Download to read ad-free.

AD

Search EN Upload Read free for 30 days

What is Scribd? Academic Professional Culture Hobbies & Cra s Personal Growth All Documents

 0 ratings · 3K views · 9 pages

Tablet Manufacturing Process
Uploaded by Nurul Faizaah

Process of manufacturing tablets Full description

     
Save 0% 0% Embed Share Print

Download now 1 of 9  Search document 

• Flow chart:

Dispensing Sizing Milling

Blending

Coating compress Drying

TABLET MANUFACTURING PROCESS

– Dispensing: (the ingredients/ components) are gathered and each

component is weighed to the precise amount needed).

– Sizing operation: (which grades the incoming API (active

pharmaceutical ingredient).

– Miing operation: which aims to deliver the API with uniform particle
size!

– Ben"ing operation: which mixes the milled API with a number of

inactive ingredients with the goal of delivering a uniforml blended
material

– Gran#ation: !hen the blending phase is completed" the product is

ta#en out of the blender and the granules are prepared in a granulator
or direct to compression.

– Dr$ing: the granules prepared are dried in a drer

– Co%pression operation: which aims to produce tablets with target

hardness characteristics.

– Coating operation: that delivers the final product$a coated tablet.

– Pa&'ing: pac#aging in the final container or strip or blisters

AD Download to read ad-free.

AD Download to read ad-free.

%&'*+ ,- P-&PA-A'I , 'A0&'+

You're Reading a Preview

• Tere are tree ()* %eto"s +$ ,i& te ta+ets &an +e prepare"
Upload
1. your documents
Dire&t to download.
Co%pression
2. Dr$ Gran#ation
3. Upload
-et to Download
Gran#ation

DR. BLENDING : OR

!&I4I4
Become a Scribd member to read and download
+I5I4 full documents.
0&*I4
06-I7A'I
Start your 30 day free trial
7%P-&++I
7A'I4

DR.
GRANULATION :

!&I4I4
+I5I4
0&*I4
7%PA7'I
%I00I4
06-I7A'I
7%P-&++I

-ET GRANULATION :

!&I4I4
+I5I4
4-A60A'I
*-8I4
0&*I4
06-I7A'I
7%P-&++I

AD Download to read ad-free.

1. DR. GRANULATION
You're Reading a Preview
• Upload
In dr granulation" your
the dr documents
powder toma
particles download.
be brought together
mechanicall via &o%pression to /or% s#gs" or more fre9uentl via
Upload to Download
compaction b a roller compactor.

• 'his method has been utilized when

OR one of the constituents" either the drug or
the excipients has insufficient &oesi0e or /o, properties to be directl
compressed into tablets.
Become a Scribd member to read and download
full documents.
• *r granulation is a valuable techni9ue in situations where the effective dose
of drug is too high for direct
Start compression and
your 30 day free the drug is sensitive to heat"
trial
moisture or both" which precludes wet granulation (ana#er" 1:;:< 1::1).

-ET GRANULATION

• !ith wet granulation" extra process steps are necessar to produce a tablet
mass with sufficient tableting properties.

• After dr blending the tablet mixture to uniformit" a binder solution is added
to the mixture to moisten the particles.

• Introduction of the binder solution improves binding between the particles and
therefore can produce stronger tablets.

• %ixing is continued until granules with a specific diameter are produced.

• 'his wet mass is then screened to remove large lumps" and dried in oven to
remove granulation fluid.

• ,inall" the granules are sieved to remove the agglomerates that are formed
during dring followed b lubrication of the granules.

AD Download to read ad-free.

Dire&t Co%pression
•
You're Reading a Preview
'he other techni9ue for tablet production is direct compression

•
Uploadall
In direct compression" your
thedocuments to download.
powder mixture is blended to form a uniform
mixture and is directl compressed into tablets without an modification of its
phsical nature. Upload to Download

• OR
0ubrication step ma be necessar to prevent the mixture from adhesing to
the die and punches during compression.

