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PHARMACEUTICAL
TECNOLOGY
(ESSENTIALS)
Part 1
Yauheni Hryniuk,
Associate professor
History
tablets
capsules
sugar-coated tablets (dragee)
powders
granules
sachets
Powders
latin - pulvis (pulv.)
Powders are drugs or drug extracts that are
dried and ground and micronized into fine
particles.
According to the division into prescribed doses
powders are pulveres indivisi (all doses are given
inseparably) and pulveres divisi (they are divides
into the prescribed number of doses).
According to the composition are simplex
powders (consist one active ingredient) and
complex powders (a mixture of more than one
active ingredient).
Solid dosage forms
Тablets
A tablet is a solid dosage form that is
prepared by compressing or molding of
the drug into various sizes and shapes.
Dissolution is the rate-limiting step in
the delivery of drug from a tablet to the
systemic circulation.
Advantages
Production aspect
Large scale production at
lowest cost
Easiest and cheapest to
package and ship
High stability
User aspect (doctor, pharmacist,
patient)
Easy to handling
Lightest and most compact
Greatest dose precision &
least content variability
Disadvantages
Some drugs resist compression
into dense compacts
Drugs with poor wetting, slow
dissolution, intermediate to
large dosages may be difficult or
impossible to formulate and
manufacture as a tablet that
provide adequate or full drug
bioavailability
Bitter taste drugs, drugs with an
objectionable odor, or sensitive
to oxygen or moisture may
require encapsulation or
entrapment prior to
compression or the tablets may
require coating
Types of tablets:
wet granulation: suitable for drugs that are stable to moisture and
granulation heat
dry granulation: suitable for drugs that are sensitive to moisture
and heat
powder compression : suitable for drugs that are sensitive to
moisture and heat, fill material possessing, good flowability and
direct compressibility
compression
crystal compression:suitable for drugs with proper
crystal form and good flowability
The classification of tablet presses
Tablet presses:
a. single-punch presses
Core components:
die
lower punch
upper punch
Tablet coating
The reasons for tablet coating
1) to protect the medicinal agent against
destructive exposure to air and/or humidity;
2) to mask the taste of the drug;
3) to provide special characteristics of drug
release;
4) to provide aesthetics or distinction to the
product;
5) to prevent inadvertent contact by
nonpatients with the drug substance
Tablet coating
Friability
1) It is used to determine a tablet’s durability
2) Method: allowing the tablets to roll and
fall within the rotating apparatus
(friabilator); determine the loss in weight;
3) requirement: weight loss ≤1%
Quality standards and compendial
requirements — tablet dissolution
1) The importance of in vitro dissolution test
a) to guide the formulation and product
development process toward product optimization
b) to monitor the performance of manufacturing
process
c) to assure bioequivalence from batch to batch
d) as a requirement for regulatory approval for
product marketing for products registered with the
FDA and regulatory agencies of other countries.
2) The goal of in vitro dissolution is to provide a
reasonable prediction of the product’s in vivo
bioavailability.