UIE OA

LABORATE
INDUSTRIAL TRAINING REPORT
ON
PRODUCTIONOF TABLETS'
AT LABORATE PHARMACEUTICALS LTD.

Submitted in partial fulfillment of the requirement for the award of degree of

Bachelors of pharmacy

Session 2019-2023

Under the supervisionof: Submitted by:

Mr. Shambu Nath Jha Ronak Bhambri

(Head Chemist) B Pharmacy

Laborate PharmaceuticalsIndia LTD. BPH_ 1925
E-11Industrial Area, Regn. No: 19-GIPN-27

Panipat-132103

Haryana

Geeta Institute of Pharmacy Naultha,Panipat

(Affiliated to pt. B.D. Sharma University, Rohtak)

 DECLARATION
hereby declare that work presented in the industrial

training report entitled in INDUSTRIAL TRAINING PERFORMED AT Laborate

Pharmaceuticals Paninat. an authentic ccord of work carried out by me during
Pharmaceuticale Paninat md
Laborate

it
guidance of Dr. Sunil Jawla (principal of geeta institute of pharmac ls being submitted for

partial fulfilment ofthe requirement for the award of bachelordegree in B. pharmacy. This has

not been submitted whereelse for the

anywhere awardofany other degree/diploma.

Signature of head of the department

Mr. Shambu nath Jha

Production chemist
 TRAINING CERTIFICATE

LABORATE
PHARMACEUT

Ref. no. : LPVPNPIc2022/16

Date: 1012/2022

TRANING CERTIFCATE

industry. Our
LABORATE is one of the fastest growingcompanies in the Indian pharmaceutical

high quality drugs and pharmaceutical formulations are supplied throughout the country and
and
more 35 nations We have been honoured with varous

I
to than across the globe.

international awards for excellence in produetivity, innovation and managenment.

work atmosphere to employees to ensure an optimum level

LABORATE provides a conducive its

are immensely bright professional

of productivity fron them. Also the trainees and apprentices

careers.

Pharna from Geeta Institute of Pharmaey has undergone

Mr. Ronak Bhambri Students B.

from date 1o/11/2022 to 1o/12/2o22 at our Head

training in our Q.e & Production Department

enormous interest in learning the

office situated at Panipat. During his training, he demonstrated

fundamentals & intricacies of Project Management and Negotiation,

was As visible from his

throughout the training and his eonduct remarkable.
He was impressive
career ahead and will certainly prove to be
performance with us, he has a promising
disciplined

asset for any organization he serves in future.

an
For Laborate Pharrfaceuticala tdbyi

Authorized Signäfory
Date: 10.12.2022

Place: Panipat

LABORATE PHARMACEUTICALS INDIA LTD.OPLCO30835

Regd. Office. :E-11, IndustrarcE0 2651248.
2650385, 2655741, 2655742
Works :51,Industrial Area, Gondpur, :
Paonta Sahib (H.P) Tel. 01704-265047/62/63
Works 31, Rajban Road, Nariwala, Paonta Sahib (HP) Tel. 01704-266173-4 :
:
E-mail laborate@laborate.com Website:Visit us to www.laborate.com
:
 ACKNOWLEDGEMENT
It is ofpleasure and happiness to make and submit this industrial trainingreport during
a matter
the course of the comnletion of this industrial work Many of the nersons have offered their
valuable
and anetion
port.
to all my teachers
mthankful
he
ofCate institute ofpharmac
P

Panipat Eor shot ment, would like to express my special thanks and

I
eratitude to als and
Laborate Pharnaceuticals Mr. Shambu nath iba (production chemist) for

roviding all the essential

Prov facilities which were required for this training. Finally, express my

I
gards to my beloved parents who inspired me throughout my studies and completion of this
training

I am highly gratefulto my project guide Dr. Sunil jawla (principalgeeta institute of

pharmacy) for their inspiring presence and blessing for going ahead and fulfilling the project
report.

