DRUG ■ Faster absorption than oral

due abundance of blood

● For the diagnosis, cure, mitigation, vessels present
treatment, or prevention of disease ○ Rectal
● Recognized by monograph (USP) ■ Used usually on babies
● Used to affect the structure or function of ● Parenteral Administration
the body ○ Subcutaneous (SC, DQ)
● Used as component of previous definitions ■ Adipose layer
■ Ex. insulin
ACTIVE INGREDIENT ○ Intramuscular (IM)
■ Usually for oil soluble drugs
● Any component intended to furnish ■ Vaccines
pharmacological activity or other direct ○ Intradermal (ID)
effect ■ Dermis
● Includes components that may undergo ■ Allergen testing
chemical change ○ Intraperitoneal (IP)
● Ex. Enalapril - active pharmaceutical ■ Peritoneal/peritoneum
ingredient but is not the one that acts in ○ Intraocular (IO)
the body ■ Eyes
■ dilatants
ROUTE: INTRAVASCULAR ADMINISTRATION ○ Intrathecal (IT)
■ Directly to the spinal fluids
● Intravenous (IV) ■ Anaesthesia for giving birth
○ Directed directly into a vein ● Others
■ Bolus - one big dose ○ Inhalation
■ Infusion ■ Asthma
● Intermittent - ■ Respiratory drugs
scheduled ○ Topical
● Continuous ■ Ointments, skin
● Intraarterial (IA) ■ Wound or skin allergies
○ Injected into an artery ○ Transdermal
● Intracardiac (IC) ■ Skin
○ Injected into the heart chamber ■ For systemic absorption
○ Intranasal
ROUTE: EXTRAVASCULAR DRUG ■ Nose
ADMINISTRATION ○ Intravaginal
■ Vagina
● Enteral Administration ○ Urethral
○ Oral ■ Urethra
○ Buccal ○ Otic
■ into the buccal cavity
(cheeks) DOSAGE FORMS
■ Faster absorption than oral
due abundance of blood ● Means of administering drugs
vessels present ● Importance:
○ Sublingual ○ Protect drug substance from
environment and prolong shelf life
 ○ Protect the drug substance from
atmospheric oxygen or humidity
■ Coated tablets
■ Sealed ampoules
■ Ex. Aspirin - in powder
form, easily degrades to
acetic acid by atmospheric
oxygen and humidity
○ Protects the drug from destructive
influence of gastric acid
■ Enteric-coated tablet
○ Conceal bitter, salty, or offensive
taste or odor of drug substance
■ Capsules
■ Coated tablets
■ Flavored syrups
○ Provide liquid preparation of drug
substances, either dispersions or
clear preparations
○ Provide rate-controlled drug action
■ Controlled-release tablets
■ Capsules
■ Suspensions
○ Provide optimal drug action from
topical administration sites
■ Ointments
■ Creams
■ Transdermal patches
■ Ophthalmic, ear, and nasal
preparations
○ Provide insertion of drug into one
of the body’s orifices
■ Rectal or vaginal
suppositories
○ Provide placement of drugs directly
in the bloodstream or body tissues
■ Injections
○ Provide optimal drug action
through inhalation therapy
■ Inhalants
■ Inhalation aerosols
■ Ex. salbutamol - asthma
HISTORY OF DOSAGE FORM DESIGN
● Primitive
○ Lacked consistency, uniformity,
specificity
○ Chewing medical part, inhaling
soot, taking medicinal extracts
● First Generation
○ End of 18th Century
○ Have consistency and uniformity
○ Conventional tablets, capsules,
elixirs, syrups, suspension,
solutions, etc.
● Second Generation
○ 1950s
○ Modified to protect drug, prolong
action, improve bioavailability
○ Enteric coated tablets
● Third Generation
○ Mid-1960s
○ Controlled drug delivery systems
○ Osmotically-controlled, diffusion
controlled, electrically controlled,
etc.
● Fourth Generation
○ Control on the time availability and
localization of the drug in the body
○ Targetable (site-specific)
○ Modulated (pulsatile - released at
certain times)
○ self -regulated (feedback controlled
- reaches
● Fifth Generation
○ Gene therapy
○ Treat the cause of a disease
CATEGORY OF DOSAGE FORMS
● Based on delivery route
○ GI Tract
■ Oral, oropharyngeal, rectal
○ Tissues or Body Fluids
■ IV, IA, IC, IM, etc.
○ Mucosal Membrane
■ Otic, nasal, ophthalmic,
vaginal, urethral
○ Skin surface
■ Topical , transdermal
○ Lungs
■ Inhalation
 ● Based on release pattern something to
○ Conventional release produce a large
○ Modified release scale manufacturing
■ Extended ■ Co-solvents, solubilizers,
■ Delayed emulsifiers, diluent, binders,
■ Targeted suspending agents
■ Pulsatile ○ Added for acceptability
■ Orally disintegration ■ Increase patient
■ Orally dipersing acceptability of the drug
product
EXCIPIENT ■ Flavors, colors, sweetening
agent, etc.
