Tablets

Dispensing II
Myron Urbina, Ariadna Gutierrez and Jasqueena De La Fuente
Objectives

● Types of tablets
● Specifications of tablets (Evaluation of tablets)
● Dispensing of tablets
● Containers, labeling and storage for tablets
● Observable signs of instability
● Counseling for use of tablets
Types of Tablets

● Compressed - made by compressing powdered materials into a desired shape/size.

● Multiple compressed - (layered tablets) achieved by subjecting powdered materials to
more than a single compression.
● Uncoated - generally single-layer compressed tablets with no signs of coating.
● Sugar coated - sugar coating providing color, protection of enclosed materials and
masking of taste/smell of materials.
● Enteric coated - specifically for the purpose of delaying the release of its active drug.
● Film coated - compressed tablets coated with a thin layer of a polymer.
● Gelatin coated - capsule shaped compressed tablets coated with gelatin.
● Chewable - designed to be chewed or dissolved in the mouth before swallowing .
● Effervescent - compressed granulations containing sodium bicarbonate and organic acids that
react in the presence of water.
● Inlay - a form of a compressed tablet in which their is partial coating, leaving on side of the
tablet exposed.
● Extended Release - designed to release their medication over a predetermined or prolonged
manner.
● Buccal or Sublingual - small, flat or oval shaped that tend to dissolve within the buccal pouch or
beneath the tongue for rapid absorption through the oral mucosa.
● Implants - long acting sterile tablets that are designed to release a drug over a period of months
or a year.
● Vaginal - compressed uncoated bullet or oval shaped tablets made for the purpose of vaginal
administration.

Chewable Tablet Effervescent Sublingual

Specifications and
Evaluation of Tablets

Specifications for Tablets:

● ensure that the active ingredient(s) have appropriate solid-state properties such as particle size
distribution and polymorphic form
● ensure that mixing with excipients is carried out in a manner that ensures homogeneity
● ensure that the tablets possess a suitable mechanical strength to avoid crumbling or breaking on
subsequent processing, e.g. coating, storage and distribution
● minimize the degradation of the active ingredient(s)
● minimize the risk of microbial contamination
● minimize the risk of cross-contamination
Evaluation of Tablets:

● Visual inspection (appearance - shape/size)

● Hardness
● Friability
● Uniformity of mass
● Uniformity of content
● Disintegration
● Dissolution
Procedure for Manufacturing of Tablets
Dispensing: Each Dispensing: Each ingredient in the tablet
formula is weighed and accurately dispensed as per dose. This
is one of the critical steps in any type of formulation process
and should be done under technical supervision.

Sizing: Formulation ingredients must be in finely divided

form, otherwise, size reduction should be carried out for better
flow property and easy mixing.

Mixing equipment e.g., pneumatic mixers diffusion/ tumbling

mixers (e.g., V- blender, double cone blender, cubic mixer,
drum blender)
Granulators e.g. , Rotating shape granulators , dry granulator , high shear granulator etc

Drying equipment e.g. spray dryer , rotary dryer , fluidized bed dryer etc

Tableting machine e.g. single punch tablet press and multi station /rotary tablet press Exp. Fette Press, CardPress
etc

Dry Granulator Spray Dryer Single Punch Tablet Press

Evaluation /Quality control (QC) equipment
e.g., disintegration equipment , USP Dissolution Tester, Tablet Hardness Tester, Tablet Thickness Tester,
Tablet Friability Testers etc.

Coating and polishing machines for coated tablets

e.g., standard coating pan, perforated pan, fluidized bed/ Air suspension coating system etc.

Packaging machines e.g., blister packing machine, aluminium foil packaging machine, etc.

Disintegration Equipment Coating Machine

Blister Packaging Machine
 Tablet Manufacturing Equipment/ Machines
Common equipment used in pharmaceutical tablet manufacturing include:

Size reduction equipment e.g., Hammer mill , roller mill , fluidized energy mill , cutter mill and ball mill.

Weighing balance/ balances e.g., bulk weighing balance (weighs in kilogram), electronic weighing balance
(weighs in grams and milligrams).

Hammer Mill Machine Weighing Balances

Blending: Powders blender to obtain are mixed using a a uniform and homogeneous
powder mix. The drug substance and excipients are mixed in geometric dilution.

Granulation: Here small powder particles are gathered together into layers, and
permanent aggregates to render them into free-flowing states.

Drying and dry screening: Screened wet granules need to be dried for a particular
time period in tray dryer or fluid bed dryer at controlled temperature not exceeding
550 degree Celsius . Dried granules are screened through the appropriate mesh
screen
Tablet compression: This step involves the compression of granules into a flat or
convex, round, oblong, or unique shaped, scored or unscored tablets; engraved
with an identifying symbol and/ or code number using tablet press.

Coating: Tablets and granules are coated if there is need to mask the unpleasant
taste/odour of some drug substance or to increase the aesthetic appeal of
uncoated tablets as well as to modify the release or control the release of drug
substance from tablets. This is achieved by enclosing or covering the core tablet
or granules with coating solutions.
Methods used in tablet Formulation
Tablets are commonly manufactured by:
1. Wet granulation
2. Dry granulation
3. Direct compression
 WET
GRANULATION
Wet granulation is a widely used method for the production of compressed
tablet. It is essentially a process of size enlargement involving several steps and
the use of an adhesive substance known as binder.