Lastly I thank faculty and staff menmbers of GIP, Panipat which gave me an opportunity
regarding training purpose and helped me in building some experience in my career

Date

Place:

Student name:
 INDEX

S.no. Pg.no.
troduetion
Product list

Tablet formulation process

4 Sizing
Powder blending
6 Granulation 6
Drying 7
8 |Tablet compression
9 |Tablet coating
Physical features of compresscd tablets
Packaging 13

Evaluation of tablets

My learning at laborate pharmaceutical

Conclusion 2:
Reference
 LIST OF FIGURES
Content Pg.no.
S.no.
IUltra king tablets

Augulab625 tablets
|Tablet formulation 3
on process
4 |Ribbonblender
|Doublecone blender
6 Types of tablets 12
7 Kind ofpackaging 4
8 Blister packs
9 Bottle packaging
10
Ampoules packaging
Vials packaging
|Sachet packaging 14

LIST OF TABLES
s.no, content Pg.no.
Defects in tablet coating

Physical features of compressed tablets

LIST OF FLOW CHARTS

|s.no. content Pg.no.
Heat transfer modes of dryers
 INTRODUCTION
ABOUT LABORATE PHARMACEUTICALS
Laborate Pharmaceuticals is one of the fastest growing pharmaceutical companies in India.
Over the years, we have been awarded and recognized for our endeavor to nanufacture
premium quality products and sell it for economical price. We believe that healtheare is not a

privilege but a right ofevery citizen. Thus, we are taking giant strides in making good quality
products available in rural as well as urban areas. We manufacture an extensive range of
products, Currently, our range ofover 1000products varies from Generic Pharma Products to

Ayurvedie and Personal Care Products

Quality Control and Quality Assurance

Ever since our inception in 1985, Quality Control and Quality Assurance has been at the core

ofour business operations. We understand ourduty towards the society for manufacturing only
premium quality products. Therefore, we have set up an independent department for Quality
Control and Assurance. Morcover,our ultra-modern testing facility is cquipped with GC, FTIR,
HPLC, UV and other techniques complying with international Pharmacopocia requirements

Awards

Over the years, ourgood work has been recognized by several reputed organizations, and they
have bestowed us with important awards. Here's a list of few of them:

'Emerging India Award'by ICICl and CNBC, 2008

Udyog Rattan Award'

'Excellence Award'by Institute of EconomieStudies (IES), 2008

State of the art Infrastructure

Our 3 world class manufacturing facilities are approved by WHO GMP and FDA of 35other
countries, and are made as per the guidelines of US-FDA and UK-MHRA. Our multipurpose
plants can manufacture sterile and nonsterile products. We also have exclusive dedicated

blocks for p-lactam and non B-Lactam antibiotics.

Take a look at our daily production capacity:

•Liquid Injections: 200,000 vials and 300,000 ampoules

•Ophthalmic: 300,000

•Dry Injections: 300,000

TopicalPreparations: 200,000 tubes

Tablets: 15 Million units

•Capsules: 2 Million units

•Dry Syrup: 100,000 Bottles

 PRODUCT LIST
ABIDE ABIDE 400mg Tablet I's

2. ACEFEN MR Acefen MR Tablet 10'S

3. AMILABAMILAB S00 Injection 1's

ASTOZYME Astozyme 200ml up

5. AUGULABAUGULAB 625mg Tablet 10s

6. BECLOLAB NCBECLOLAB NC Cream Sgm I

7, CAL D3CAL D3 500mg Tablet 10'%

8, CAL D3 Tablet 15's
9, CEFLOX LEFLOX 250 mg Tablet 10's
10, CEFLOX EyeEar Drops 10ml

I1. CEFLOX CFCEFLOX CF Cream 15gm

12. CEFLOX DECIPLOX D EyeEar Drops 10ml

13.CEFLOX DEE OPTICCEFLOX DEE OPTIC Eye/Ear Drops 1Oml

14. GENTACORT D'GENTACORT D Eye/Ear Drops 1Oml

15, GENTALABGENTALAB 40 Injection 30ml

16. GENTALAB Injection 2ml
17, GENTALAB Gentalab Eye/Ear Drops 1Oml
18. HUNGREE Hungered Syrup 200ml
19. HUNGREE pineapple flavor HUNGREE PINEAPPLE FLAVOUR Syrup200ml
20.HungreeElaichi Flavor HUNGREE ELAICHI FLAVOUR Syrup 200ml
21, Hungree Mango Flavor HUNGREE MANGO FLAVOUR Synup200ml
22. ITROZOLEITROZOLE 100mg Capsule 4's
23, KT 5 DERMOT 5 DERM Cream 15gm
24. LABCHLOR LABCHLOR Capsule 10's
25. LABDIC RELIEF LABDIC RELIEF Gel 30gm
26. LABOCOF Labocof Tablet 10s
27. LABOCORTLABOCORT I00 Injection I's

