1. Presented By
Dileep Singh Baghel
Asst. Professor, LSPS, LFAMS
Lovely Professional University, Punjab
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2. Pharmaceutical Industry
Customers
Pharmaceutical
Industry
Medicines
Main
Patient
Return
Documents
Regulatory
Agencies

3. From Molecule to Patient
Therapeutic
Target
Discovery/
Literature
serve
Patient
Distribution
Research and
Development
Final Dosage
form
Approval
Manufacture

4. By which drug molecules are
delivered to sites of action
within the body is c/a Dosage
form.

5. Mechanism for safe and convenient delivery
of accurate dosage.
Protection of drug from atmosphere or
increasing self life of drugs.
Masking taste and odour.
Delivering the drugs within body tissues.
Sustained release medication.
Controlled release medication.
Optimal drug action or Improving ADME of
the drugs.

6. Classification of dosage forms :
They are classified according to:
Route of administration
Oral
Topical
Rectal
Parenteral
Vaginal
Inhaled
Opthalmic
Physical form
Solid
Semisolid
Liquid
Gaseous

7. Pharmaceutics
Active Ph. Ingredients
Pharmacokinetics
Pharmacodynamic
Adverse Effects
Business & Economics
Governmental Regulation
Therapeutic usage/ Equivalence
Pharmaceutical Equivalence
Bioequivalence
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8. Pharmaceutics is the science of dosage
form design.
There are many chemicals with known
pharmacological properties but in a raw
form it is worth less for patient.
Pharmaceutics
deals
with
the
formulation of a pure drug substance
into a dosage form.
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9. Drugs or Active Ph. Ingredient
ACTIVE
PHARMACEUTICAL
INGREDIENT
PROVIDES THE THERAPEUTIC EFFECT
ACTIVE PHARMACEUTICAL INGREDIENTS =
DRUG SUBSTANCES

10. API
+
EXCIPIENTS
ACTIVE
INERT
DOSAGE FORM

11. Effectiveness
Safety
Reliability
Stability
Physical
Chemical
Microbiological

12. Pharmaceutical elegance
Appearance
Organoleptic properties
Convenience
Ease of use
Dosing frequency
Consumer acceptance

13. Excipients may be added to protect the
drug
Antioxidants
Preservatives
Chelating agents
Buffering agents

14. Therapeutic usage Determining
which
diseases
are
approved to be treated by a drug
Discovering how a drug works to achieve
its therapeutic activity
Finding the recommended dosage and
route administration of a drug
Learning how a drug is absorbed,
distributed, metabolized, and excreted

15. List of possible unpleasant or dangerous
secondary effects other than the desired
effects
Causes of ADRs Interactions
Drug/Drug
Drug/Food
Drug/Herb
Toxic potential

16. Business & Economics
Drug prices
Drug sales
Drug companies
Drug Manufacturers
Drug Stores
Most commonly prescribed drugs

17. Government regulation
Drug approval process.
Identifying
which
countries
have
approved the usage of a specific drug.
The restriction or prohibition of the
usage of specific drugs (controlled
substances)
Policies and codes regulating the
manufacture, distribution, and sales of
pharmaceutical agents

18.  Pharmaceutical Equivalence
 Same active ingredient.
 Same strength.
 Same dosage form and route of administration.
 Comparable labeling
 Meet compendial or other standards of identity,
strength, quality, purity and potency
 Bioequivalence
 In vivo measurement of active moiety (moieties) in
biologic fluid (blood/urine)
 In vivo pharmacodynamic comparison
 In vivo clinical comparison
 In vitro comparison
 Therapeutic Equivalence

19. Standardization & Quality Evaluation
• Colour
• Odour
• Taste
• Texture
•
Fracture
•Shape
• Quantitative
•External
Macroscopic
•Marking
Microscopic
QUALITY EVALUATION
OF HERBAL DRUGS
Microbial
Contamination
BI
OL
OG
IC
AL
• Other specific
activities
•Qualitative
Antagonistic
• Bacterial
• Fungal
• Powder Studies
• Moist. Cont.
• Extrac. Values
• Ash Values
• Fluores. Analy.
AL
EMIC
CH
• Toxicological
• Pharmacological
• SEM Studies
BOTA
N IC A
L
PHYSICAL
PHYSICAL
C
TI
P
LE
NO
A
G
R
O
• Qualitative
HPTLC
GLC
HPLC
• Quantitative
• Chromatography
• Heavy metal
• Pesticide residue
• Mycotoxin
HPTLC Finger printing
Sec. Metabolites
DNA Finger printing

20. Thank You