Upload
9219605899
View
386
Download
2
Embed Size (px)
DESCRIPTION
Citation preview
Presented ByDileep Singh BaghelAsst. Professor, LSPS, LFAMS
Lovely Professional University, Punjab1
Pharmaceutical Industry Main Customers
Medicines
Return
Documents
Patient
Regulatory Agencies
Pharmaceutical Industry
From Molecule to PatientDiscovery/ Literature
serve Research and Development Approval
ManufactureDistribution
Therapeutic Target
Final Dosage formPatient
By which drug molecules are delivered to sites of action within the body is c/a Dosage form.
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.
They are classified according to:
Route of administration Physical form
Oral Solid Topical
Semisolid Rectal Liquid Parenteral Gaseous Vaginal Inhaled Opthalmic
Classification of dosage forms :
PharmaceuticsActive Ph. IngredientsPharmacokineticsPharmacodynamicAdverse EffectsBusiness & EconomicsGovernmental RegulationTherapeutic usage/ EquivalencePharmaceutical EquivalenceBioequivalence
7
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.
8
ACTIVEPHARMACEUTICA
LINGREDIENT
Drugs or Active Ph. Ingredient
PROVIDES THE THERAPEUTIC EFFECT
ACTIVE PHARMACEUTICAL INGREDIENTS = DRUG SUBSTANCES
+API
DOSAGE FORM
EXCIPIENTS
INERTACTIVE
EffectivenessSafetyReliabilityStability
PhysicalChemicalMicrobiological
Pharmaceutical eleganceAppearanceOrganoleptic properties
ConvenienceEase of useDosing frequencyConsumer acceptance
Excipients may be added to protect the drugAntioxidantsPreservativesChelating agentsBuffering agents
Therapeutic usage -Determining which diseases are
approved to be treated by a drugDiscovering how a drug works to
achieve its therapeutic activityFinding the recommended dosage
and route administration of a drugLearning how a drug is absorbed,
distributed, metabolized, and excreted
List of possible unpleasant or dangerous secondary effects other than the desired effects
Causes of ADRs - Interactions
Drug/DrugDrug/FoodDrug/Herb
Toxic potential
Business & EconomicsDrug pricesDrug salesDrug companies
Drug ManufacturersDrug Stores
Most commonly prescribed drugs
Government regulationDrug 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
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
QUALITY EVALUATION QUALITY EVALUATION OF HERBAL DRUGSOF HERBAL DRUGS
CHEMICALCHEMICAL
BIOLOGICAL
BIOLOGICAL
ORGANOLEPTIC
ORGANOLEPTIC BOTANICALBOTANICAL
PHYSIC
AL
PHYSIC
AL
• Moist. Cont.• Extrac. Values• Ash Values• Fluores. Analy.
Macroscopic Microscopic
• Qualitative • Quantitative• SEM Studies • Powder Studies
•Shape•External•Marking
• Colour • Odour• Taste• Texture • Fracture
Antagonistic
Microbial Contamination
• Toxicological• Pharmacological • Other specific activities
• Bacterial• Fungal
•Qualitative• Quantitative • Chromatography• Heavy metal • Pesticide residue• Mycotoxin
HPTLC GLC HPLC
HPTLC Finger printing Sec. Metabolites DNA Finger printing
Standardization & Quality Evaluation
Thank You