Tramadol &
Acetaminophen Tablets

JULTRA Atoclin and

Claiate Tokts

KING Potassun
tLP
Augulab-625

1xt5 Tatiet

FIG, NO., 01 FIG, NO. 02

ULTRA KING TABLETS AUGULAB-625 TABLETS

 CHAPTER-1
TABLET FORMULATION PROCESS
The manufacture of oral solid dosage forms such as tablets is a complex multi-stage process
under which the starting materials change their physical characteristics a number of times
before the final dosage form is produced.

Traditionally, tablets have been made by granulation, a process that imparts two prinmary

requisites to formulate: compatibility and fluidity. Both wet granulation and dry granulation
(slugging and roll compaction) are used. Regardless of whether tablets are made by direct

compression or granulation, the first step, milling and mixing, is the same;subscquent steps
differ.

Numerous unit processes are involved in making tablets, including particle size reduction and

sizing, blending, granulation, drying, compaction, and (frequently) coating. Various factors

associated with these processes can seriously affect content uniformity, bioavailability, or
stability.

Tableting is a method of pressing medicine or candy into tablets, Confectionery manufacture

shares many similarities with phurmaceutical production.

A powder or granule misture is prepared, a dye mold is filled, and then the mixture is

compressed and cjected. While drug tablets are constraincd to shapes and sizes that can be
swallowed casily, candy tablets are designed to be chewable and can take a wider variety of
shapes and sizes.

Dipensne Dspensne

WET GRAN

Ory Min Ming

Gran

tablesPrvs
Bed
Tubes Coater
Dre

Conkca

Dry Ma

FIG, NO. 03

TABLET FORMULATION PROCESS

3
 CHAPTER-2
SIZING

Sizing (size reduction, milling, crushing, grinding, pulverization) is an important step in the

process oftablet manufacturing.

Inmanufacturing ofcompressed tablets, the mixing or blending of several solid pharmaceutical

ingredients is easier and more uniform ifthe ingredients are about the same size. This provides
a greater uniformity of dose. A fine particle size is essential in the case of lubricant mixing
with granules for its proper function.

Advantages of smaller tablets are as follows:

. Increased surface area, which may enhance an active ingredient's dissolution rate and hence
bioavailability

Improved tablet-to-tablet content uniformity due to a larger number of particles per unit
weight
. Controlled particle size distributionof dry granulation or
mixture in tablet machine
mix to promote better flow of

Improved flow properties of raw materials

. Improved color and/or active ingredient dispersion in tablet excipients

. Uniformly sized wet granulation to promote uniform drying

The following problems may arise if the process is not controlled properly:

.A possible change in polymorphie

inactive,or unstable
form ofthe active ingredient,rendering it less ortotally

A deerease in bulk density ofactive compound and/or excipients, which may cause flow
problem and segregation in the mix
An inerease in surfce area from size reduction may promote the adsorption ofair, which
may inhibit wettability of the drug to the extent that it becomes the limiting faetor in

dissolution rate

Various types of machine may be used for the dry sizing or milling process, depending on
whether gentle sereening or particle milling is needed. The range of cquipment employed for

this process includes:

Fluid energy mill

Colloidal mill

Ball mill
Hammer mill
Cutting mill
Roller mill
Conical mill
 CHAPTER-3
POWDER BLENDING
The successful mixing of powder is more difticult than mixing liquid, as perfect homogeneity
is dificult to achieve. Another problem is the inherent cohesiveness and resistance to
movement between the individual particles. The process is further complicated in many
systems by the presence of substant ial segregation influencing the powder mix. This arises
from the difference in size, shape,and density ofthe component particles. The powder/'granules
may be blended at the pre-granulation and/or post-granulation stage of tablet manufacturing.
Each process of mixing has an optimum mixing time, and longer mixing may result in an
undesired product. The optimum mixing time and specd must be evaluated. Blending prior to
compression is normally achieved in a simple tumble blender. This be a fixed blender into

from which the container (bin) can be removed and brought directly to other processing
steps, In special cases of mixing a lubricant,overmixing should be particularly monitorcd.
The various blenders used include the "V" blender, oblicone blender, container blender,
tumbling blender, and agitated powder blender.
Nowavs,
imnroved
to ontimize the
manutacturing process
nieces ofeauinment which combi
a
particularly in wet granulation, various
tons (mixing, eranulation
and/or drying) are used. These arethe mixer granulator and high shear mixing machine.

