Research Methodology

Introduction to Laboratory Research in Pharmacy and Pharmaceutical

Sciences
Learning Outcome
• Identify the scopes of Laboratory research in Pharmacy and
Pharmaceutical Sciences
• Describe the significance of Laboratory research
• Compare the applications of research involving various aspects
research pharmaceutical sciences
• Identify the requirements of laboratory research
• Identify the outcome of research in each speciality of pharmacy and
pharmaceutical sciences
• Plan a research involving interdisciplinary research integrating various
scopes of research in pharmacy and pharmaceutical sciences
What is laboratory research?
• A laboratory is a facility that provides controlled conditions in which scientific or
technological research, experiments, and measurement may be performed.
• It involves the use of laboratory equipment, available and novel chemicals, experimental
animals, docking software to develop basic information about the possibility of
 discovering the novel therapeutic agents,

 toxicity analysis,

 modification of therapeutic activity,

 enhancement of formulation,

 development of formulations and

 determination of efficacy of chemicals/drugs and formulations against various diseases and

disorders
Major areas of research in Pharmacy and Pharmaceutical Sciences

• Pharmacognosy/Phytochemistry (herbal research)

• Synthetic Chemistry
• Pharmacology and Toxicology
• Microbiology & Biotechnology
• Pharmaceutical Technology
• Pharmaceutical Analysis (qualitative and quantitative)
 Scopes and outcome of Herbal Research
• Compilation of knowledge on traditional use of herbs in the
treatment of various diseases
• Identifying the species of interest for scientific evaluation of
traditional claims
• Common methods
• Collection of material
• Identification and Authentication of the plants/herbs
• Raw material characterization
• Phytochemical investigation
• Pharmacological Evaluation by using experimental techniques (in-vivo and in-silico
methods)
Risk factors in Herbal/phytochemical Research
• Compilation of appropriate and accurate knowledge
• Identification of species
• Phytochemical analysis (complexity of constituents) –Seasonal
variations in the phytoconstituents
• Analytical methods
• Bias/ difficulties in drawing conclusions
 Common Techniques
• Planning a research study
• Identification the species of interest
• Application of methods and techniques for extraction of
phytoconstituents
• Isolation/Identification and confirmation of phytoconstituents
• Use of drying techniques
• Use of solvent/solvents (single, multiple and combination of solvents)
• Application of analytics techniques (Simples chemical reactions
Chromatography, and spectroscopy)
• Pharmacological evaluation
 Outcome of herbal/phytochemical research
• Justifying or rejecting the traditional claims
• Acquiring knowledge on diversity of phytoconstituents
• Basis for drug discovery
 Pharmaceutical/Medicinal Chemistry
• Synthesis of novel agents/chemicals for testing their potential as
therapeutic agents
• Modification of available chemicals/drugs for enhancement of activity
• Modification of chemicals for non-conventional uses
 Significance of Pharmaceutical/Medicinal
Chemistry Research
• Backbone of drug discovery

