Uy, Alyssa V.

2BPh

Effervescent Tablets prepared by compressing granular

effervescent salts that release gas when in contact with water.
This tablet contains medicinal substance which dissolves rapidly
when in contact with water.

Molded Tablet Triturate (M.T.T.) small & cylindrical, very soft,

soluble & designed to dissolve rapidly.

Compressed Tablet Triturate (CTT) prepared by compression

(limited pressure) usually containing potent substance. Sucrose
and lactose are used for diluent.

Hypodermal Tablet (H.T.) used by physicians for

extemporaneous preparations of parenterals. It is meant to be
dissolved in suitable vehicle, sterility attained, and the injection
performed. The advent of prefabricated injectable products and
disposable syringes declined its use.

Dispensing Tablets (D.T.) or compounding tablets used by

pharmacists when compounding prescriptions and not dispensed
to patients. It contains large amount of potent subs. enabling the
pharmacist to obtain pre-measured amounts. For compounding
multiple dosage units.

Immediate Release Tablets (I.R.) designed to disintegrate and

release their medication and therefore are devoid of special rate
controlling features like coating and other ways.

Instant Disintegrating/Dissolving Tablets characterized to

dissolve within 10 seconds to 1 minute. This is possible with the
use of lyophilization techniques, soft direct compression, or the
use of water-soluble excipients designed to wick water into the
tablet for rapid disintegration.

Extended Release Tablet (E.R.) /Controlled Release (C.R.)

designed to release their medication in a predetermined manner
over an extended period of time.

Vaginal Tablet/Inserts uncoated and bullet- or ovoid- shaped

tablets for localized effect. Prepared by compression and shaped
to fit smugly into plastic inserter devices. They contain
antibacterials (against Hemophilia vaginitis) and antifungals
(against Candida albicans)

CHAPTER 8 Tablets
Tablets - solid dosage forms usually prepared with the aid of suitable
pharmaceutical excipients
Majority are administered orally, while others sublingually, buccally or
vaginally contain features most applicable to their routes of administration.
Types of Tablets:

Compressed Tablets (C.T.) - manufactured with tablet machine

capable of exerting great pressure or compacting the powdered
or granulated tableting material. DILUENTS, BINDERS, DISINTEGRANTS,
ANTIADHERENTS/ GLIDANTS/LUBRICANT, COLORANTS/FLAVORANTS

Multiple Compressed Tablets (MCT) prepared by subjecting the

fill material to more than a single compression, the core (inner)
and shell (outer)
Sugar-Coated Tablet (S.C.T.) the coating maybe colored or
uncolored sugar layer, water soluble and quickly dissolved after
swallowing. Purposes: to protect the enclosed drug from the
environment and to provide a barrier to objectionable taste and
smell of the drug. Disadvantages: time and expertise needed in
the coating process and increased shipping costs
Film-Coated Tablets (F.C.T.) coating is made of thin layer of a
polymer capable of forming a skin-like usually colored film over
the tablet. Polymer is cellulose acetate phthalate. Advantages of
film coating over sugar coating: more durable, less bulky and less
time consuming to apply.
Gelatin Coated Tablet capsule-shaped compressed tablet with
1/3 the size of capsule with the same amount of fill, more ease in
swallowing & more tamper evident. (GelCaps)
Enteric-Coated Tablets (E.C.T.) have delayed release features,
designed to pass the stomach to the intestines where the tablet
will disintegrate allowing drug dissolution & absorption. Needed
when drug substance:
a)
b)
c)

is destroyed by gastric acid

is irritating to the gastric mucosa
by-passed the stomach enhances the drug
absorption in the intestines

Buccal tablets flat, oval tablets intended to be dissolved slowly

in the buccal pouch. It is for oral absorption of drugs destroyed by
gastric acid or poorly absorbed in the GI tract.

Sublingual Tablets designed to erode promptly underneath the

tongue for rapid drug effect.

