PHARMACEUTICAL DOSAGE FORM, DRUG DELIVERY SYSTEMS AND MEDICAL DEVICES LABORATORY

MODULE 1

PHARMACEUTICS

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

DRUG

Maybe defined as an agent intended for use in diagnosis, mitigation, treatment, cure and prevention of disease in man or animal

PHARMACEUTICAL PREPARATIONS

are dosage forms in which drugs are prepared by the pharmacists for internal and external administration in the treatment of disease.

DOSAGE FORMS

Known as pharmaceuticals

PHARMACEUTICAL PREPARATIONS

This may be done extemporaneously compounded by a pharmacist or manufactured for immediate distribution

DOSAGE FORMS

Prepared by adding an active ingredients and non-active ingredient

ACTIVE INGREDIENTS

active pharmaceutical ingredients (API); therapeutic ingredients; Pharmacologically active

NON-ACTIVE INGREDIENTS

Inert; inactive ingredients; additives; excipients

MANUFACTURING

Means the production, preparation, propagation, conversion, or processing of a drug or device, either directly of indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis

COMPOUNDING

The preparation of components into a drug product

COMPOUNDING

As the result of a practitioner’s prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional practice

COMPOUNDING

For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing

UNITED STATES PHARMACOPEIA COMPOUNDING

is the preparation, mixing, assembling, altering, packaging and labeling of a drug, drug delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional Practice

CONTAINERS

according to USP and NF, it is a device that holds a drug and is or may be, in direct contact with the drug.

IMMEDIATE CONTAINERS

is that which is in direct contact with the drug at all times.

WELL CLOSED CONTAINER

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

TIGHT CONTAINER

Protects the content from contamination by extraneous liquid, solid or vapors from loss of the drug and from efflorescence or evaporation under usual condition of handling, shipment, storage and distribution

HERMETIC CONTAINER

Impervious to air or any gas under ordinary or customary condition usually injectables and parenterals

SINGLE DOSE CONTAINER

Intended for single dose; once opened it cannot be resealed

MULTIPLE DOSE CONTAINER

it permits withdrawal of successive portions of the contents without changing the strength of the remaining portion

ROUND BOTTLE

used primarily for solid dosage forms; capsule and tablets

RX BOTTLE

used for dispensing liquids of low viscosity

WIDE MOUTH BOTTLE

used for bulk powders; Large quantities of tablets and capsules and viscous liquids that cannot be poured readily from the narrow neck standard Rx bottle

OINTMENT JAR/COLLAPSIBLE TUBE

used to dispense semi-solid dosage forms, such as ointments and creams

DROPPER BOTTLE

used for dispensing ophthalmic, nasal, otic and oral liquid to be administered by drops

APPLICATOR BOTTLE

used for applying liquid medication to a wound or skin surface

SIFTER-TOP CONTAINER

used for powders to be applied by sprinkle

HINGED OR SLIDE BOXES

used for dispensing supp/ powder prepared in packets

AEROSOL CONTAINERS

for aerosol products

SOLID/LIQUIDS/SEMI-SOLID (NARROW/ WIDE-MOUTH ROUND BOTTLES)

SOLID (RESEALABLE PLASTIC)

SEMI-SOLID (COLLAPSIBLE TUBE – OINTMENT/PASTE)

SEMI-SOLID (OINTMENT JAR – CREAMS/OINTMENTS)

STORAGE

labelling includes desired condition of storage to ensure the stability of a pharmaceutical preparation for the period of its intended shelf life

STABILITY

refers to the maintenance of the original, physical, chemical and therapeutic properties over an extended period of time or until expiry date

PHYSICAL STABILITY

original physical properties including appearance, palatability, uniformity, dissolution, and suspendability are retained

CHEMICAL STABILITY

active ingredients retain its chemical integrity and labelled potency within the specified limits

MICROBIOLOGICAL STABILITY

sterility or resistance to microbial growth is retained according to the specified requirements.

MICROBIOLOGICAL STABILITY

Antimicrobial agents that are present retain effectiveness within specified limits

THERAPEUTIC STABILITY

therapeutic effect remains unchanged

TOXICOLOGICAL STABILITY

no significant increase in toxicity occurs

NOT EXCEEDING 8°C

STORAGE REQUIREMENT: TEMP

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COLD

BETWEEN 8-15°C

STORAGE REQUIREMENT: TEMP

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COOL

ROOM TEMPERATURE

the temp prevailing in working area

15-30°C

STORAGE REQUIREMENT: TEMP

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CONTROLLED ROOM TEMPERATURE

25°C

STORAGE REQUIREMENT: TEMP

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OFFICIAL ROOM TEMPERATURE

BETWEEN 30-40°C

STORAGE REQUIREMENT: TEMP

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WARM TEMPERATURE

ABOVE 40°C

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STORAGE REQUIREMENT: TEMP

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EXCESSIVE HEAT

SHELF LIFE

Refers to the length of time that a drug produced may remain on the pharmacist’s shelf in the original packages and under usual environmental condition

SHELF LIFE

Retain an acceptable level of its original potency and overall quality

SHELF LIFE

If storage condition are not met, either physical degradation or chemical deterioration may occur

SOLID DOSAGE FORMS

shelf life 5yrs from the date of preparation

LIQUID DOSAGE FORMS

shorter shelf life

NOT BEYOND 6 MONTHS

EXTEMPORANEOUS PREPARATION:

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Non- aqueous liquids & solids

NOT LATER THAN 14 DAYS

EXTEMPORANEOUS PREPARATION:  

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Water containing prep. in solid form (tablet/capsules)

NOT LATER THAN 30 DAYS

EXTEMPORANEOUS PREPARATION:  

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all other preparations

EXPIRATION DATE

Latest date at which the product is expected to be stable physically, chemically, therapeutically, identity, strength, quality and purity until that date if storage condition are met

NON PROPRIETARY OR PUBLIC NAME

* Generic name
* denoting a drug name, usually descriptive of the drug’s chemical structure

PROPRIETARY NAME

* brand name/trade name
* given by the manufacturer or distributor

OVER THE COUNTER

drugs which are deemed safe enough for use by the laymen in the self treatment of simple conditions

OVER THE COUNTER

sold without Rx

LEGEND DRUGS

are those which are considered to be useful only after expert diagnosis and dangerous for use in self-medication

DANGEROUS DRUGS

uses Yellow Prescription

PER-ORAL ROUTE

swallowing by mouth

PARENTERAL ROUTE

injected into the body alimentary canal

RECTAL ROUTE

inserted or injected into the rectum

TOPICAL ROUTE

applied to a certain area of the skin

VAGINAL ROUTE

supp (Pessaries)

INHALATION ROUTE

drugs are inhaled by the nose or mouth; used for the treatment of respiratory condition

ORAL ROUTE

not swallowed; drug are allowed to be dissolved in the oral cavity

SUBLINGUAL

under the tongue

BUCCAL

cheeks

PERLINGUAL

mouth