The granules produced using this method of meeting all granulation has a
greater probability of the physical requirements for tablet formation.
 Methods:
1.Weighing, milling and mixing of the APIs with powdered excipients(excluding the
lubricant) 2. Preparation of binder solution 3.Mixing of binder solution with powders
to form a damp mass 4.Screening the dampened powder into pellets or granules (wet
screening) using 6- to 12-mesh screen
5. Drying of moist granules
6.Sizing the granulation by dry screening using 14- to 20-mesh screen
7.Mixing of the dried granules with lubricant and disintegrates
8. Compression of granules into tablets
DRY GRANULATION
The formation of granules by compacting powder mixtures into large pieces or
compacts which are subsequently broken down or sized into granules (often
referred to as dry granulation, double compression or precompression) is a
possible granulation method which, however, is not widely used in the
manufacture of tablets.
Dry granulation method
• Weighing and Milling of formulation ingredients
(drug substance and excipients)
• Mixing of milled powders.
• Compression of mixed powders into slugs.
• Milling and sieving of slugs.
• Mixing with disintegrate and lubricant.
• Compression into tablet.
 DIRECT COMPRESSION

● Direct compression involves direct compression of

powdered materials into tablets without modifying the
physical nature of the materials itself.
● Direct compression problems associated avoids with many
of the wet and dry granulations.
Compression

● Tablets are being formed by compressing the granules by using the

compression machine.
● Tablet formed in compression machine by pressing the granules in
die with lower and upper punch. Tablet formation takes place by the
combined pressing action of two punches (lower and upper) and a
die.
● Now it is possible to produce more than 500,000 tablets per hour due
to different’s innovations to tablet compression machines.
Containers, Labelling and
storage for tablets

Packaging Definition: Packaging is the science, art and technology of enclosing, protecting a
product and providing information about the product for distribution, storage, sale and use.

Role of packaging:

● Protection
● Identification
● Information transmission
● Storage
● Convenience
Types of Packaging for tablets

1. Blister package

2. Strip package

3. Alu-alu packaging

4. Bottle packaging
Materials Critical properties Area of use

HDPE (High-density Good barrier for moisture, All kind of products from
polyethylene)Container gas and light solid orals and dry syrup

PET/PP (amber) Moderate barrier to Light sensitive products

moisture and gas
 Blister Package

● Blister packs are commonly used for unit dose packaging for
tablets and capsules.

● The principal components of a blister pack comprise of

1. Forming film (blister): A pocket inside which the product fits

2. Backing : The lidding foil sticked over the back of a blister.

Strip packaging

Strip Package: A strip package is formed by feeding two

webs of a heat sealable flexible film through a heated
crimping rollers. This package is used for both capsules
and tablets.

Materials used:

● Foil laminations (for moisture sensitive products)

● Paper
● Polyethylene
● Cellophane (Transparent plastic film formed from processed
cellulose)
Alu-alu packaging
Alu-alu packaging Alu-alu packing means aluminium foil at both the upper and lower
side of pack. Alu- alu packaging is similar to that of blister packing the only
difference is that the forming film is formed of aluminium foil instead of plastic
material.
Bottle Packaging
Bottles are commonly used for liquid pharmaceuticals as well as for tablets and capsules.

Materials used:
Bottle:
● Polyethylene
● Polypropylene screw cap
● Polystyrene

Bottle mouth seal: Aluminium foil

Requirement of a label
1. The name of preparation

2. Strength and dosage form.

3. Quantity.

4. Instructions for the use.

5. Precautions & warnings.

6.Registration number.

7. Batch number.

8. Manufacturing & Expiry date .

9.Price

10.The name and address of pharmaceutical industry

 UB Medical Center
Address: 22 Dunn Street. Orange Walk Town
Phone Number: 631-6622

Name: Nestor Vasquez Age: 24 Weight: 200 lbs.

Rx
Acetaminophen 500mg
Temporarily relieves minor aches and pains
Temporarily relieves fever

Take two (2) tablet every six (6) hours

Store in a cool, dry place

Keep out of reach of children

Prescriber: Dr. KL
Rph. MU
Batch Number: 021448 Exp: 03/24
Storage
● Drugs to be stored under condition that prevent contamination & as far as
possible, deterioration.
● “Well closed container” precautions to be taken in relation to the effects of
the atmosphere, moisture, heat & light.
● “Protected from moisture” means that the product is to be “stored in air
tight container”
● “Protected from light” the product is to be stored either in a container made of
material that absorbs actinic light sufficiently to protect the contents from change
induced by suchlight
Signs of Instability
● Capping or Splitting
● Cracking
● Mottling
● Roughness in Tablet
● Chipping
● Abrasion or crumbling
● Softening
● Lamination
● Picking or Sticking
● Weight Variation
● Hardness Variation
● Dark Spotting
 Signs of Instability
Continued...

Capping Cracking Chipping Lamination

Mottling Sticking Dark Spotting

Weight Variation
Patient Information
● Don’t crush or break any tablets or capsules unless your doctor or pharmacist
instructs you to do so.
● Store in a cool Dry Place
● Do not Freeze
● Keep out of the reach of children
● Do not use tablets after the expiry date shown on the pack. The expiry date refers
to the last day of that month.
● Store your medicine in the original packaging in order to protect from moisture.
● Don’t store your medicine in locations that are either too hot or too cold. For
example, the bathroom cabinet may not be the best place for your medication as
it is often too hot and damp. Use a cool, lockable cupboard out of the sight and
reach of children.
Reference

Pharmapproach. (2017, November 13). Solid Dosage Forms: Tablets. Pharmapproach.com.

https://www.pharmapproach.com/solid-dosage-forms-tablets/2/

WHO. (2011). REVISION OF MONOGRAPH ON TABLETS Final text for addition to The International Pharmacopoeia.

https://www.who.int/medicines/publications/pharmacopoeia/Tabs-GeneralMono-rev-FINAL_31032011.pdf

Shrewsbury, R. P. (2009). Applied Pharmaceutics in Contemporary Compounding (2nd ed., pp. 165–188). Morton

Publishing.