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Process of Problems and Evaluation Test of Tablet Manufacturing

This document summarizes common problems that can occur during tablet manufacturing and important quality control tests for tablets. It discusses issues like capping, lamination, picking, and sticking that can happen during compression. It also describes common pre-compression and post-compression tests for tablets like hardness, thickness, weight variation, friability, disintegration, and dissolution testing. These tests are important for ensuring tablet quality meets standards before release to market. Overall, the document provides an overview of tablet manufacturing problems and quality evaluation methods.
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0% found this document useful (0 votes)
26 views4 pages

Process of Problems and Evaluation Test of Tablet Manufacturing

This document summarizes common problems that can occur during tablet manufacturing and important quality control tests for tablets. It discusses issues like capping, lamination, picking, and sticking that can happen during compression. It also describes common pre-compression and post-compression tests for tablets like hardness, thickness, weight variation, friability, disintegration, and dissolution testing. These tests are important for ensuring tablet quality meets standards before release to market. Overall, the document provides an overview of tablet manufacturing problems and quality evaluation methods.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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International Journal of Pharmaceutical Research and Applications

Volume 6, Issue 4 July-Aug 2021, pp: 1269-1272 www.ijprajournal.com ISSN: 2249-7781

Process of problems and evaluation test of tablet manufacturing


Ahmed Ali Ahmed 1 / mr,pankajchasta, Dr, Kaushal kumar chandraul,
Dr,Gaurav kumar Sharma
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Date of Submission: 01-08-2021 Date of Acceptance: 18-08-2021
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ABSTRACT 7. Objectionable odour and bitter taste can be
Tablets are the solid dosage forms which are masked by coating technique.
conventional over all pharmaceutical dosage forms. 8. Suitable for large scale production.
They are easy to prepare than any other dosage 9. Greatest chemical and microbial stability over all
forms but during their manufacturing many oral dosage form.
problems will arise which will cause discarding of 10. Product identification is easy and rapid
the entire batch and also post compression studies requiring no additional steps when employing an
also very important to release the dosage forms in embossed and/or monogrammed punch face.
to the market. In this article we mentioned what are Disadvantages of Tablet Dosage Form
the problems (Picking, Sticking, mottling etc…) 1. Difficult to swallow in case of children and
will arise during the tablet manufacturing and their unconscious patients.
remedies and also what are the Pre and post 2. Some drugs resist compression into dense
compression properties (Hardness, Thickness and compacts, owing to amorphous nature, low density
Weight variation etc….) and their limits to release character.
the dosage form in to the market. 3. Drugs with poor wetting, slow dissolution
KEYWORDS: Tablet, Pharmaceutical dosage properties, optimum absorption high in GIT may be
form, Picking, Sticking and Hardness difficult to formulate or manufacture as a tablet that
will still provide adequate or full drug
I. INTRODUCTION bioavailability.
Tablet is defined as a compressed solid 4. Bitter testing drugs, drugs with an objectionable
dosage form containing medicaments with or odor or drugs that are sensitive to oxygen may
without excipients. According to the Indian require encapsulation or coating. In such cases,
Pharmacopoeia Pharmaceutical tablets are solid, capsule may offer the best and lowest cost.
flat or biconvex dishes, unit dosage form, prepared Evaluation of Tablet1-4
by compressing a drugs or a mixture of drugs, with General Appearance The general appearance of a
or without diluents. They vary in shape and differ tablet, its identity and general elegance is essential
greatly in size and weight, depending on amount of for consumer acceptance, for control of lot-to-lot
medicinal substances and the intended mode of uniformity and tablet-to-tablet uniformity. The
administration. It is the most popular dosage form control of general appearance involves the
and 70% of the total medicines are dispensed in the measurement of size, shape, color, presence or
form of Tablet. absence of odor, taste etc.
All medicaments are available in the Tablet form Size and Shape
except where it is difficult to formulate or It can be dimensionally described and
administer. controlled. The thickness of a tablet is only
The Advantages of the Tablet Dosage Form1,2 variables. Tablet thickness can be measured by
1. They are unit dosage form and offer the greatest micrometer or by other device. Tablet thickness
capabilities of all oral dosage form for the greatest should be controlled within a ± 5% variation of
dose precision and the least content variability. standard value.
2. Cost is lowest of all oral dosage form. Unique identification marking
3. Lighter and compact. These marking utilize some form of embossing,
4. Easiest and cheapest to package and strip. engraving or printing. These markings include
5. Easy to swallowing with least tendency for hang- company name or symbol, product code, product
up. name etc.
6. Sustained release product is possible by enteric
coating.