Lozenges or troches disc-shaped solid forms containing a

medicinal substance in a hard candy or sugar base. Meant to
dissolve slowly for localized effect or systemic effect

Chewable Tablets have rapid disintegration when chewed or

allowed to dissolve in the mouth, have a creamy base usually
specially flavored and colored mannitol. Meant for large-sized
tablets given to children and adults with difficulty in swallowing
solid dosage forms

The physical features of compressed tablets are varied; its

diameter and shapes are determined by the die and punches used
in the compression. The less concave the punch, the more flat the
resulting tablets. Punches with raised impressions will have
recessed impressions on the tablets.
Quality Standards and Compedial Requirements:

USP Weight Variation Test: 10 tablets are individually weighed

and average weight calculated.

Content Uniformity: Dosage units are assayed individually and

requires that each dosage unit is 85% - 115% of the label claim
(S.D. is less than 6%)

Tablet thickness is determined by

a.
b.
c.
d.

the diameter of the die

the amount of fill
the compactibility of the fill material
the force of pressure applied during compression.

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Tablet thickness is measured by a hand gauge.

Tablet hardness affects its disintegration & drug absorption. The

greater the pressure, the harder the tablet. It should be hard
enough to resist breaking during the normal handling and yet soft
enough to disintegrate properly after swallowing.

A force of 4 kilograms as determined by hardness tester is

minimum requirement for a satisfactory tablet.

Tablet friability the tendency to crumble by allowing it to roll

and fall within the rotating machine (friabilator). A maximum
weight loss of not more than 1% of the weight of the tablets being
tested is acceptable.

Tablet Disintegration Test uses a basket-rack assembly

containing 6 open ended transparent tubes held vertically upon a
10-mesh stainless steel wire screen.
The basket is raised and lowered in the immersion fluid (water at
37oC) at a frequency of 29-32 times per minute. Result: the
residue of the tablet on the screen is a soft mass having no
palpable inner core. Disintegration time ranged from 2 mins. to 4
hours depending upon the monograph.
For enteric coated tablets, test is done in a simulated gastric fluid
for 1 hr. No sign of disintegration must be seen. They are
immersed in a simulated intestinal fluid for the time stated in the
monograph where they disintegrate completely.

are withdrawn for chemical analysis. Samples must meet the requirement
stated in the monograph.
Pooled dissolution testing samples coming from different batches placed
in individual dissolution vessel in the apparatus or multiple dosage units in a
single vessel. This recognizes the concept of batch characteristics.

3 methods for compressed tablet:

Wet Granulation: Weighing and blending of ingredients (A.I. &
adjuvants) + liquid binder screen the damp mass (Sieve 6-8)
dry size the granules (Sieve 12-20) + lubricant and blend
compress

Fillers lactose and microcrystalline cellulose

Binder to facilitate adhesion of powder particles.

Starch, povidone, methylcellulose.

Flavorant and colorant are added to binder.

Lubricant to improve the flow of granules from the

hopper to the die; prevent adhesion to the punches
and die during compression; reduce friction between
tablet and dies wall during tablet ejection and provide
tablet sheen. Calcium and magnesium stearate are
examples.
All-In-One Methods:
1) Fluid-bed Process fluid-bed granulator
which performs the blending, granulating,
drying into 1 continuous process
2) Microwave Vacuum Process powder mix
is mixed, wetted, agglomerated and dried
using microwave

Tablet dissolution test - Uses:

a.
b.

guides formulation and product development

performance of manufacturing process can be
monitored by it (quality assurance)
c.
Consistent results assure bioequivalence from batch
to batch
d. As a requirement for regulatory approval
Its goal to provide a reasonable prediction or correlation with
the products in vivo bioavailability.
a)
b)
c)
d)

High Solubility and High Permeability IVIVC

Low Solubility and High Permeability IVIVC
High Solubility and Low Permeability limited IVIVC
Low Solubility and Low Permeability none

In (a) IVIVC is expected if the dissolution time is slower then

gastric emptying time (limiting factor).

