MOD 1 PHARMACEUTICS Flashcards
Study that concern itself with the physical, chemical and biological factors which influenced the formulation, manufacture, stability and effectiveness of pharmaceutical dosage forms
PHARMACEUTICS
an AGENT intended for use in diagnosis, mitigation, treatment, cure and prevention of disease in man or animal
DRUG
Are dosage forms in which drugs are PREPARED BY THE PHARMACISTS for administration in the treatment of disease
This may be done extemporaneously compounded or manufactured for immediate distribution
PHARMACEUTICAL PREPARATIONS
DOSAGE FORMS are also known as
PHARMACEUTICALS
It is prepared by adding an ACTIVE ingredient and a NON-THERAPEUTIC ingredient usually called as excipients which comprises a vehicle or formulation matrix
DOSAGE FORMS / PHARMACEUTICALS
active ingredients are also known as
active pharmaceutical ingredients (API), therapeutic ingredients, or Pharmacologically active
non-therapeutic ingredients are also known as
INERT / INACTIVE ING.
inactive ingredients are usually called as
EXCIPIENTS
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
MANUFACTURING
The PREPARATION OF COMPONENTS into a drug product;
(1) As the result of a practitioner’s prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional practice, or
(2) For the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing
COMPOUNDING
(according to what)
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
UNITED STATES OF PHARMACOPEIA (USP CHAP 795)
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
COMPOUNDING
Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a _______________ relationship exists and a valid prescription is presented
PHARMACIST-PATIENT-PRESCRIBER
Pharmacists may compound, in reasonable quantities, drug preparations that are commercially available in the marketplace if a pharmacist–patient–prescriber relationship exists and a _________ is presented
VALID PRESCRIPTION
Pharmacists may compound nonprescription medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by ______________ of pharmacy.
INDIVIDUAL STATE BOARDS
Pharmacists may compound _________ medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by individual state boards of pharmacy.
NONPRESCRIPTION
Pharmacists should NOT OFFER compounded medications to _________ for resale
OTHER PHARMACIES
a practitioner may obtain compounded medication to administer to patients, but it should be labeled with:
(6)
For office use only
date compounded
use-by date
name
strength
quantity of active ingredients
Compounding pharmacies and pharmacists may _____ or otherwise ________ the fact that they provide prescription compounding services
advertise / promot
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Many patients need drug dosages or strengths that are ______________
NOT COMMERCIALLY AVAILABLE
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Many patients are ______ to excipients in commercially available products
ALLERGIC
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
__________ must be prepared as liquids, flavored to enhance compliance, and prepared in alternative dosage forms, such as lozenges, gumdrops, popsicles, and lollipops.
CHILDREN’S MEDICATIONS
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Some medications are not very _____ and require preparation and dispensing EVERY FEW DAYS; they are NOT SUITABLE TO BE MANUFACTURED products.
STABLE
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Many physicians desire to deliver products in ________ ways, and pharmacists can work with them to solve medication problems
INNOVATIVE
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Most products are not available for _________ patients and must be compounded.
