What is Pharmaceutics?
Introduction
Definition
Pharmaceutics is the discipline of pharmacy which deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
Pharmaceutics is the science and technology of providing medicine / Active Pharmaceutical ingredients into convenient dosage form to a patient.
Pharmaceutical dosage which contains Drug/Drugs and suitable excipients used for increase palatability,acceptability amd make good compliance.
Branches of Pharmaceutics
Pharmaceutics is a wider branch in pharmacy field.
1.Physical Pharmacy
2.Pharmaceutical Engineering
3.Pharmaceutical Dosage forms and Pharmaceutical Formulation / Manufacturing
4.Industrial Pharmacy
6.Modern Pharmaceutics
7.Computer Aided Drug Development (CADD)
8.Dispensing Pharmacy
9.Hospital Pharmacy and Clinical Pharmacy
10.Pharmaceutical Jurisprudence
11.Pharmaceutical Biotechnology ( e.g formulation vaccines and biological products for therpeutic use )
12.Biopharmaceutics
13.Nutraceutics
14.Cosmetics
15. Regulatory Affairs
Scope and Objectives of Pharmaceutics
1.Physical Pharmaceutics
Scope
Physical Pharmaceutics deals with the various physical and physicochemical properties, and principles involved in dosage forms/formulations. Theory and practical components of the subject help the student to get a better insight into various areas of formulation research and development, and stability studies of pharmaceutical dosage forms.
Objective
1.Understand the basics of different dosage forms, pharmaceutical incompatibilities and pharmaceutical calculations
2.Understand the professional way of handling the prescription
3. Preparation of various conventional dosage forms
4.Understand various physicochemical properties of drug molecules in the designing the dosage forms
5. Know the principles of chemical kinetics & to use them for stability testing and determination of expiry date of formulations
6. Demonstrate use of physicochemical properties in the formulation development and evaluation of dosage forms
2.Pharmaceutical Engineering
Scope:
Pharmaceutical Engineering course / subject is designed to impart a fundamental knowledge on the art and science of various unit operations used in pharmaceutical industry.
Objectives:
Upon completion of the course student shall be able understand:
1. To know various unit operations employed in Pharmaceutical industries.
2. To understand the material handling techniques.
3. To perform various processes involved in pharmaceutical manufacturing process / processes.
4. To carry out various test to prevent the environmental pollution.
5. To appreciate and comprehend significance of plant layout design for optimum use of resources.
6. To appreciate the various preventive methods used for control the corrosion in Pharmaceutical industries.
3.Industrial Pharmacy
Scope:
Industrial Pharmacy course that enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.
This course is designed to impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market
Objectives:
Upon completion of the industrial pharmacy course the student shall be able to
1. Know the various pharmaceutical dosage forms & their manufacturing techniques.
2. Know various considerations used in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and to evaluate them for their quality
4. Know the process of pilot plant and scale up of pharmaceutical dosage forms.
5. Understand the process of technology transfer from lab scale to commercial batch
6. Know different Laws and Acts that regulate pharmaceutical industry
7. Understand the approval process and regulatory requirements for drug products.
4.Drug Delivery System ( Novel Drug Delivery System )
Scope
This course is designed to impart knowledge on the area of advances in new / novel drug delivery systems.
Objectives
Upon completion of the course, student shall be able to understand the various consideration/approaches for development of novel drug delivery systems.
The criteria for selection of drugs and polymers for the development of drug delivery system.
To know the formulation and evaluation of Novel drug delivery systems.
5.Modern Pharmaceutics
Scope
Modern Pharmaceutics Course designed to imparts advanced knowledge and skills required to learn various aspects and concepts at pharmaceutical industries.
Objectives
Upon completion of the Modern Pharmaceutics course, student shall be able to understand
1.The elements of preformulation studies.
2. The Active Pharmaceutical Ingredients (API) and Generic drug Product development
3. Industrial Management and GMP Considerations.
4. Optimization Techniques used in pharmaceutical formulation & Pilot Plant Scale Up Techniques.
5. Stability Testing, sterilization process and packaging of dosage forms.
6.Molecular Pharmaceutics
Scope
Molecular Pharmaceutics subject / course is designed to impart knowledge on the area of advances in novel drug delivery systems.
Objectives
Upon completion of course , the student shall be able to understand
1. The various approaches for development of novel drug delivery systems.
2. The criteria for selection of drugs and polymers for development of NTDS.
3. To the formulation and evaluation of novel drug delivery systems.
7.Biopharmaceutics and pharmacokinetics
Scope
This course is designed to impart knowledge and skills necessary for dose calculations, dose adjustments and to apply biopharmaceutics theories in practical problem solving. Basic theoretical discussions of the principles of biopharmaceutics and pharmacokinetics are provides help to the student's for clarify the concepts.
Objectives
Upon completion of the course it is expected that students will be able understand to:
1.The basic concepts in biopharmaceutics and pharmacokinetics.
2. The use raw data and derive the pharmacokinetic models and parameters the best describe the process of drug absorption, distribution, metabolism and elimination.