FIG.NO,04 FIG.NO,05

Stainless Steel Industrial Ribbon Blender Double Cone Blender

Mixer, Capacity: 100-200 Kg Per Hours

5
 CHAPTER-4
Granulation

The granulation process is "any process whereby small particles are gathered into larger,

permanent masses in which the original particles can still be identified." This definition is of

course particularly appropriate to a pharmaceutical granulation where the rapid breakdownof

agglomerates is important to maximize the available surface area and aid in solution of the

active drug. The granulation process of size enlargement used within the pharmaceutical
industry has its roots in ancient times. The practice of delivering medicinal powder by hand
rolling into a pill by using honey or sugar has been used for centuries.

is still the practice to deliverthe botanical and herbal cxtract in homoeopathic and Ayurveda
It
branches of medicine, which are still practiced in India along with allopathic medicine. The
term "granulated" material is derived from the Latin word"" meaning grained. The granular
material canbe obtaincd by direct size enlargement ofprimary particles, or size reduction from
dry compacted material in modern times, granulation technology has been widely used by a

wide range of industries, such as coal mining, and agrochemical These industries employ
agglomeration techniques to reduce dust, provide a case ofhandling, and enhance the material's

ultimate utility.

The development of pharmaceutical granulation was driven by the invention ofthe tablet press
by W. Brockedonin 1843. Subsequent improvements in the tablet machinery were patented in
the United States by J. A. Mc. Ferran (1874), T. J. Young 1874), and J. Dunton (1876). The
demands on the granulation properties were further enhanced in the 1970s as high-speed tablet
and capsule filling machines with automated controls were introduced. The continuous
refinements in the regulatory requirements such as low-dose products requiring blend

uniformitylcontent uniformity neccessitated knowledge and technology to produce the required

granule characteristics.

The high-speed compression and capsule filling machinesrequire a uniform flow of material
to the dies or filling stations that produce pharmaceutical dosage form.

Granulation is an example of particle design. The desired attributes ofthe granule are controlled
by a combination of the formulation and the process.

Granulation methods can be divided into two major types: wet methods which utilize some
form of liquid to bind the primary particles, and dry methods which do not utilize any liquid

1-Receive the raw material as BMR from Raw material store

2-Shiting of rawmaterial (APIl & EPI) in sifter

6
 CHAPTER-5
DRYING
Drying is an important step in the formulation and development of a pharmaceutical product.
is important to keep the residual moisture low enough to prevent product deterioration and
It
ensure free flowing properties. The commonly used dryers include the fluidized-bed dryer,
vacuum traydryer, microwavedryer, spray dryer, freeze dryer, turbo-tray dryer, and pan dryer.

Drying is the process of removing the presence of solvents (ie. water or other liquids) in a

formulation with the presence of heat. The final product of this unit operation is a dry solid

mass or powders. This process is widely used in the plharmaceutical field, from research and
development phase until large-scale manufacture.

It is important to havea good understanding of this process' impact on the quality attributes of
the active pharmaceutical ingredient (API)in order to guarantee will not have any adverse i

impact on the drug's safety and efficiency, thus, providing high quality final products.

All drying processes of relevance to pharmaceutical manufacturing involve evaporation or

sublimation of the liquid phase and the removal ofthe subsequent vapor.

Drying ofr Wet Solids: Conveetive Drying of Wet Solids: This method utilizes dynamic
convective dryers (e.g., Fluidized-bed dryer) to obtain good contact between the warm drying
air and wet particles in the fluidized-bed dryer

The fluidized-beddryer was developed for the process offluidization to improvethe efficiency

ofheat transfer and vapor removal, ascompared with the older statie tray dryers.This fluidized
bed dryer also allows the efficient transfer of the latent heat of evaporation from the air and

into the drying solid,

Advant sof fluidized-bed

Shoren
the efficient heat and mass transfer, allowing high product
output with smallfootprint.
o Minimizes heat challenge to thermolabile materials
o The turbulence in a bed causes some gnaws
fluidized the surface of the granule, thus,

producing a more spherical free-flowing product.