• Discovery of novel therapeutic agents

• Improvement of therapeutic efficacy of drug molecules through
appropriate modifications in chemical structures
 Methods and Techniques
• Application of various mechanisms for synthesis of drugs
• Baeyer-Villiger oxidation
• Beckmann rearrangement Birch reduction
• Claisen condensation
• Claisen rearrangement
• Claisen-Schmidt reaction
• Dieckmann condensation
• Diels-Alder reaction
• Favorski rearrangement
• Fisher esterification
• Friedel-Crafts acylation
• Friedel-Crafts alkylation
• Grignard reaction and ETC
 Methods and Techniques
• Application of analytical methods including
• Chemical assays
• Spectroscopy (IR, NMR, Mass)
• Chromatography (HPLC, HPTLC, Gas)
• Pharmacological evaluations (Experimental animals, docking software)
 Risk factors in Pharmaceutical/Medicinal
Chemistry Research
• Stability/reactivity of chemicals (safety of handling)
• Choice of analytical methods
• Toxicity
 Outcome of Pharmaceutical/Medicinal
Chemistry Research
• Discovery of novel therapeutic agents
• Improvement of therapy
• Modification of drugs/chemicals for non-conventional uses
• Main source of all drugs/drug discoveries
 Pharmacological Research
• Any chemical to be called as drug must be subjected to
pharmacological evaluation to establish its safety and efficacy. Hence,
the use of chemicals as therapeutic agents is mainly dependent on
the outcome of their pharmacological evaluation
• Scope
• Pharmacological Evaluation
• Toxicology
• Therapeutic efficacy
 Essential Requirements
• Well stablished animal house (and availability of variety of
experimental animals and the distinct species)
• Laboratory instruments/equipment for pharmacological testing
• Software (in-silico) analysis
• Ethical approvals
 Scopes of Pharmacological Research
• Decisive studies to recommend the use of chemicals as therapeutic
agents (to proceed for clinical research)
• Determination of safety (toxicity) and efficacy (therapeutic potential)
of the chemicals/drugs
• Establishing pharmacokinetic profiles of the drugs
• Interaction studies (drug-drug, drug food etc)
• Recommended dosing for conventional and non-conventional uses of
drugs
 Outcome of Pharmacological Research
• Recommendations on appropriateness of use of a chemical/drug
obtained from any source (natural, synthetic, semi-synthetic)
• Selection of appropriate route of drug administration to achieve
maximum therapeutic effects
• Foundation for clinical studies of novel chemicals or use of existing
drugs for non-conventional applications
Research in Microbiology and Biotechnology
• Microbes, a well known source of drugs particularly antibiotics, and
enzymes
• Use of microbes to evaluate the efficacy of chemicals/drugs obtained
from any source
• Application of Biotechnological principles to enhance quality and
quantity of production
• Use rDNA technology to modify the microbial/herbal genetics
• Use of genetically modified species to improve the quality of products
 Risk factors
• Acquired infections/contamination
• Handling of specimens
• Sensitivity/allergic reactions
• Ethical/Moral/religious barriers
Techniques and applications
• Sterilization, sterility testing
• Antibiotic assays
• Quality enhancement of products
• Genetic modifications of plants and microbes (biotechnology)
 Outcome of Microbiology/Biotechnology
Research
• Discovery of microbes/microbial products
• Selection of appropriate drugs to treat infections (antibiotic sensitivity
testing)
• Enhancement of quality and quantity of products (biotechnology
research)
• Source of drug discovery and application
Pharmaceutical Technology – Research
• Ensures the efficacy therapy through appropriate use of drugs in the
appropriate dosage forms using the most suitable route of drug
administration
• All the drugs must be formulated in one or the other dosage forms
• Pharmaceutical research remains incomplete without the application
of formulation technology
 Scopes of Pharmaceutical Technology Research
• Discovery of adjuvants
• Preformulation studies
• Development of conventional dosage forms (appropriate for use in a
variety of patients)
• Development of novel drug delivery systems to achieve greater
therapeutic outcome
• Determines of physical stability and therapeutic efficacy of the drugs
and the dosage forms
• Stability studies to establish expiry date
 Risk factors
• Availability of chemicals
• Availability of pure drugs
• Apparatus and equipment
• Optimization of formulation
• Stability analysis
Outcome of the P’technology research
• Establishing fundamental data for new adjuvants/conventional
adjuvants from novel sources
• Improvement of efficacy through improvement in drug delivery
technology
• Enhancement of quality and stability of the formulations
• Novel dosage forms, appropriate for various routes of drug
administration
• Fulfilling the needs of variety of consumers (paediatrics, geriatric and
patients with special needs)
Analytical Research
• Determining the accuracy of dosage, stability of dosage form,
appropriateness of content
• Essential for all the drug products and chemicals obtained from any
sources
• Find out the drug/drug interaction (chemical) and drug-excipient
interaction
• Stability of dosage form
• Expiry period
• Suitability of consuming the contents of the product
Risk factors
• Appropriateness of methods and techniques
• Availability of chemicals and equipment
• Analysis and interpretation of data
• Skills in decision making
Outcome of Analytical research
• Conclusions on stability and efficacy of the products
• Identifying contraband products
• Identifying the adulterants in the products
• Quality control and quality assurance
• Most important for commercialised products for each batch for
approval by analytical chemist before marketing (routine procedures
not essentially research)