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prescription order
specific for a
particular patient
Any organization or company involved in the
manufacture, importation, repacking and/or
distributions of drugs or medicines
any establishment engaged in operations
involved in the production of drugs
A056 s 1989
IRR of RA 9711
a. Ethical Manufacturers
◦ prescription drugs
c. Biologicals Manufacturers
◦ vaccines, toxoids, antisera, biotech products
d. Veterinary Products Manufacturers
◦ animal drugs
IRR 9711
registered owner of the drug product but
subcontracts toll manufacture of such
products to a licensed manufacturer
AO56
RA 9711
Procures raw materials , active ingredients
and or finished product from local
establishment or for local distribution on
wholesale basis
RA 9711
develops new or existing products
3 facilities:
◦ a. library
◦ b. animal house
◦ c. pilot plant
manufacturing of drug products
“heart & soul” of a drug manufacturer
sampling, testing, assaying of drugs
promotes
maximum volume
of sales of products
locates, installs, repairs and maintains
equipment
ensure plant and personnel safety
purchases, receives and inventories supplies
physical and medical
examination of
employees and
applicants
clinical studies
prepares product
inserts and literature
publishes company’s
newsletter / organ
Current Good Manufacturing Practices
- WHO 2007
System of quality assurance aimed at
ensuring that products are consistently
manufactured to a quality appropriate for
intended use and is concerned with
manufacturing and quality control process
and procedures
AO43 s 1999
Part of quality assurance which ensures that
medicinal products are consistently produced
and controlled to the quality standards
appropriate to their intended use.
AO43 1999- adoption of the 1st edition of the
current GMP guidelines by FDA
generally sterile
protects the
contents from
photochemical
deterioration
amber, opaque,
blue
designed to hold a
quantity of drug
intended for
administration as a
single dose
sterility is not
assured after
opening
ex. vial
Type General Description Uses Test
• low-density (LDPE)
droppers & sprays
• high-density
(HDPE)
solid oral prepns
Polyethylene Terephthalate
(PET)
• for beverages
• APETG (amorphous PET
glycol)
• PETG (PET glycol)
• have transparency and luster
• gamma radiation sterilization
Polypropylene (PP)
• autoclavable
Polyvinyl Chloride
• rigid & good clarity
• blister packaging
aluminum, tin &
steel
aka: - chartula
drug used: non-potent potent
preparation: block & divide geometric dilution,
preferably weighing
2. compressibility
1. alteration of particle size and size
distribution
◦ use larger particles
◦ reduce the amount of fines
2. alteration of particle shape or texture
◦ the more spherical and smoother the particles,
the more flowable
rendered plastic-
like with the
addition of
plasticizers
(glycerin or
sorbitol)
oblong, oval, spherical, tube, pearl,
suppository-type
methods:
◦ plate process
◦ rotary or reciprocating die process
partial hydrolysis of
collagen from
animals
HGC= 200-250g
SGC= 150g
a solid dosage form
which may or may
not contain
medicinal
substances with or
without diluents
and prepared either
by molding or
compression
most widely-used
dosage form
Single punch/eccentric press- 200 tablet per
minute
Superdisintegrants
croscarmellose
crospovidone
sodium starch
glycolate (Explotab®)
improve the flow properties of granules by
reducing the friction among particles
can be
◦ natural
◦ synthetic
FD&C – food, drug & cosmetics
D&C – drug & cosmetics
external D&C – external use only
Dyes – water soluble
Lakes – water insoluble
oils or dry powders are used in formulations
stevia (Stevia
rebaudiana)
saccharin – has bitter aftertaste
*contraindicated to phenylketonurics
successive addition of sucrose-based
solutions to a tablet core
1. Pan Coating – most widely-used
