Medication Absorption Breakthrough by Slidesgo.pptx

1. Role of Formulation
Development and Processing
.
SUBMITTED BY;
SIMRAN KARMAKAR ( 97/MIP/SPS/23)
M PHARMACY ( INDUSTRIAL PHARMACY)
SUBMITTED TO:
Dr. GEETA

2. Table of contents
02 05
What Is Drug
Formulation?
Factors
Drug development
process
Discussion
Conclusion
03
06
01 04

3. Introduction
01

4. What Is Drug Formulation?
● Drug formulation is the process of
determining the best way to deliver this
active ingredient.
● Also known as pharmaceutical
formulation, drug formulation involves
combining different inactive substances
with the active pharmaceutical
ingredient (API) to produce an end-
product for patients.

5. .
Drug formulation is one of the most critical
aspects of the pharmaceutical development
process. If a drug cannot be delivered in a
stable form that is acceptable to the patient,
it is unlikely to find a sizable market, and it
may not even go beyond phase I clinical
trials.
Formulation Development: Why It’s So
Important

6. The Pharmaceutical Formulation
Development Process
.
Drug preformulation studies are the first step in
formulation development.
During this phase, we identify the chemical,
physical, and mechanical properties of a drug to
determine the inactive ingredients, or excipients, that

8.  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
Factors Considered During Pharmaceutical
Formulation

9. Drug Formulation Types
Tablet formulation-
These typically contain five to 10 percent of
the active substance, 80 percent inactive
ingredients, and 10 percent compounds that
promote dissolution in the digestive tract.

11. Capsule Formulation
Capsules involve encasing the active substance in a “shell” made
with a gelling agent that dissolves in the stomach.
Oral Liquid Formulation
Liquid formulations are faster and less expensive to develop, and
they often have better bioavailability than other oral formulations.
Sustained Release Formulation
Sustained release formulations can be tablets or capsules. They are
meant to release a drug into the system more slowly.

13. 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

14. 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

15. Why Is Drug Formulation Development Important?
Aside from the initial discovery of a new drug, drug formulation is
perhaps the most important part of the development process. It can
make or break a drug; if a molecule cannot be made stable, it
cannot go to market.

16. 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

17. 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.

18. 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.

19. 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.

20. 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

21. 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

22. Factors in Choosing a Formulation
1) Stability
A drug that is not physically or chemically
stable is difficult to manufacture, ship, and
store. Overcoming these challenges often
comes at a high cost. It’s more effective to put
in the work to find a stable formulation in
various conditions and environments by
conducting stability studies.

23. A pharmaceutical company must also decide when,
where, and how an API is delivered once a drug is taken.
Most drugs begin to be broken down and absorbed after
ingestion; parenteral drugs bypass the digestive system
and are absorbed more quickly. Then, targeted delivery
drugs deliver drugs only to the target site without
impacting other tissues. Drugs with enteric coatings are
broken down and absorbed in different parts of the
intestines.
Bioavailability

24. Outsourcing Drug Formulation Development to a
CDMO
It’s common for pharmaceutical companies to outsource
formulation development because they don’t have the
resources to do the job themselves. Even large
pharmaceutical companies may not have the time needed to
build the right team for formulating early-stage
compounds. Biotech start-ups, academia, and other small
pharmaceutical companies are often unable to conduct drug
formulation research in-house or are unable to do so
efficiently.

25. The advantages of using a CDMO for formulation include:
Accelerated Formulation Development
CDMOs are used to working with tight timelines and have the
resources to hit the ground running, rather than spending
valuable time assembling a team, establishing supply chains,
etc.

26. Expertise
CDMOs that support discovery and preclinical research must have
expertise in pre-formulation, formulation, and biopharmaceutics. They
should also have proprietary methodologies to develop formulations from
small quantities of an API for different routes of administration.
.

27. Technology, Equipment, and Facilities
When choosing a CDMO, it’s critical to select a partner that can
utilize multiple technologies at the same time to address compound
challenges. Specialization in certain drug types or overcoming
common challenges is desirable, but proficiency in (and reliance on)
a single technology is not.
The advantage of nanotechnology is that it’s versatile enough to use
with a wide variety of drug delivery platforms, including oral solids,
liquids, gels, topicals, long-acting injectables, and implants.

28.  https://landing.ascendiapharma.com/drug-
formulation-development-process
 Zhou SF, Zhong WZ. Drug Design and Discovery: Principles
and Applications. Molecules. 2017 Feb 13;22(2) [PMC free
article] [PubMed]
REFERENCE