DRYERS

Heat transter mode

Convecton Coeducion Radiaton Delectric Combined modes

Fas Drum dryer Infrared shelf dryer Microwave oven

Merowave Convetve
Mier
dryer Sun dryer
Fuidbed dver Rotay dr Intrared convective dryer
Radiotequency dryer
Cabinet dryer Radiofrequency assisted heat
Travs dryer
Tunnel dryer pump dryer

Koary drye

FLOWCHART NO.01
HEAT TRANSFER MODES OF DRYERS
 CHAPTER-6
TABLET COMPRESSION
Tablet press
After the preparation of granules (in wet granulation) or sized slugs (in dry granulation) or
mixing ofingredients (in direct compression), they are compressed to get the final product, The
compression done either by a single-punch
is machine (stamping press) or by a multi-station

machine (rotary press). The tablet press is a high-speed mechanical device. It squcezes the

ingredients into the required tablet shape with extreme precision. It can make the tablet in many
shapes, although they are usually round or oval. Also, it can press the name of the manufacturer
or the product into the top of the tablet.

Stage 1: Top punch is withdrawn from the die by the upper cam, Bottom punch is low in the
powder falls in through the hole and fills the die.
die so
Stage 2: Bottom punch moves up to adjust the powder weight. It raises and expels some
powder.
Stage3: Top punch is driven into the die by upper cam. Bottom punch is raised by lower cam.
Both punch heads pass between heavy rollers to compress the powder.
Stage4: Top punch is withdrawn by the upper cam. Lower punch is pushed up and expels the
tablet, which is removed from the die surface by surface plate.

Stage 5: Return to stage 1.

Tablet testing
roperties ofa tablet are tested either by manualor automated sampling and IPC
testing (in-process contro), Tablet "hardness", also called "breaking force", is tested toassure
that the tablet's strength will survive all further processes, such as dedusting, coating and
packaging. The hardness value ofa tablet gives an early indication of the tablet's disintegration
time. Further measured parameters are weight, thickness, dameter, disintegration time,
friability, and abrasion.

Friability and abrasion testing is performed in rotating testing drums, designed according to

the pharmacopeia. The measured parameter is weight loss before and after testing and tumbling
the tablets at a particular time and specd. In the friability test drum tablets are being carried up
by a "shovel" and dropped. Tablets are also not allowed to fall apart during the test. In the

abrasion test,drum tablets are not falling/dropping,but rolling on the ground of the test drum
and losingg weight due to the friction between tablets.

Tablet deduster

In almost all cases, tablets coming out ofa tablet machinehave excess powderon their surface
which is removed by passing them through a tablet deduster.

Fette machine
The Fette muchine chills the compression componentsto allow the compression oflow-melting
point substances such as waxes, thereby making it possible to compress products with low
melting points.
 CHAPTER-7
TABLET COATING
Tablet coating is the process where coating material is applied to the surface of the tablet to

achieve the desired properties of dosage form over the uncoated variety. The advantages of
coating are listed below.
•Improving taste, odor, and color of the drug
•Improving case ofswallowing by the patient
•Improving product stability
rie environment
To inprovemeehanical resistance of the dosage form
•Modifying release propertis

There are three main processes for tablet coating: sugar coating, film coating, and enteric
coating. Various classes of pharmaceutical coating materials used in tablet coating depending
on the phase of coating are reached. Coating materials can be categorized as follows:
•Binders (acacia, gelatin, cellulose derivatives)
•Fillers (caleium carbonate, titanium dioxide, talc)

Colorants (dyes, iron oxides, titanium dioxide)

Antiadhesives (tale)

Sugar coating
ating, sugar coating is a more laborious multistep process, leading to final tablet
weight inereas up to 30%-S0%,significantly inereasing tablet size. The process ofsugar
coating involves various steps, ie., sealing, subeoating, smoothing, coloring, and polishing.

