DOSAGE - Module 1

Pharmaceutics

The study that concerns itself with the physical, chemical, and biological factors influencing the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms.

Drug

Agent intended for use in diagnosis, mitigation, treatment, cure, and prevention of disease in man or animal.

Pharmaceutical Preparations

Dosage forms in which drugs are prepared by pharmacists for administration in the treatment of disease; can be compounded extemporaneously or manufactured.

Dosage Forms

pharmaceuticals, prepared by adding an active pharmaceutical ingredient (API) and inactive ingredients (excipients) forming the vehicle or formulation matrix.

Manufacturing

Production, preparation, propagation, conversion, or processing of a drug/device by extraction from natural substances or through chemical/biological synthesis.

Compounding

Preparation of components into a drug product as a result of a practitioner’s prescription, research, teaching, or chemical analysis, not for sale or dispensing.

Reasons for Compounding

Patients may need dosages or forms not commercially available, be allergic to excipients, require pediatric formulations, need stable preparations, require veterinary drugs, or benefit from innovative delivery forms.

Well-Closed Container

Protects the content from extraneous solids and from loss of the article under ordinary handling, shipment, storage, and distribution conditions.

Tightly Closed Container

Protects contents from contamination by extraneous liquids, solids, or vapors and prevents loss or evaporation; capable of tight re-closure.

Efflorescence

Loss of water

Deliquiscent

Liquification of a solid due to gain of moisture

Hermetic Container

Impervious to air or other gases under normal handling; intended for injection or parenteral preparation.

Light-Resistant Container

Protects contents from the effects of light.

Amber Bottles

Example of Light-Resistant Container

Child-Resistant Container

Designed to prevent access by children.

Tamper-Proof Container

Shows visible evidence if tampered with.

Single Dose Container

unit dose package; holds a single quantity of drug that cannot be resealed with sterility assurance.

Ampules and prefilled syringes.

Examples of Single Dose Container

Multiple Dose Container

Contains more than one dose, allowing withdrawal of successive portions without compromising strength, quality, or purity.

Vials and Bottles

Examples of Multiple Dose Containers

Round Bottle

Used primarily for liquid dosage forms.

Applicator Bottle

Used for applying liquid medication to a wound or skin surface.

Rx Bottle

Used for dispensing low viscosity liquids.

Sifter-Top Container

Used for powders to be applied by sprinkling.

Wide Mouth Bottle

Used for bulk powders and large quantities of tablets or capsules.

Dropper Bottle

Used for ophthalmic and otic preparations.

Aerosol Container

Used to dispense liquid contents as a mist or foam.

Collapsible Tube/Ointment Jar

Used to dispense semi-solid dosage forms like ointments and creams.

Manufacturer's Label Information

Includes generic name, brand name, use, quantity, dosage strength, dose, storage condition, formulations, special instructions, manufacturer information, expiry date, manufactured date, lot number, registration number.

Extemporaneous Label Information

Includes patient name, pharmacy details, date of preparation, product name or description, active substances with strength and quantity, total quantity, directions, route of administration, warnings, expiry date, storage instructions, and batch number if applicable.

Shelf Life

The length of time a drug may remain on the shelf retaining acceptable potency and quality under usual storage conditions.

Expiry Date/ Beyond Use Date

The latest date at which the product is expected to remain stable physically, chemically, and therapeutically under proper storage conditions.

Non-Proprietary Name

The generic name of a drug.

Proprietary Name

The dor trade name of a drug.

Over the Counter (OTC) Drugs

Drugs that can be purchased without a prescription.

Legend Drugs

Ethical drugs that require a prescription and carry the label Rx.

Dangerous Drugs

Drugs regulated by special prescriptions (yellow forms) due to potential misuse or abuse.

S2 License

License level to be authorized to prescribe Dangerous Drugs

The Dangerous Drug Board

DDB; oversees the dangerous drugs distribution

Routes of Administration

The path by which a drug is taken into the body

Per-Oral

Taken by mouth and swallowed.

Parenteral

Injected into the body

Rectal

Placed in the rectum

Topical

Applied on the skin

Vaginal

Placed inside the vagina.

Inhalation

Breathed in through the mouth or nose.

Sublingual

Placed under the tongue to dissolve

Buccal

Placed between the cheek and gum to dissolve.

Perlingual

Applied directly on the tongue.

Cold Storage

Storage condition not exceeding 8°C.

Cool Storage

Storage between 8 - 15°C.

Controlled Room Temperature

Storage between 15 - 30°C

official room temperature

Storage with 25°C.

Warm Temperature

Storage between 30 - 40°C.

Excessive Heat

Storage condition above 40°C.

Physical Stability

Refers to stability in appearance, palatability, uniformity, dissolution, and suspendability.

Chemical Stability

Refers to chemical integrity and potency retention.

Microbiological Stability

Refers to resistance against microbial contamination.

Therapeutic Stability

Ability to retain therapeutic effect.

Toxicological Stability

Ensures no increase in toxicity during storage.