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Pharmaceutics Basic Notes

Pharmaceutics is the science of designing dosage forms, encompassing drug formulation, manufacturing, stability, drug delivery systems, and regulatory compliance. Key stages in drug development include preformulation studies, formulation, manufacturing, and packaging, with various dosage forms such as solids, liquids, semisolids, and parenterals. Recent trends involve advancements like nanoparticles for targeted delivery, controlled release systems, and 3D printing of personalized medicines.

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649 views4 pages

Pharmaceutics Basic Notes

Pharmaceutics is the science of designing dosage forms, encompassing drug formulation, manufacturing, stability, drug delivery systems, and regulatory compliance. Key stages in drug development include preformulation studies, formulation, manufacturing, and packaging, with various dosage forms such as solids, liquids, semisolids, and parenterals. Recent trends involve advancements like nanoparticles for targeted delivery, controlled release systems, and 3D printing of personalized medicines.

Uploaded by

amanfatima
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd

📚 Pharmaceutics – Basic Notes

1. Definition

Pharmaceutics is the science of dosage form design — it covers the process from discovering a
drug to turning it into a safe, effective, and acceptable medicine for patient use.

2. Scope

 Formulation Development – designing tablets, capsules, injections, creams, etc.

 Manufacturing – large-scale production with quality control.

 Stability – ensuring the drug remains effective and safe until its expiry date.

 Drug Delivery Systems – improving how drugs reach their target in the body.

 Regulatory Compliance – meeting pharmacopeia and government requirements.

3. Key Stages in Drug Development

1. Preformulation Studies

o Identify physicochemical properties: solubility, stability, pKa, partition


coefficient.

o Understand compatibility with excipients.

2. Formulation

o Active Pharmaceutical Ingredient (API) – the drug itself.

o Excipients – inactive substances added for stability, taste, or manufacturability


(binders, fillers, disintegrants, lubricants, preservatives).

3. Manufacturing

o Mixing, granulation, compression, coating (for tablets).

o Sterilization (for injectables).

o Quality checks at each stage.

4. Packaging

o Protects from light, moisture, oxygen.


o Provides patient information.

4. Dosage Forms

Solid

 Tablets, capsules, powders, granules.

 Advantages: stability, accurate dosing, easy packaging.

 Disadvantages: slower onset vs. liquids, swallowing difficulty.

Liquid

 Solutions, suspensions, emulsions, syrups.

 Advantages: faster absorption, easier for children/elderly.

 Disadvantages: less stable, heavier to transport.

Semisolid

 Ointments, creams, gels, pastes.

 For topical/local effect.

Parenteral

 Injections (IV, IM, SC), infusions.

 Rapid onset, used when oral is not possible.

5. Routes of Drug Administration

1. Oral – convenient but affected by first-pass metabolism.

2. Parenteral – bypasses GIT, rapid effect.

3. Topical – local or transdermal delivery.

4. Inhalation – lungs as route (e.g., asthma inhalers).

5. Rectal/Vaginal – for local or systemic use.

6. Good Manufacturing Practices (GMP)


 Controlled environment (temperature, humidity).

 Trained personnel.

 Documentation of every batch.

 Validation of processes.

7. Stability Factors

 Physical: moisture, light, temperature.

 Chemical: hydrolysis, oxidation.

 Microbiological: contamination risks.

 Controlled via proper formulation, antioxidants, preservatives, desiccants, refrigeration if


needed.

8. Bioavailability & Bioequivalence

 Bioavailability – fraction of drug that reaches systemic circulation.

 Bioequivalence – two products with similar bioavailability & effect.

9. Quality Control Tests

 For tablets: hardness, friability, disintegration time, dissolution rate, weight variation.

 For capsules: weight variation, disintegration, dissolution.

 For liquids: viscosity, pH, microbial limit.

 For parenterals: sterility, pyrogen testing, particulate matter.

10. Recent Trends in Pharmaceutics

 Nanoparticles – targeted delivery.

 Controlled release – maintain steady drug levels.

 Orally disintegrating tablets (ODTs) – for patient convenience.


 3D printing of medicines – personalized doses.

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