Introduction to Nasal and Pulmonary routes of drug
delivery, Formulation of Inhalers (dry powder and metered dose), nasal sprays, nebulizers.

Unit-IV

Targeted drug Delivery: Concepts and approaches advantages and disadvantages, introduction
to liposomes, niosomes, nanoparticles, monoclonal antibodies and their applications.

Unit-V

Ocular Drug Delivery Systems: Introduction, intra ocular barriers and methods to overcome–
Preliminary study, ocular formulations and ocuserts.
Intrauterine Drug Delivery Systems: Introduction, advantages and disadvantages,
development of intra uterine devices (IUDs) and applications.

Conclusion

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