1. Pharmaceutical and
Formulation Considerations

2. What is Pharmaceutical
technology?
• Pharmaceutical Technology is the discipline of
pharmacy that deals with the process of turning a
new chemical entity (NCE) into a medication to be used
safely and effectively by patients.
• It is also called the science of dosage form design.
• It deals with the formulation of a pure drug substance
into a dosage form

3. Drug and medicine
• Medicine is actually the drug delivery system
• That is, they are means of introducing drugs to the body
in safe, efficacious, reproducible and convenient ways
• Medicines are rarely drugs alone, but requires excipients
or additives or pharmaceutical ingredients to be
formulated into dosage forms

4. Different Dosage Forms

5. Pharmaceutical ingredients or excipients
• The non-medicinal agents that are given as parts of a
formulation in combination with a drug substance to
produce a final dosage form and serve varied and
specialized pharmaceutical functions are known as
pharmaceutical ingredients or excipients.
• Examples:
For solutions- solvents, flavors, sweeteners, colorants,
preservatives, stabilizers etc.
For tablets- diluents or fillers, binders, lubricants,
disintegrating agents etc.

6. What are the purposes of formulating
different types of dosage forms?
• In order to provide the safe and appropriate dose of a
drug to the patient, drug substances are formulated in a
dosage forms
• Selective use of different excipients produces dosage
forms of various types
• Besides providing the safe and convenient delivery of
accurate dosage, there are different purposes for which
different dosage forms are designed.
These are :
1) To protect the drug substance from the destructive
influences of atmospheric oxygen or humidity (coated
tablets, sealed ampuls)

7. Sealed ampoules and coated
tablets

8. The purposes …
2) To protect the drug substance from the destructive
influences of gastric acid after oral administration
( enteric coated tablets)

9. The purposes …
3) To conceal the bitter, salty or offensive taste or odor of
a drug substance (capsules, coated tablets, flavored
syrups)
4) To provide liquid preparations of substances that are
either insoluble or unstable in the desired vehicle
( suspensions)

10. The purposes …
5) To provide clear liquid dosage forms of substances
( syrups, solution)
6) To provide rate-controlled drug action ( various
controlled release tablets, capsules and suspensions)
7) To
provide optimal drug action from topical administration
sites ( ointments, creams, transdermal patches and
ophthalmic ear & nasal preparations)

11. The purposes …
8) To provide for insertion of a drug into one of body’s
orifices ( rectal or vaginal suppositories)

12. The purposes …
9) To provide for placement of drugs directly in the
bloodstream or body tissues (injections)
10) To provide for optimal drug action through inhalation
therapy ( inhalants and inhalation aerosols)

13. Major considerations in dosage form design
• Three major things should be considered before
designing a dosage form :
-The physicochemical considerations
- The biochemical considerations
- Determination of the desired product type and
establishment of a framework for product development

14. Major considerations ….
• Then, various initial formulations of the product are
developed and examined for desired features (e.g., drug
release profile, bioavailability, clinical effectiveness etc.)
• The formulation that best meets the goals for the product
is selected as “master formula”.

15. Major considerations ….
• Then a pilot batch and subsequently large scale
production is carried on
• Each of the subsequently prepared batch of the product
must meet the specifications established in the master
formula
• Most commonly a manufacturer prepares a drug
substance in several dosage forms and strengths for the
efficacious and convenient treatment of disease

16. Major considerations….
• Some therapeutic matters are also considered before
formulating different kinds of dosage forms like- nature of illness ( whether emergency or not)
- manner of treatment ( whether local or systemic action)
- the age and anticipated condition of the patient ( for
infants and children liquid preparation is preferred, for
young patient with cough & vomiting injections or
suppositories are preferred)

17. Major considerations….
- in case of swallowing problem, chewable tablet or
capsules may be prepared
-
to reduce the frequency of administration, sustained
release or extended released form is preferred
- Thus the therapeutic considerations, in turn helps to
decide the suitable dosage form, the appropriate route of
administration, suitable duration and dose frequency if
the drug in question