PHARMACEUTICAL FORMULATION :-

Pharmaceutical formulation is a process of

combining different chemical substance with the
active drug to form the final Stable medical
product.
 To produce a final medicinal product to
produce a stable drug.
 And it must be suitable for the patient
 • Physical, chemical, and mechanical
properties of drug substance
 • Polymorphism, solubility, pH, and particle
size of drug
 • Inactive ingredients or excipients to be
added
 • Effectiveness of the drug in phase I clinical
trials
 • Results of drug stability studies
 . These factors are known through
preformulation studies
 • Enteral formulations

 • Parenteral formulations

 • Topical formulations
 o Available as capsules or tablets and Used
for oral administration of the drug o Can
provide rapid effect or sustained release from
the digestive tract
 Available in liquid or lyophilized form
 Used for intravenous, intra-articular,
intramuscular, and subcutaneous
administration.
 Liquid form is preserved in ampoules, IV
bags, vials, and prefilled syringes in
refrigerators
 Lyophilized form is kept in dual chamber
syringes, cartridges, and vials in refrigerators
 Available as creams, ointments, powders or
inhaling formulas .

 Used for skin application or nasal

administration
 Phase 1: discovery and development
 Phase 2: preclinical research
 Phase 3: clinical research
 Phase 4 clinical trials
 Phase 5: FDA Post-Market Safety Monitoring:-
 Pharma companies spend millions of dollars
on research and development that includes
scientific study and development of drugs for
new innovation. Drug discovery is how new
medications are discovered
 Preclinical research is a basic preliminary
phase that involves testing the drug on
animals and basic testing for safety flags.
Once a lead compound is found, drug
development begins with preclinical research
to determine the efficacy and safety of the
drug
 It generates data for discovering and verifying
the Clinical, pharmacological (including
pharmacodynamics and pharmacokinetic) and
adverse effects with the objective of
determining safety and efficacy of the new
drug
 When phase III clinical trials (or sometimes
phase II trials) show a new drug is more
effective or safer than the current treatment,
a new drug application (NDA) is submitted to
the Food and Drug Administration (FDA) for
approval.
 A phase 4 clinical trial begins after a drug has
been approved for use in the general
population following phase 1, 2 and 3 trials
to rigorously test its efficacy and safety.
 There are several aspects of post-approval
safety monitoring for a marketed drug.
 The FDA monitors all types of drug
advertising for accuracy. It also monitors
complaints and problems associated with a
drug.
 It monitor the safety of drug post marketing.
 IND Application:-IND applications are
submitted to the FDA before starting clinical
trials.
 The FDA is involved in the patent protections
and generic drug transitions of all drugs.
Following drug approval and manufacturing,
the FDA requires drug companies to monitor
the safety of its drug using the FDA adverse
event reporting system (fears) database
 A definitive project plan in terms of scope,
timelines and goals will help the contract
service provider offer realistic cost estimates
and detailed proposals.
 The greater the up-front communication

1.https://www.google.com/amp/s/www.news-
medical.net/amp/health/what-is-a-phase-4-clinical-trial.aspx.
2.https://www.google.com/amp/s/www.nebiolab.com/drug-
discovery-and-development-process/amp/.
3.https://www.investopedia.com/articles/investing/072913/8-
stages-new-drug-development.asp
4.https://www.scribbr.com/category/research-paper/
5.https://www.slideshare.net/mobile/cognibrain1/formulation-
research-and-development-services