3. The critical evaluation of biopharmaceutic studies involving in drug product equivalency.
4.The design and evaluation of dosage regimens of the drugs using pharmacokinetic and biopharmaceutic parameters.
5. The potential clinical pharmacokinetic problems and application of basics of pharmacokinetics.
8.Computer Aided Drug Development (CADD)
Scope
In this course is designed to impart knowledge and skills necessary for computer Applications in pharmaceutical research & development who want to understand the application of computers across the entire drug research and development process. Basic theoretical discussions of the principles of more integrated and coherent use of computerized information (informatics) in the drug development process are provides help to the students to clarify the concepts.
Objectives
Upon completion of this course it is expected which students shall be able to understand,
1. History of Computers in Pharmaceutical Research and Development
2. Computational Modeling of Drug Disposition
3. Computers in Preclinical Development
4. Optimization Techniques in Pharmaceutical Formulation
5. Computers in Market Analysis
6. Computers in Clinical Development
7. Artificial Intelligence (AI) and Robotics
8. Computational fluid dynamics(CFD)
9.Pharmaceutical Jurisprudence
Scope:
This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in worldwide.
Objectives:
Upon completion of the course, the student shall be understand to:
1. The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws.
3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals.
4. The code of ethics during the pharmaceutical practice.
10.Pharmaceutical Formulation Development
Scope
This course is designed to impart knowledge and skills necessary to train the students on par with the routine of Industrial activities in R&D and F&D.
Objectives
On completion of the course, it is expected which students will be able to understand-
1. The scheduled activities in a Pharmaceutical firm.
2. The pre formulation studies of pilot batches of pharmaceutical industry.
3. The significance of dissolution and product stability.
11.Pharmaceutical Production Technology
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in Production.
Objectives
On completion of this course it is expected that students will be able to understand,
1. Handle the scheduled activities in a Pharmaceutical firm.
2.Manage the production of large batches of pharmaceutical formulations.
12.Pharmaceutical Biotechnology
Scope:
1.Biotechnology has a long promise to revolutionize the biological sciences and technology.
2. Scientific application of biotechnology in the field of genetic engineering, medicine and fermentation technology makes the subject interesting.
3. Biotechnology is leading to new biological revolutions in diagnosis, prevention and cure of diseases, new and cheaper pharmaceutical drugs.
4. Biotechnology has already produced transgenic crops and animals and the future promises lot more.
5. It is basically a research-based subject.
Objectives:
Upon completion of the subject student will be able to:
1. Understanding the importance of Immobilized enzymes in Pharmaceutical Industries.
2. Genetic engineering applications in relation to production of pharmaceuticals.
3. Importance of Monoclonal antibodies (MAB) in Industries.
4. Appreciate the use of micro-organisms in fermentation technology.
13. Cosmetics and Cosmeceuticals
Scope
This course is designed to impart knowledge and skills necessary for the fundamental need for cosmetic and cosmeceutical products in briefly.
Objectives
Upon completion of the course, which students shall be able to understand
1. Key ingredients used in cosmetics and cosmeceuticals.
2. Key building blocks for various formulations.
3. Current technologies in the market
4. Various key ingredients and basic science to develop cosmetics and cosmeceuticals
5. Scientific knowledge to develop cosmetics and cosmeceuticals with desired Safety, stability, and efficacy.
14.Scale Up and Technology Transfer
Scope :
This course is designed to impart knowledge and skills necessary to train the students to be on scale up (small to large scale ), technology transfer process and industrial safety issues.
Objectives:
On completion of this course it is expected which students shall be able to understand:
1. Manage the scale up process in pharmaceutical industry.
2. Assist in technology transfer.
3. To establish safety guidelines, which prevent industrial hazards.
15.Intellectual Property Rights
Scope:
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in drug regulatory affairs.
Objectives:
On completion of this course it is expected that students will be able to understand,
1. Assist in Regulatory Audit process.
2. Establish regulatory guidelines for drug and drug products.
3.The Regulatory requirements for contract research organization (CRO).
16.Pharmaceutical Regulatory Science and Regulatory Affairs
Scope:
This course is designed to impart the fundamental knowledge on the regulatory requirements for approval of new drugs, and drug products in regulated markets of India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students to learn in detail on the regulatory requirements, documentation requirements, and registration procedures for marketing the drug products.
Course designed to impart advanced knowledge and skills required to learn the concept of generic drug and their development, various regulatory filings in different countries, different phases of clinical trials and submitting regulatory documents : filing process of IND, NDA and ANDA
1. To know the approval process of
2. To know the chemistry, manufacturing controls and their regulatory importance
3. To learn the documentation requirements for
4. To learn the importance and objectives
Objectives:
Upon completion of the subject student shall be able to;
1. Know about the process of drug discovery and development.
2. Know the regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals.
3. Know the regulatory approval process and their registration in International markets.
4. The Concepts of innovator and generic drugs, drug development process.
5. The Regulatory guidance’s and guidelines for filing and approval process.
6. Preparation of Dossiers and their submission to regulatory agencies in different countries.
7. Post approval regulatory requirements for actives and drug products.
8. Submission of global documents in CTD/ eCTD formats.
9. Clinical trials requirements for approvals for conducting clinical trials.
10. Pharmacovigilence and process of monitoring in clinical trials.
Pharmaceutics is a branch of study for making convenient dosage form to patient. Each and every part and chapter of pharmaceutics is very very important for practically working in pharmaceutical productions.
