This document provides an introduction to pharmaceutics, which is concerned with the preparation and use of medicinal drugs. It discusses key topics including: - The sources of drugs, pharmacology analysis, and active ingredients - The design and manufacture of dosage forms, which combine active ingredients with excipients to facilitate drug delivery - Quality assurance processes to ensure safe and effective drug production in a consistent manner - The six main areas of pharmaceutics including physical chemistry principles, biopharmaceutics, dosage form design, manufacturing processes, sterilization, and product testing - Factors considered in dosage form design like drug properties, administration route requirements, and therapeutic indications

1. INTRODUCTION TO
PHARMACEUTICS
BY
MR. ALFRED CHOMBA CHANDA

2. Introduction
• The branch of pharmacology concerned with the preparation & use of
medicinal drugs.
• Pharmaceutics: Is concerned with the scientific and technological
aspects of the design and manufacture of dosage forms.
• Dosage forms: The means by which drug molecules are delivered to
sites of action within the body.

3. Introduction
• Drug sources: herbs, animals, synthetic
• Phytochemical analysis
• Pharmacological analysis
• Active ingredient/active principle ingredient (API)
• API: side effects, physical characteristics (e.g taste, colour), chemical
characteristics (e.g boiling point, melting point, reactivity)

4. Introduction
• Design & manufacture of dosage forms design
• Dosage form = API + excipients e.g tablets, capsules, syrups
• API: add excipients/additive to facilitate dosing, improve product
quality & to delivery to site of action (dosage form)

5. Introduction
• Manufacture technology: safe and effective response each for each
batch/lot
• Packaging: maintain stability, therapeutic performance of the product
& ensure patient convenience
• Quality assurance (QA): Way of preventing mistakes and defects in
manufactured products and avoiding problems when delivering
products or services to customers

6. Introduction
It encompasses 6 areas:
1. an understanding of the basic physical chemistry necessary for the effective
design of dosage forms (physical pharmaceutics)
2. an understanding of relevant body systems and how drugs arrive there
following administration (biopharmaceutics)
3. the design and formulation of medicines (dosage form design)
4. the manufacture of these medicines on a small (compounding), intermediate
(pilot-scale) and large (pharmaceutical technology, manufacturing) scale
5. the avoidance and elimination of microorganisms in medicines
(pharmaceutical microbiology, sterilization)
6. product performance testing (dissolution testing, drug release, stability
testing).

7. Principles of dosage form design
• Drugs are rarely administered as pure chemical substances alone and are almost
always given as formulated preparations or medicines.
• Pharmaceutical formulation additives perform the following functions
i. solubilize, suspend
ii. thicken
iii. preserve, emulsify,
iv. modify dissolution
v. improve the compatibility
vi. Improve the attractiveness
vii. Improve palatability
viii. Make the API more stable

8. Principles of dosage form design
• To optimize the bioavailability of drug substances, it is often necessary to
carefully select the most appropriate chemical form of the drug.
• such selection should address
1. solubility requirements
2. drug particle size
3. physical form
4. and appropriate additives
• Selecting the most appropriate route of administration and dosage
form(s).
• Additionally, suitable manufacturing processes, labelling and packaging are
required.

9. Principles of dosage form design
• There are numerous dosage forms into which a drug substance can be
incorporated for the convenient and efficacious treatment of a
disease.
• Dosage forms can be designed for administration by various delivery
routes to maximize therapeutic response.

10. Principles of dosage form design
• it is necessary to relate the drug substance to the clinical indication
being treated before the correct combination of drug and dosage
form can be made
• since each disease or illness often requires a specific type of drug
therapy.
• factors governing choice of administration route and the specific
requirements of that route which affect drug absorption need to be
taken into account when designing dosage forms.

11. Principles of dosage form design
• Many drugs are formulated into several dosage forms of varying
strengths, each having selected pharmaceutical characteristics which
are suitable for a specific application.
• E.g One such drug is prednisolone
1. Tablet
2. injections
3. eye drops and enema.

12. Principles of dosage form design
• The analgesic paracetamol is also available in a range of dosage forms
and strengths to meet the specific needs of the user, including
• tablets, dispersible tablets, paediatric soluble tablets, paediatric oral
solution, sugar-free oral solution, oral suspension, double-strength
oral suspension and suppositories.

13. Principles of dosage form design
• It is apparent that before a drug substance can be successfully formulated into a
dosage form, many factors must be considered.
• These can be broadly grouped into three categories:
biopharmaceutical considerations
including factors affecting the absorption of the drug substance from different
administration routes
Drug factors
such as the physical and chemical properties of the drug substance
Therapeutic considerations
Including consideration of the clinical indication to be treated and patient factors.
• High-quality and efficacious medicines will be formulated and prepared only when all
these factors are considered and related to each other. This is the underlying
principle of dosage form design.

14. Dosage forms
• Solid dosage forms e.g tablets, capsules, powders,
• Semi-solid dosage forms e.g creams
• Liquid dosage forms
1. Solutions e.g Injectable (parenteral) drugs
2. Emulsions e.g Calamine lotion
3. Suspensions e.g Amoxicillin suspension

15. THANK YOU
THE END