DOI: 10.35629/7781-060412691272 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1269
International Journal of Pharmaceutical Research and Applications
Volume 6, Issue 4 July-Aug 2021, pp: 1269-1272 www.ijprajournal.com ISSN: 2249-7781

Organoleptic properties from the bottom of the beaker in their downward


Color distribution must be uniform with no movement. Move the basket containing the tablets
mottling. For visual color comparison compare the up and down through a distance of 5-6 cm at a
color of sample against standard color. frequency of 28 to 32 cycles per minute. Floating
of the tablets can be prevented by placing
Hardness and Friability perforated plastic discs on each tablet. Apparatus
Tablet requires a certain amount of showed in the Figure No.3. According to the test
strength or hardness and resistance to friability to the tablet must disintegrate and all particles must
withstand mechanical shakes of handling in pass through the 10 mesh screen in the time
manufacture, packaging and shipping. Hardness specified. If any residue remains, it must have a
generally measures the tablet crushing strength. soft mass. Disintegration time: Uncoated tablet: 5-
The apparatus showed in the Figure No.1. 30 minutes Coated tablet: 1-2 hours.

Friability Dissolution Test (U.S.P.)


Friability of a tablet can determine in Two set of apparatus
laboratory by Roche friabilator. This consist of a Apparatus-1
plastic chamber that revolves at 25 rpm, dropping A single tablet is placed in a small wire
the tablets through a Distance of six inches in the mesh basket attached to the bottom of the shaft
friabilator, which is then operate for 100 connected to a variable speed motor. The basket is
revolutions. The tablets are reweighed. Compress immersed in a dissolution medium (as specified in
tablet that lose less than 0.5 to 1.0 % of the Tablet monograph) contained in a 100 ml flask. The flask
weigh are consider acceptable. Friabilator showed is cylindrical with a hemispherical bottom. The
in the Figure No.2. flask is maintained at 37±0.50C by a constant
temperature bath. The motor is adjusted to turn at
Drug Content and Release the specified speed and sample of the fluid are
Weight Variation test (U.S.P.) withdrawn at intervals to determine the amount of
Take 20 tablets and weighed individually. drug in solutions.
Calculate average weight and compare the Apparatus-2
individual tablet weight to the average. The tablet It is same as apparatus-1, except the
pass the U.S.P. test if no more than 2 tablets are basket is replaced by a paddle. The dosage form is
outside the percentage limit and if no tablet differs allowed to sink to the bottom of the flask before
by more than 2 times the percentage limit. stirring. For dissolution test U.S.P. specifies the
dissolution test medium and volume, type of
Content Uniformity Test apparatus to be used, rpm of the shaft, time limit of
Randomly select 30 tablets. 10 of these the test and assay procedure for. The test tolerance
assayed individually. The Tablet pass the test if 9 is expressed as a % of the labeled amount of drug
of the 10 tablets must contain not less than 85% dissolved in the time limit. Apparatus showed in
and not more than 115% of the labeled drug the FigureNo.4. Inprocess Problems in tableting:
content and the 10th tablet may not contain less • Capping and Lamination
than 75% and more than 125% of the labeled • Picking and Sticking
content. If these conditions are not met, remaining • Mottling
20 tablets assayed individually and none may fall • Double impression
outside of the 85 to 115% range.
Capping and Lamination
Disintegration Test (U.S.P.) Capping is a term used to describe the
The U.S.P. device to test disintegration partial or complete separation of the top or bottom
uses 6 glass tubes that are 3” long; open at the top crowns of a tablet from the main body of the tablet.
and 10 mesh screens at the bottom end. To test for Lamination is the separation of a tablet in to two or
disintegration time, one tablet is placed in each more distinct layers.
tube and the basket rack is positioned in a 1-L
beaker of water, simulated gastric fluid or Picking and Sticking
simulated intestinal fluid at 37 ± 20 C such that the Picking is a term used to describe the surface
tablet remain 2.5 cm below the surface of liquid on material from a tablet that is sticking to and being
their upward movement and not closer than 2.5 cm removed from the tablet’s surface by a punch.

DOI: 10.35629/7781-060412691272 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1270
International Journal of Pharmaceutical Research and Applications
Volume 6, Issue 4 July-Aug 2021, pp: 1269-1272 www.ijprajournal.com ISSN: 2249-7781

moment of compression the tablet receives the


Mottling Mottling imprint of the punch. Sometimes it will receive
is an unequal distribution of colour on a tablet, with double impression due to improper movement of
light or dark areas standing out in an otherwise lower punch. Preventive methods:
uniform surface. • By proper mixing
• By improving the flow properties of granules
Double impression • By using proper camtracks which are responsible
This involves only punches that have for punches movements.
monogram or other engraving on them. At the

II. CONCLUSION
Tablets are the conventional dosage forms
and they are also widely using dosage forms due to
FIG: 3 many advantages over other dosage forms. During
their manufacturing many inprocess problems and

DOI: 10.35629/7781-060412691272 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1271
International Journal of Pharmaceutical Research and Applications
Volume 6, Issue 4 July-Aug 2021, pp: 1269-1272 www.ijprajournal.com ISSN: 2249-7781

also after formulation also problems will arise. By


using proper preventive methods we can reduce
those problems or we can make them in standard
limits.

III. ACKNOWLEDGEMENT
The authors are sincerely thanks to the
B.pharmacy department Mewar university gangrar,
chittorgarh, Rajasthan, Indiafor providing the
facilities to complete this review article.

DOI: 10.35629/7781-060412691272 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1272

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