Sealing
A seal coat is applied over the tablet core to protect against water penetration into the tablet
from the sucrose coatings to folow. Hence, it offers good stability of product and can also
strengthen the tablet core. Sealing coat consists of Shellac, cellulose acetate phthalate (CAP),
polyvinylacetate phthalate (PVAP), hyroxylpropyl cellulose, hyroxypropyl methylcellulose
(HPMC), and Zein (a corn protein derivative). Shellac was previously used as a scalant.
However, this has largely been replaced by zein CAP and PVAP due to polymerization
problems. Theamount ofsealing coat material depends on tablet porosity and batch size; hence.
optimizing the quantity ofsealing coating applied is very important to ensure tablet cores are
sealed effectively.

Subcoating
Subcoating is performed to round the tablets edges, In this process, there is a significant

increase in tablet wveight, Generally, lamination process and suspension process methods are
used for subcoating. In lamination process, the subcoat mixture consists ofsucrose and binder
solution such as acacia or gelatin, which is applicd over the tablet surface followed by powder
containing materials such as calcium carbonate, titanium dioxide, caleium sulfate, and talc.

Finally,drying air is applied in order to evaporate the water. During the suspension process, a

suspension of fillers in gum solution is applied. After that, sucrose solution is applied followed
by drying. Suspension process is suitable for automatic methods.

Smoothing
process is applied in order to smoothout subcoated rough surfaces and to increase
tablet bulk keod size Smoothing generally consists of 60%-70% sugar solid, In

some cases, however, syrup also comprises acacia, gelatin, pigments, starch, or opacifier.
Smoothing is performed many times (about 10 cycles), until tablets are suitable for the next
(coloring) phase.

Colo
oloring
phase is a significant in sugar-coating rocess, which gives the tablet improved
appearance and stability, Sugar-coating solution consists of 70% syrup and other coloring
pigments. Previously water-soluble dyes (coloring agents) were mainly used as for sugar
coated tablets. However, water-soluble dyes are generally associated with color migration
problems, and dyes usually transfer to the surface of the tablets during drying. Hence, the use
of water-insoluble pigment (lakes)has now replaced the dyes,which provides even tablet color

and maintains batch-to-batch color uniformity.

Polishing
Generally sugar-coated tablets are dull in appearance: polishing gives the characteristic surface
shine and tablet elcgance. Polishing is performed in polishing pan using the beeswax,carnauba
wax,and candelila wax mixture.

Film coating
Film coating is single-stagecoating process and needs a relatively short time and so is favored
over sugar coating, Film coating is the deposition of a thin film of polymer (betwcen 20 and
100 um) applied mainly to tablets;in addition, film coating can also be applied to hard and soft

gelatin capsules and multiparticulate system. Film-coating formula generally consists of

polymers, plasticizer, colorants/opacifiers,solvents,etc. Table 5 depicts commonly used film
and enteric-coating materials.

10
 CHAPTER-8
Physical featuresof compressed tablets

Compressed tablets can be round, oblong. or unique thin; large or small in

in shape; thick or
diameter:; lat or convex; unscored or scored or quadrants; engraved or
in halves, thirds,

imprinted with an identifying symbol and/or code number;coated or uncoated; colored or

uncolored; one, two, or three layered.

Tablet diameters and shapes are determined by the dies and punches used in compression. The
less concave the punches, the flatter the tablets; conversely, the more concave the punches, the

more convex the resulting tablets. Punches with raised impressions produce recessed
impressions on the tablets; punches with recessed etchings produce tablets with raised
impressions or monograms,Logos may be placed on one or on both sides ofa tablet, depending
on the punches.
Hard
Content |Fria-|
Formulae Weight ness
bilityUniformity
Wetting
Time DT
Code Variation (sec)
(k/em' (%) (%) (sec)
FI 4.5 |4.2+0.45 0.7299.32+1.39 40+4 72+5
F2 3.9 0.5898.79tl.86
1.9+0.68 8+2 30+7
F3 4.2 .6+0,39 0.6799.87+0.27 12+3 36+9
F4 4.9 4.9+0. 13 0.53 99, 19+0,63 15+4 42+4
FS 4.7 0.59 98.54+0,98
1.5+0.75 20+3 |51+7
F t 3.8 4.7+0,29 0.69 99.57+O.23 17+2 46+5
F7 t 4.6 |4.9+0.58 0.7199.39+0,75 48+6 76+8
F8 4.2 |4.4+0.39| 0.7999.57+0.71 17+3 44+3
TABLE NO, 02
PHYSICAL FEATURES OF COMPRESSED TABLETS

Eyemtatt

FIG.NO. 06
TYPES OF TABLET

12
 CHAPTER-9
PACKAGING

Tablets must be packaged before they can be sent out for distribution. The type of packaging
depends on the formulation of the medicine.