Become a Scribd member to read and download

 full documents.
'ablets are compressed directl from powder blends of the active ingredient
and suitable excipients
Start your 30 day free trial
 o pretreatment of the powder blends b wet or dr granulation procedures is
necessar

 Additives=
 *iluents
 *isintegrating agents
 rganoleptic additives
 4lidants" anti>adhesives" lubricants

AD Download to read ad-free.

P-&PA-A'I , +,' 7AP+60&

You're Reading a Preview
+oft capsules are generall prepared in two methods
1) Plate process" Upload your documents to download.
2) -otar die process
Upload to Download
P0A'& P-7&++
? In the plate process a warmed sheet of plasticized gelatin is placed over a
OR
plate having a number of depressions or moulds.
? 'he sheet is drawn into these moulds b appling vacuum.
Become a Scribd member to read and download
? A measured 9uantit of li9uid medicament is poured over it.
full documents.
? 'hen another sheet of gelatin is placed over it and the pressure is then
applied to the combined plates.
Start your 30 day free trial
? 'he capsules are then simultaneousl shaped" filled" sealed and cut into
individual units.

-'A-8 *I& P-7&++

? In this process filled capsules are produced continuousl and automaticall.

? 'wo continuous sheets of gelatin are supplied to the die rolls of the machine
which has a number of matching dies and rotate at the same speed and in the
opposite direction.
? 'he pressure exerted b the material forces gelatin sheet to go in the cavities
of the die rolls to form two halves of the capsule and fill them.
? 'he heat and pressure exerted b the die rolls seals and cuts out the
capsules.
? 'he finished capsules are then passed through a series of naphtha baths to
remove lubricants and then dried.
? 'hese rotar die machines are produce 2@ to 3 capsules per hour.

Fig#re: -otar die machine for producing soft capsules

AD Download to read ad-free.

PBA

You're Reading a Preview

 Pharmaceutical Bualit Assurance ma be defined as the responsi+iities o/
Upload
an organization your documents
to determine to/a&iitates
the s$ste%1 download. 2 ,ritten pro&e"#res
are both ade9uate and followed in order to assure that products are controlled
C met in the final dosage Upload tothe
forms all Download
applicable specifications.

 +um of all activities and responsibilities

OR re9uired to ensure that the medicine
that reaches the patient is safe" effective" and acceptable to the patient.

Become a Scribd member to read and download

full documents.
 Bualit assurance personnel must establish control or" chec# points to
monitor the 9ualit of the product as it is processed C upon completion of
Start your 30 day free trial
manufacture these begin with raw materials C component testing and
includes=

 in3pro&ess1
 pa&'aging1
 a+eing1 an"
 /inise" pro"#&t testing
 as ,e as +at& a#"iting an" sta+iit$ %onitoring!

'he need for PBA

 assuring the 4#ait$1 sa/et$1 p#rit$ an" e//e&ti0eness of the drug suppl.

 assures that at each stage of manufacturing the necessar test are made C
the product is not released until it has passed these tests.

 'o ensure the correct C most appropriate manufacturing C pac#aging

practices.

 'o assure that the testing results are in compliance with the standards or"
specifications

 'o chec# the maintain of the department premises C re9uirements"

AD Download to read ad-free.

MATERIAL MANAGEMENT You're Reading a Preview

Upload your documents to download.
Material management is defned as an organizational concept, which
has the authority and responsiility o! all acti"ities, concerned with
Upload to Download
the #ow o! materials in the organization$

OR
It is concerned with planning, organizing and controlling the #ow o!
materials !rom their initial purchase through internal operations to
Become a Scribd member to read and download
the ser"ice point through distriution$
full documents.

Material management is a scientifc techni%ue, concerned with

Start your 30 day free trial
&lanning, 'rganizing ( )ontrol o! #ow o! materials, !rom their initial
purchase to destination$

The aims o! material management are !ollowing*

+$ To get the right %uality
$ To get right %uantity o! supplies
-$ To get at the right time
.$ To get at the right place
/$ To get 0or the right cost

The purpose o! material management are !ollowing*

+$ To gain economy in purchasing
$ To satis!y the demand during period o! replenishment
-$ To carry reser"e stoc1 to a"oid stoc1 out
.$ To stailize #uctuations in consumption
/$ To pro"ide reasonale le"el o! client ser"ices

AD Download to read ad-free.