2. Pan Spraying
3. Pan Suspension
1. Sealing / Waterproofing
2. Subcoating
3. Syruping / Smoothing
4. Finishing
5. Polishing
to protect the tablet core from water in
subsequent steps
substeps:
a. Grossing – for color base
b. Heavy Syruping
c. Regular Syruping
employs “jogging” (quick on-off)
to attain final smoothness
for sheen or gloss
ex. beeswax, carnauba wax
the process of placing a thin, skin-tight
coating of a plastic-like material over a tablet
core
1.functional
2. non-functional coat
produces smooth, thin film
examples:
◦ cellulose acetate phthalate
◦ hydroxypropyl methylcellulose (HPMC)
provides water-solubility / permeability
ex. beeswax
vehicle that evaporates rapidly used for
spreading the components
ex. alcohol-acetone mixture
designed to resist dissolution in the stomach
but dissolve in the less acidic environment of
the small intestines (pH 4.8 or greater)
Mixers
Propeller
Turbine
Inline
Clarification system
consider solubility & stability
consider clarity, toxicity, viscosity,
compatibility, palatability
examples:
◦ ethanol
◦ sorbitol
◦ glycerin
◦ propylene glycol
◦ polyethylene glycol
surfactants (Tweens)
improves pourability and to some extent,
palatability
filter media:
◦ cellulose nitrate
◦ polyamide
◦ polyvinylidene chloride
◦ nylon
Gravity filtration
◦ slow
Vacuum filtration
◦ very large quantities
Pressure filtration
◦ fast, to achieve highly polished product
Parallel filtration
◦ one type of filter
Series filtration
◦ more than one filter
Perforated basket centrifuge- crystalline
materials
Vacuum filling
◦ for viscous solutions
Pressure filling
◦ for viscous solutions
liquid dosage forms containing finely divided
drug particles distributed somewhat
uniformly throughout a vehicle in which the
drug exhibits a minimum degree of solubility
flocullated Deffloculated
definition Loose aggregates of Particles are
particles (granule separate entities
like) (powder like)
Sedimentation rate faster slower
Clays
◦ bentonite, kaolin
others:
◦ agar, gelatin, pectin, gelatinized starch
Buffer
Sweetening agent
Flavoring agent
Colorant
Preservative
1. Caking
2. Partial solubility of the active ingredient
3. Polymorphism of the active ingredient
are dispersed systems in which the dispersed
phase is composed of small globules of a
liquid distributed throughout a vehicle in
which it is immiscible
acts as the bridge between the 2 immiscible
phases
stabilizer of the internal phase
retards coalescence of the globules
Natural
◦ gelatin, egg yolk, acacia, tragacanth, cellulose
derivatives
Synthetic
◦ Tweens, Spans, SLS, SLES
protects the emulsified lipids which are
susceptible to oxidation
Differing cleanliness
5 sections
◦ Materials support area
◦ Compounding area
◦ Aseptic filling area
◦ Quarantine area
◦ Finishing area
Carrying out less critical stages of the
manufacture of sterile
surfaces should be continuous
class 10,000 environment
99.95% efficiency
Used to test efficiency of heap filter:
◦ DOP (dioctylphtalate test)
storage while waiting for QC results
a. Active drug
b. Solvent / Vehicle
◦ aqueous
water for injection
◦ water miscible
glycerin
ethanol
propylene glycol
PEG 400 & 600
◦ vegetable oils
corn oil
peanut oil
sesame oil
cottonseed oil
◦ non-vegetable oils
benzyl benzoate
ethyl oleate
isopropyl myristate
c. Other Excipients
◦ buffer
citrates
acetates
phosphates
◦ preservative
chlorobutanol
benzyl alcohol
parabens
◦ chelating agent
EDTA
◦ glass, plastic
Dry Heat
◦ oven (160-170ºC, 2-4 hrs)
◦ 6500C in 1 minute, 2500C in 45 minutes, and 1800C
in 4 hours
Gas
◦ ethylene oxide
Ionizing Radiation
Bacterial Filtration
◦ membrane filters
Tyndallization
◦ intermittent steam sterilization exposing material
to 100ºC for 30 min or at 80ºC for 1 hr for 3
consecutive days
environment:
◦ blood agar plate
◦ RODAC contact plates (Replicate Organism
Detection and Counting)
2. pull seal
More efficient