Pharmaceutics studied person not only involve to develop allopathy drugs into a dosage form.He is plays major role in develop/ formulation of herbal drugs and other source in Siddha, auyrveda, homeopathy and other alternative system.
Pharmaceutics are is sea. It swim in/ into /with other pharmacy branches pharmacology, pharmacognosy, pharmaceutical chemistry ( medicinal chemistry ) and pharmaceutical analysis.
How other branches of pharmacy used in Pharmaceutics
We tell how other pharma branches plays a role in pharmaceutics in pharmaceutical formulation :
Pharmacology
Pharmacology help to know pharmacological activity, pharmacokinetics, pharmacodynamics, dose,side effects, interactions and etc. Pharmacokinetic profile of drug and dose of drug useful in making dosage for for children and adults. ADME parameters useful for adjusting dose or diseased condition patients ( e.g, kidney failure or liver failure ), Lethal dose , half life, Maximum and minimum safety concentration of drugs used for frequency of administration for maintaing dose in blood. Interactions of drugs with drug and food useful in make combination product ( e.g, do not combine stimulant and depressants drugs shows no action like opposing each other ) and use of excipients.
Pharmacognosy
provides details about physiology and chemical constituents , method of extraction. After we make a formulation using herbal and other source of drugs in Siddha, ayurveda, homeopathy and other alternative systems.
Pharmaceutical chemistry
Pharmaceutical chemistry says about Structural activity relationship and optically active components ( they are have two forms which pharmacologically active and other is inactive or less ) after take consideration for formulation. Based on chemical structure of Drugs and additives gives idea about chemical interaction depend upon functional group and chemical nature.
Pharmaceutical Analysis
Pharmaceutical analysis plays a major role in drug anlaysis, additives and excipient individual analysis and anaylsis of pharmaceutical formulation . Pharmaceutical analysis using highly sensitive, accurate, recent technological instruments. It is used for compatability studies and analysing of raw materials of API and excipients, intermediate product, semi- finished product, finished product in real time batch. Always used for anlysing stability checking.
products.
" Pharmaceutics is a all rounder in pharmacy and in Pharmacy branchs over all "
Dosage Forms
Dosage form defined as the drug is combined with non -drugs ( excipients and additives ) and made to safety and effective convenient form and for intended to patients for prevent, treatment, diagnosis and mitigation of disease.
Dosage classification based on physical state ( solid, semi-solid, liquid and gas ), route of administration, and etc.
Drug Delivery System
Drug delivery to local, systemic effect and targeting based
The drug delivery system classified into two to three types
1.Conventional Drug Delivery System
2.Novel Drug Delivery system ( Controlled drug delivery system )
i. Sustained / Extended / Modified / Controlled release drug delivery system
ii. Gastro retentive drug delivery system
iii. Bioadhesive drug delivery system
iv. Transdermal drug delivery system
v.Ocular drug delivery system
vi.Nasopulmonary drug delivery system
vii. Proteins and peptides drug delivery system
viii. Vaccine drug delivery system
3.Targeted drug delivery system
Drugs targeted into various parts of body like Brain, Lungs, Liver, Pancreas , Colon, Rectum and drugs targeted to nucleic acids, genes, tissues and cells like tumour ( cancer tumour like brain tumour) etc. For targetting of drugs usings carriers ( e.g drug congucate with polymer and etc) and etc.
Targeted drug delivery system release in targeted site so it increase therapeutic effect and minimize the drug wastage, drug is release in targeted site , so no drug released in unwanted site or all over the body like systemic circulation.
E.g . Cancer chemotheraphy drugs cause hair fall and has cyto-toxicity.Hair fall mainly dueto cancer drug delivered to all over the body when take as a conventional drug delivery. Hair fall happen not only head , it happends in all over body dueto cancer drugs affect normal cells and scalp.It make to targeted delivery side effects like hair fall and cyto- toxicity is minimized.
i. Nanoparticles
ii. Liposomes,Niosomes,Aquasomes, Phytosomes ,Electrosomes, virosomes, cubosomes, ufasomes, and tranferosomes.
iii.Microspheres
When developing a formulation using various pharmaceutical additive like binder, disintegrants, film former, diluent / filler, plsticizer, preservatives, stabilizers, colourants sweetners, pH adjuster, tonicity adjuster, suspending agents, emulsifying agents, surfactants, emollient, gelling agent, viscosity builder etc.
Pharmaceutical products dispensed in a high quality, safty, packaging with informative label. For pharmaceutical packaging using materials are glass, plastic, metals and rubber.
Expiry date of product fixed by determining it shelf life of drug and excipients.
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