Formulation development is the process of combining an active drug with other ingredients to create a stable, bioavailable, and effective final product. It involves pre-formulation studies, design and testing, manufacturing, and stability testing. The goal is to identify the most effective delivery method for the active drug. Key steps include analytical development, particle characterization, dissolution testing, and excipient screening. Drugs then progress through preclinical and clinical research phases to test safety and efficacy before seeking regulatory approval. Post-approval monitoring ensures the drug's safe use. Factors like a drug's properties, intended use, and stability studies guide its formulation.

1. Formulation
Development

2. Formulation Development
• Formulation development means
identifying the most widely accepted form
with the most bioavailability. A
pharmaceutical company must also
decide when, where, and how an API is
delivered once a drug is taken.The
formulation development process
involves several stages, including. Pre-
formulation studies, formulation design
and evaluation, manufacturing scale-up
and process development, analytical
development and characterization, and
stability and shelf-life
determinations.Pharmaceutical
formulation is a process of combining
different chemical substance with the
active drug to form the final Stable
medical product.

3. Objective of Drug development
• To produce a final medicinal product
to produce stable drug.It must be
suitable for the patient.The goal of
formulation development in the
pharmaceutical industry is to create
a drug product that is stable,
bioavailable (able to be absorbed by
the body), and effective for the
intended use.

4. Step in Formulation
Development
• Pre-formulation.Analytical Assay
Development and
Characterization.Particle Size
Analysis and
Characterization..Dissolution
Testing.Excipient Screening.Dosage
Form Development.

5. Pre-formulation
• Preformulation is the stage of development during
which the physicochemical properties of the drug
substance are characterised and established.
Knowledge of the relevant physiochemical and
biopharmaceutical properties determines the
appropriate formulation and delivery method for
Pre-Clinical and Phase 1 studies. Preformulation is
a group of studies that focus on the
physicochemical properties of a new drug
candidate that could affect the drug performance
and the development of a dosage form.

6. Analytical Assay Development
and Characterization
• Analytical procedures are developed to test specific
characteristics of the substances against the
predefined acceptance criteria for such characteristics.
Thus, analytical method development involves the
evaluation and selection of the most precise assay.
• Analytical development can be described as a related
series of tasks where test methods are developed and
qualified to support drug development phases.

7. Particle Size Analysis and
Characterization
• Particle size (PS) analysis is used to assess the particle
size and particle size distribution (PSD) along with some
other parameters such as zeta potential in a specimen.
The application of this technique is extended to aerosols,
emulsions, suspensions, and solid materials.
• Particle characterization is the process of identifying
various particles and grouping into categories by particle
size, shape, surface properties, mechanical properties,
charge properties, and microstructure. The nature of
particle counting is based upon either light scattering, light
obscuration, or direct imaging.

8. Dissolution Testing
• Dissolution is the process in which a substance forms a
solution. Dissolution testing measures the extent and rate of
solution formation from a dosage form, such as tablet,
capsule, ointment, etc. The dissolution of a drug is
important for its bioavailability and therapeutic
effectiveness.
• Types of dissolution Testing
• There are seven types of dissolution apparatus. We offer
United States Pharmacopeia (USP) Apparatus .
• Baskets
• Paddles
• Reciprocating cylinder
• Paddle over disk
• Rotating cylinder
• Reciprocating disk

9. Excipient
Screening PHARMACEUTICAL EXCIPIENTS ARE
SUBSTANCES OTHER THAN THE ACTIVE
PHARMACEUTICAL INGREDIENT (API)
THAT HAVE BEEN APPROPRIATELY
EVALUATED FOR SAFETY AND ARE
INTENTIONALLY INCLUDED IN A DRUG
DELIVERY SYSTEM.
THE PROCESS BEGINS WITH THE
IDENTIFICATION OF A DISEASE OR A
THERAPEUTIC AREA WITH AN UNMET NEED.
ONCE A “DRUGGABLE” TARGET IS FOUND,
THE PROCESS OF DRUG SCREENING
STARTS. IN DRUG SCREENING, MOLECULES
THAT CAN INTERACT WITH THE TARGET
AND/OR FACILITATE THE DESIRED
PHENOTYPIC RESPONSE ARE IDENTIFIED.

10. Type of formulation
• Enternal Formulation
• Parenteral Formulation
• Topical Formulation

11. Enternal Formulation
• 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.

12. Parenteral Formulation
• Available in liquid or lyophilized formUsed
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 refrigerator.

13. Topical formulation
• Topical formulations are made up in
a vehicle, or base, which may be
optimised for a particular site of the
body or type of skin condition. The
product may be designed to be
moisturising or to maximise the
penetration of an active ingredient,
often a medicine, into or through the
skin.

14. Drug Development phases
• Phase 1: discovery and
development Phase 2: preclinical
researchPhase 3: clinical
researchPhase 4 clinical trialsPhase
5: FDA Post-Market Safety
Monitoring:-

15. Phase 1: Discovery and
development
• 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.

16. Phase 2:Preclinical research
• ▸ 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.
• Research for a new drug begins in the laboratory.
Drugs undergo laboratory and animal testing to
answer basic questions about safety. Drugs are
tested on people to make sure they are safe and
effective.

17. Phase 3:Clinical research
• 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.

18. Submission for FDA approval:
New drug application (NDA)
• 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.

19. Phase 4: Clinical trials
• 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.

20. Phase 5: FDA Post-Market Safety
Monitoring
• 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.

21. Regulatory approval
• 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.

22. Factors Considered During
Pharmaceutical Formulations
• › 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.

23. Conclusion
• Implementation of a NPD process with
stages has helped businesses focus
their New Product investment on the
most potentially rewarding projects.It
has shortened the time between idea
and revenue by orchestrating the
complex set of activities required for
the commercial success of new
products.

24. Reference:-
• 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.co
m/drug-discovery-and-development-
process/amp/.3.https://www.investopedia.com/artic
les/investing/072913/8-stages-new-drug-
development.asp4.https://www.scribbr.com/categor
y/research-
paper/.5.https://www.slideshare.net/mobile/cognibr
ain/formulation- research-and-development-
service.