RA2 MATERIAL You're Reading a Preview

Upload your documents to download.
RA2 MATERIAL3 is asically the chemical ingredients o! a process$

Upload to Download
4asic raw materials are starting material, which is used in
production o! fnal product$
OR

Good raw material specifcations must e written in precise

Become a Scribd member to read and download
terminology, must e complete, must pro"ide specifc details o! test
full documents.
methods, type o! instruments, and manner o! sampling, and must
e properly identifed$ Start your 30 day free trial

)RITERIA 0'R RA2 MATERIAL 5 0IN6  M'RE 7

It must e noted that &harmacopoeial standards are minimum$

2here no such standards are applicale to raw material, the

specifcations should include at least re%uirements !or identifcation,
limits !or purity and potency and limits !or impurities$

2here such standard e8ist !or raw material, alternati"e test

methods may e used ut there should e written e"idence to show
that such method are at least as precise and specifc as the o9cial
methods$

AD Download to read ad-free.

You're Reading a Preview

Upload your documents to download.
:)
 :uality control 5:$)7 wor1s !rom the raw materials up to
Upload to Download
fnished products which is assures that at each stage o!
manu!acturing the necessary test are made ( the product is
OR
not released until it has passed these tests$

Become a Scribd member to read and download

 It is that part o! GM& concerned with sampling, specifcation
full documents.
( testing, documentation ( release procedures which ensure
that the necessary
Start(your
rele"ant
30 day freetests
trial are per!ormed ( the
product is released !or use only a!ter ascertaining it;s %uality$

 'perational laoratory techni%ues and acti"ities used to !ulfll

the re%uirement o! :uality

 :) is la ased

:A

 It is the sum total o! the organized arrangements with the

o<ecti"e o! ensuring that products will e o! the %uality
re%uired !or their intended use$
 All those planned or systematic actions necessary to pro"ide
ade%uate confdence that a product will satis!y re%uirements
!or %uality

 :A is company ased

Reward Your Curiosity

Everything you want to read.
Anytime. Anywhere. Any device.

Read free for 30 days

No Commitment. Cancel anytime.

Share this document

    

Related titles

From Everand From Everand From Everand Document Document Document D

Pharmaceutical Good Pharmaceutical Tabros Cream & Ointment Santhosh Manual T

Industry… Manufacturing… Quality Assuran… Pharmaceutical… Process Validation Added by… A
Chandrasekhar Panda Chandrasekhar Panda K. P. Bhusari Added by Anum… Added by tajmir haque

0 ratings 0 ratings 0 ratings

0 ratings 0 ratings 0 ratings

Documents  Science & Mathematics  Chemistry

About Suppor t Legal Social Get our fr ee apps

About Scribd Help / FAQ Terms Instagram

Everand: Ebooks & Audiobooks Accessibility Privacy Twitter

SlideShare Purchase help Copyright Facebook

Press AdChoices Cookie Preferences Pinterest

Join our team! Do not sell or share my personal

information
Contact us

Invite friends

Scribd for enterprise

Documents
Language: English Copyright © 2024 Scribd Inc.

We and our 10 partners store and access information on your device for personalized ads and content. Personal data may be processed, such as cookie identifiers, unique device identifiers, and
browser information. Third parties may store and access information on your device and process this personal data. You may change or withdraw your preferences by clicking on the cookie icon or link;
however, as a consequence, you may not see relevant ads or personalized content.
Our website may use these cookies to:
Measure the audience of the advertising on our website, without profiling Customize Your Choices
Display personalized ads based on your navigation and your profile
Personalize our editorial content based on your navigation
Accept All
Allow you to share content on social networks or platforms present on our website
Send you advertising based on your location
Continue Without Accepting
Privacy Policy
Third Parties

Storage Targeted Advertising Personalization Analytics