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
COLD
BETWEEN 8-15°C
STORAGE REQUIREMENT: TEMP
COOL
ROOM TEMPERATURE
the temp prevailing in working area
15-30°C
STORAGE REQUIREMENT: TEMP
CONTROLLED ROOM TEMPERATURE
25°C
STORAGE REQUIREMENT: TEMP
OFFICIAL ROOM TEMPERATURE
BETWEEN 30-40°C
STORAGE REQUIREMENT: TEMP
WARM TEMPERATURE
ABOVE 40°C
STORAGE REQUIREMENT: TEMP
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:
Non- aqueous liquids & solids
NOT LATER THAN 14 DAYS
EXTEMPORANEOUS PREPARATION:
Water containing prep. in solid form (tablet/capsules)
NOT LATER THAN 30 DAYS
EXTEMPORANEOUS PREPARATION:
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