VETERINARY
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
_________ has resulted in new approaches to pain management and higher concentrations and combinations of drugs that are now used
HOSPICE CARE
REASONS why pharmacists have increased the practice of compounding patient-specific medications:
Many drugs are reported in the literature but are _____________, so pharmacists can compound them for their physicians’ and patients’ use
NOT YET MANUFACTURED
Devised to make possible the administration of medication in measured prescribed amount
DOSAGE FORMS / PHARMACEUTICS
Steps in Compounding
- Calculation
- Prepare/Weigh/Measure ingredients
- Prepare the label/Select appropriate container
- Compounding
- Packaging/Labeling
- Submit worksheet and the product
device that HOLDS A DRUG and is or may be, IN DIRECT CONTACT with the drug
CONTAINERS
in direct contact with the drug AT ALL TIMES; e.g. closure
IMMEDIATE CONTAINER
Types of container According to Their Ability to Protect their Contents from External Conditions
Well-closed
Tightly-closed
Hermetic container
Light-resistant
Child-resistant
Tamper-proof container
Types of container According to Content or Capacity
Single Dose
Multiple Doses
It protects the content from EXTRANEOUS SOLIDS and from loss of the article under ordinary conditions of handling, shipment, storage and distribution
WELL-CLOSED CONTAINER
It protects the contents from CONTAMINATION by extraneous liquids, solids or vapors, from loss of the article and from efflorescence, deliquescence or evaporation under the ordinary or customary conditions of handling, shipment, storage and distribution and is CAPABLE OF TIGHT RECLOSURE
TIGHTLY-CLOSED CONTAINER
It is IMPERVIOUS TO AIR or any other gas under the ordinary or customary conditions of handling, shipment, storage and distribution; Intended for INJECTION or PARENTERAL preparation
HERMETIC CONTAINER
Known as UNIT DOSE PACKAGE; One that holds a quantity of drug intended as a single dose and when opened CANNOT BE RESEALED with assurance that sterility has been maintained
Examples: [Ampules, Prefilled syringes or cartridges, Blister pack, Foil]
SINGLE DOSE CONTAINER
One that contains MORE THAN A SINGLE DOSE of the medication and permits the withdrawal of successive portions without changing the strength or endangering the quality or purity of the remaining portion
Examples: [Vials; Bottles]
MULTIPLE DOSE CONTAINER
Used primarily for LIQUID DOSAGE FORMS
ROUND BOTTLE
Used for dispensing liquids of LOW VISCOSITY
Rx BOTTLE
Used for BULK POWDERS; large
quantity of tablets/capsules
WIDE MOUTH BOTTLE
Used for applying LIQUID MEDICATION to a wound or skin surface
APPLICATOR BOTTLE
Used for powders to be APPLIED BY SPRINKLE
SIFTER-TOP CONTAINER
Used for OPHTHALMIC and OTIC preparation
DROPPER BOTTLE
Used to dispense SEMI-SOLID dosage forms
OINTMENT JAR, COLLAPSIBLE TUBE
Used to dispense liquid contents as a MIST or FOAM
AEROSOL CONTAINER
RULES IN LABELLING
Label on immediate container
Package inserts
Company literature
Advertising and promotional materials
MANUFACTURER’S LABEL INFORMATION
– Generic name
– Brand name
– Use
– Quantity
– Dosage strength
– Dose
– Storage condition
– Formulations
– Special instructions
– Manufacturer’s information
– Expiry date
– Manufactured date
– Lot/Batch number
– Registration number
labelling includes desired condition of _________ to ENSURE STABILITY of a pharmaceutical preparation for the period of its intended shelf life
STORAGE
5 Types of Stability
– Physical
– Chemical
– Microbiological
– Therapeutical
– Toxicological
Type of STABILITY:
– Appearance, palatability, uniformity, dissolution, suspendability
PHYSICAL
COLD
not exceeding 8°C
COOL
between 8 - 15°C
Controlled Room Temperature
15 - 30°C
Official Room Temp
25°C
WARM TEMP
between 30 - 40°C
EXCESSIVE HEAT
above 40°C
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
SHELF LIFE
Solid dosage forms (Tab & Cap) SHELF LIFE
5yrs from the date of preparation
Liquid dosage forms; dispersed systems-aerosols, emulsions; semi-solid (Oint & Supp)
SHORTER SHELF LIFE
SHELF LIFE:
Non-preserved aqueous
14 DAYS
SHELF LIFE:
Preserved aqueous
35 DAYS
SHELF LIFE:
Nonaqueous
90 DAYS
SHELF LIFE:
Solid dosage forms
180 days
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
EXPIRY DATE / BEYOND USE DATE
Non-proprietary name
GENERIC NAME
Proprietary name
BRAND NAME, TRADE NAME
Classification of Drugs
– OTC (Over the Counter)
– Legend Drugs-ethical drug
– Dangerous Drugs
use of yellow prescription
DANGEROUS DRUGS
TYPES OF DANGEROUS DRUGS
PROHIBITED
REGULATED
ethical drug
LEGEND DRUGS
has label Rx
LEGEND DRUGS
Swallowing via mouth
PER-ORAL
Injected into the body
PARENTERAL
Inserted into the rectum
RECTAL
Applied to a certain area of the skin
TOPICAL
Inserted into the vagina
VAGINAL
inhaled through mouth or nose
INHALATION
under the tongue
SUBLINGUAL
beside the cheek
BUCCAL
administered by application to the tongue (tip)
PERLINGUAL