Dissolution Test Apparatus consists of:

1.
2.
3.

4.

variable stirrer motor

stainless basket on a stirrer shaft (Apparatus I) or a
paddle as stirrer (Apparatus II)
1-L vessel glass with a cover having the shaft of the
stirrer fitted at the center port, with 3 ports for
samples and 1 port for the thermometer
Water bath to maintain the temp. of the medium in
the vessel

Dissolution medium is placed in the vessel at 37oC + 0.5o C. The stirrer is

rotated at speed specified and at stated intervals; samples of the medium

Dry Granulation the powder mixture is compacted to large

pieces and broken down or sized into granules

Active ingredient or diluent must have cohesive

properties.

Advantages: For materials that are degraded by

moisture or by elevated temperature during drying

Steps in Dry Granulation: Weighing & blending powder

mix slugging sizing + lubricant compression

Tableting machine compress tablet formulation

within a steel die cavity by the pressure exerted by the
movement of the two steel punches (upper and
lower).

Imperfections of tablets:
a) a)Laminations horizontal striations
b) Tablet capping the top of tablet
separates from the whole
c)
Tablet splitting

Reasons:
a) particles has no time to bond due to
fast high speed production
b) air is entrapped during direct
compression
c)
punches not clean
d) aging

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Direct Compression appropriate for chemicals with flowing and

cohesive properties

Tablet Deduster to remove traces of loose powder

adhering to the tablets following compression.

Tablets are coated:

b)
c)

1) to protect from air and/or humidity

2) mask the taste
3) provide characteristics of drug release
4) to provide aesthetics or distinction to the product
Sugarcoating tedious, time-consuming and needs
expertise of qualified technician and the product
doubles the size and wt.

Film coating provides a thin, skin-tight coating of a

plastic material over the compressed tablet.

Components:
a) Film former to produce thin smooth film. Cellulose
acetate phthalate
b) Alloying substance to provide water solubility/
permeability for body fluids to penetrate through and
make the drug available. Polyethylene glycol
c) Plasticizer to produce elasticity/flexibility to the
coating & provide durability. Castor oil

Advantages: Size and wt. almost the same as the

tablet, more resistant to destruction by abrasion,
markings can be embossed on the coating.

Enteric coating maybe accomplished through coating

with enough thickness or coating which allow
dissolution at a pH 4.9 or higher. Example is shellac

Fluid Bed or Air Suspension Coating spray coating of

powder, pellets, granules or tablets held in suspension
by a column of air

Depending where the coating solution come from:

more uniform coating

uses less coating material resulting to
lighter, smaller and easy to swallow
tablets
d) less expensive to package and ship
Packaging and Storage:
a) Use tight, light resistant (amber) containers,
if adversely affected by light
b) Store in places of low humidity and protected
from extreme temperature
c) Use desiccant pellet is affected by moisture

Oral administration of solid dosage forms

Lozenges by compression or molding. Meant to dissolve slowly in the
mouth for localized effect.
Impact of Changes on Solid dosage forms:
1. Changes in formulation
a) active ingredients
b) excipients
c) their quantities
d) addition of new excipients
2.

Changes in methods of manufacturing

a) new machineries
b) different steps in manufacturing
c) different in process controls, tests or assay methods
d) production of different batch sizes
e) use of different product reprocessing procedures
f) suse of different manufacturing sites

a) Wurster the bottom of the cylinder

b) Top spray sprayed downward
c) Tangential spray techniques rotary fluid
bed coater

Top spray recommended for taste masking, enteric

release and barrier film on tablets.
Bottom spray for sustained release and enteric
release
Tangential layering coating, sustained and enteric
releases
Compression Coating the coating material
(granulation or powder form) is compressed into the
tablet core.
Advantages:
a)

It is anhydrous process appropriate for

drugs affected by moisture

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