● Any component other than active
ingredient in a drug products PACKAGING, LABELING AND STORAGE OF
● Inactive ingredient PHARMACEUTICAL
● Qualities:
○ Harmless in amounts used ● Packaging
○ Does not exceed the minimum ○ Economical means of providing
quantity required to provide ■ Presentation
intended effect ■ Protection
○ Does not impair bioavailability or ■ Identification
efficacy of dosage form ■ Containment
■ Bioavailability - level of drug ■ Convenience
absorbed in the body ■ Compliance
○ Does not interfere with assays and ○ Primary
tests prescribed for determining ■ Immediate container
their compliance of official ■ Direct contact with product
standards ■ Contain product
■ Ex. titrations - excipient ○ Secondary
should not hinder the __ of ■ Outer packaging
API ■ Additional physical
● Categories of Excipients protection - ensure the safe
○ Added for stability storage and delivery
■ Enhances physical and ○ Container - holds the drug
chemical stability of drugs ○ Liner - effects a hermetic seal
■ Buffers, preservative between the closure and container
○ Added for in vivo absorption ○ Inner seal - for a more positive seal
■ Improves capability of the surface and to provide
drug substance to reach tamper-evidence
general circulation ○ Coil- prevents damage during
○ Added for manufacturability shipping
■ Promotes production of the ○ Desiccant - counteracts moisture
drug substance into dosage brought by the coil
form ○ Cap or closure - provide an
● Ex. Cetirizin (for effective seal
allergies) - 10 mg, ■ Screw, threaded, lug,
furmulator adds crimp-on, crown, etc.
 ○ Insert, boxes, catons, corrugated ● Treated soda-lime
shippers, pallets glass
● Protection ability ● For acidic solutions
○ Well-close container ■ Type III
■ Protects against extraneous ● Soda -lime glass
solids and loss of drugs ● Dry powder
under ordinary conditions substances
○ Tight container ■ Type NP
■ Protects against extraneous ● Plastic
solids, liquids or vapors, ○ Advantages:
loss of drug, etc. ■ Light-weight
○ Hermetic container ■ Durable
■ Sterile ○ Disadvantage:
■ Impervious to air ■ Permeability is higher than
■ Vials glass, prone to leaching
○ Light-resistant container ○ Thermosets
● Quantity held ■ Rigid, non-meltable, melts
○ Single unit down powder
■ One dose ○ Thermoplastics
○ Multiple unit ■ Flexible, polymer material,
■ Multiple dose liquifies when heated
● Metal
MATERIALS USED IN PACKAGING ● Rubber
● Paper and board
● Glass
○ Advantages: SUMMARY INFORMATION IN LABELS
■ Good barrier properties
■ Inert ● Name of preparation
■ Transparency ● Quantity
■ Sparkle ● Instructions for the patient
■ Easy cleaning ● Patient’s name
■ Effective closuring and ● Date of dispensing
reclosuring ● Name and address of pharmacy
■ Good rigidity and ● “Keep out of reach of children”
stackability (for storage) ● Warning, batch number, expiry date,
○ Disadvantages additional legal req.
■ Fragile
■ Heavy STORAGE OF PHARMACEUTICAL
○ Types:
■ Type I ● Cold
● Highly resistant ○ Not exceeding 8℃
borosilicate glass ○ Refrigerator: 2℃ to 8℃
● For buffered and ○ Freezer: -25℃ to -10℃
non-buffered aq ● Cool
soln. ○ 8℃ to 15℃
■ Type II ● Room Temperature
 ○ Temperature prevailing in work
area
● Controlled Room Temperature
○ 20℃ to 25℃
○ Allow temperature variations
between 15℃ to 30℃
● Warm
○ 30℃ to 40℃
● Excessive Heat
○ Above 40℃
● Protection from Freezing
○ Indicated when addition to the risk
of breakage of container, loss of
potency, etc.
● No specific storage or limitations
○ Protection from moisture, freezing
and excessive heat
COMPOUNDING
● The preparation, mixing, assembling,
packaging or labelling of products
● Includes preparation of drug devices in
anticipation of prescription
● Extemporaneous compounding
● Practitioner-patient-pharmacist
relationships
● Not manufacturing - not in a commercial
scale
○ Compounding - small scale ;
manufacturing - large scale
CURRENT GOOD COMPOUNDING PRACTICES
● Compounding environment
○ Design and maintenance facilities
○ Compounding equipment is
appropriate design and size
suitable for intended use
● Stability of compounded preparations
○ Packaging, sterility criteria,
guidelines for assigning
beyond-use dates
● Ingredients selection calculation
○ USP or NF Grade
○ Drug of the highest quality and
available
○ ACS or FCC Grade
○ Material Safety Data Sheets
○ Manufacture drug product as a
source of drug
● Checklist for acceptable strength, quality,
and consistency*
● Compounded Dosage Forms
○ Quality control characteristics
○ Compounding process
○ Steps involved in the compounding
(template)
● Compounding records and documents
○ Formulation record
○ Compounding record
■ Important dates
■ If you conformed to the
process
● Quality Control
○ Tests to determine quality control
characteristics
○ Reviewing procedures
● Patient Counselling
○ Advising proper use and storage
INTERNATIONAL CLIMACTIC ZONES
● Zone I: Temperate
● Zone II: Subtropical, with possible high
humidity
● Zone III: Hot/Dry
● Zone IV: Hot/Humid (Philippines)