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Solid Dosage Forms

Active pharmaceutical ingredients are combined with pharmaceutical excipients and processed into solid dosage forms or drug products for administration. Solid dosage forms include tablets, capsules, and powders, which have advantages for both manufacturers and patients. Tablets are the most common solid dosage form and can be produced through compression or molding. They contain one or more active ingredients mixed with excipients. Capsules contain medications in either a hard or soft gelatin shell. Proper formulation and processing of active ingredients and excipients into standardized solid dosage forms provides accurate, convenient, and stable drug delivery.

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351 views4 pages

Solid Dosage Forms

Active pharmaceutical ingredients are combined with pharmaceutical excipients and processed into solid dosage forms or drug products for administration. Solid dosage forms include tablets, capsules, and powders, which have advantages for both manufacturers and patients. Tablets are the most common solid dosage form and can be produced through compression or molding. They contain one or more active ingredients mixed with excipients. Capsules contain medications in either a hard or soft gelatin shell. Proper formulation and processing of active ingredients and excipients into standardized solid dosage forms provides accurate, convenient, and stable drug delivery.

Uploaded by

cofodike1
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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API + Pharmaceutical Excipients = Dosage forms

Active pharmaceutical ingredient (API): is the active ingredient in a


pharmaceutical drug or a pesticide that is biologically active.
Pharmaceutical Excipients: nondrug components
Dosage forms: drug products in the form in which they are marketed for
use.
Drugs are prepared in various dosage forms for administration.
Advantages of Dosage forms- Manufacturer
Simplicity
Economy of preparation
Stability
Convenience in packaging, shipping and dispensing
Advantages of Dosage forms - Patient
Accuracy of dosage
Compactness
Portability
Blandness of taste
Ease of administration.
Pharmaceutical dosage form:
drug delivery system which is formed by technological processing of
API(s), typically in association with one or more other ingredients,
determines the physical form of the final pharmaceutical preparation.
o Must reflect therapeutic intentions, route of administration,
dosing etc.
solid oral dosage forms include tablets, capsules, caplets,
encapsulated beads, and gelcaps.
Solid dosage processing
The solid type of preparation is most common.
Dosage forms:
o (aka unit doses) are essentially pharmaceutical drug products in
the form in which they are marketed for use, typically involving a
mixture of active drug components and nondrug components
(excipients), along with other non-reusable material that may
not be considered either ingredient or packaging e.g. capsules.

Quality factors: Must reflect


administration, dosing etc

therapeutic

intentions,

route

of

Pharmaceutical Excipients:

A pharmacologically inert, adhesive substance, as honey, or syrup


used to bind the contents of a pill or tablet.
o nondrug components
o
Any substance other that the active ingredient or pro-drug that has
been appropriately evaluated for safety and is included in a drug
delivery system to:
o Aid processing during manufacturing
o Protect, support, or enhance stability, bioavailability, or patient
acceptability
o Assist in product identification or
o Enhance any other attribute of the overall safety and
effectiveness of the drug product during storage or use

Particle properties:
The particle size distribution (PSD) of the drug substance may have
significant effects on final drug product performance such as the drugs;
dissolution, bioavailability, content uniformity, stability, etc.
Particle properties of both drug substance and excipients can
affect drugs product manufacturability flowability, blend uniformity,
compactibility, which, can ultimately impact safety, efficacy, and
quality of the drug product.
Processing routes:
Solid dosage processing equipments for the pharmaceutical
industry, include: fluid bed dryers/granulators, Wurster coaters,
high-shear granulators, size reduction systems and process
control software for batch-type equipments
Unit operations
Size reduction (milling)
Blending
Dry granulation (roll compaction)
Wet granulation
Drying
Tablet compaction
Coating
Solid dosage forms

Oral
Tablets:
o Is solid pharmaceutical dosage forms containing drug substances
with or without suitable diluents and prepared either by
compression or molding methods.
Dissolution is the rate-limiting step in the delivery of drug
from a tablet to the systemic circulation.
o Tablets may differ greatly in size and weight depending on the
amount of drug substance present and the intended method of
administration.
o They are divided into two general classes, whether they are
made by compression or molding.
o Compressed Tablets (CT): Are formed by compression and
contain no special coating.
They are made from powdered, crystalline or granular
materials, alone or in combination with binders,
disintegrates, controlled-release polymers, lubricants,
diluents and, in many cases, colorants
o Molded Tablets (AKA tablet tribulates):
Tablet triturates usually are made from moist material
using a triturate mold which gives them the shape of cut
sections of a cylinder. Such tablets must be completely and
rapidly soluble.
Lozenges: contain a drug substance in flavored base.
Chewable tablets: are placed in the mouth, chewed and swallowed.
Effervescent tablets: contain sodium bicarbonate in addition to the
drug substance.
Multi-layer tablets:
o Multiple compressed tablets: These are compressed tablets
made by more than one compression cycle.
o Layered Tablets - Such tablets are prepared by compressing
additional tablet granulation on a previously compressed
granulation. The operation may be repeated to produce
multilayered tablets of two or three layers. Special tablet presses
are required to make layered tablets

Modified release: a more advanced version in which release of the


active ingredient is related to time.
Capsules:
o The drug is contained in a gelatin shell that breaks open after the
capsule has been swallowed, releasing the drug.
Hard gelatin: contain solid drugs
Soft gelatin: contain oils
o 60% of drugs are manufactured as capsules.
Powders:

The

o Drugs or drug extracts that are dried and ground and micronized
into fine particles.
Inhaled:
Aerosol
o a substance enclosed under pressure and able to be released as
a fine spray, typically by means of a propellant gas.
Metered dose inhalers: an apparatus for administering
vapor or volatilized medications by inhalation
Dry powder inhalers: is a device that delivers medication
to the lungs in the form of a dry powder.
advantages of solid drug forms are
Convenience of administration;
Accuracy and reproducibility of a dosing;
Increased of a drug stability and easy of mass production.

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