Blister packs are acommon form of packaging. They are safe and easy to use, and the user can
see the contents without opening the pack. Many pharmaceutical companies use a standard size
of blister pack. This saves the cost of different tools and changing the production machinery
between products. Sometimes the pack may be perforated so that individual tablets can be

the package. The blister pack tself must remain absolutely flat as it travels through the
packaging processes, especially when it is inserted into a carton. Extra ribs are added to the
blister pack to improveits stiffhess,

Pharmaceuticalpackaging plays a number of important roles when shipping sensitive and

tightly regulated products, Not only must it protect the contents from physical damage, but
should ensure zero alteration is made to the chemical composition. Which is often achieved
through primary, secondary and tertiary packaging. With a wide range of pharmaceutical
products available on the market, both standard and bespoke packaging can be manufactured
to meet product demands.From temperature controlled solutions,to tamper evident tape and
customslabelling, even the most delicatemedicines can be shipped safely.

Here, we explore types of pharmaceutical packaging and the benefits they have for your

products.

Primary,secondaryand tertiary packaging

When breaking down the types of pharmaceutical packaging available, this can be done
through primary, secondary and tertiary packaging. We can then dive into these types further

and explore the products used within.

Primary pharmaceutical packaging: Whether it be a drug, medicine, or other formulation,

primary pharmaceutical packaging is used in direct contact with the product to protect its

chemical composition.
Let's take a look at some examples:

Vials -A glass or plastic container used to contain liquid, solid or a powder dosage form.
Ampoules- Similar to vials, ampoules are smaller glass containers (sometimes plastic)

used for packaging liquids.

• Blister packaging -A thermoformed plastic with cavities for tablets or capsules, sealed on
open skde win pste o a
nd the or cansule, each content is protected individually
tablet

for an increased shelf life. An alternative form of blister packaging.

The type ofprimary packaging used all depends on the fom and chemical composition of your
product. Capsules and tablets are often secured in blister and strip packages, while liquids are
usually placed in vials or ampoules.

Secondary pharmaceutical packaging: The main purpose of secondary packaging is for

brand awareness as well the display and handling of products. As an example, secondary
packaging would be the branded boxes used to display products in supermarkets.

13
Secondary packaging also plays a vital role in the distribution and protection of
pharmaceuticals. Think of it in this way, secondary packaging is used to protect the primary
packaging, which is protecting the product.A glass vial wouldn't last long if packed directly

into a shippng casel nd in the form ofbespoke

cartons. Not only are they casily

customizable, helping with brand awareness, but offer good protection and can be recyclable
too

The benefits ofsecondarypackaging

When tackled properly, secondary pharmaceutical packaging can have major benefits on your
business, these include:

.Building your brand

Inereasing sales

. Simplifying your shipping process

Reducing damaged

ys
Tertiary pharmaceutical packaging: Tertiary packaging comes into play with the need for

transportation.It's designed to absorb any physical impacts, as well as any moisture and dust

probiems ons od to nrotect both the product and

packaging that sits

beneath itduring transportation,This may include:

Cardboard boxes
Shrink film

Stretch wrap
Wooden and plastic pallets

The benefits of tertiary packaging

An optinmized tertiary packaging solution should look to combine products as tightly and
compact as possible, while using minimal materials and without causing strain or damage to
products. This helps to:

Increase pallet stability

Decrease C02 cmissions

Lower tiansport costs

waste
Proteet the nroduet
Contains manyunts of
secondary package
Contains many units of dosage fom. dlormer nackann
ctually goes in hand of paler

Dosage fom
00000
Primany package Secondary package Tertlary package

FIG, N0, 07
KIND OF PACKAGING

FIG.N0, 08 Blister Packs:

14
 FIG.NO,09 FIG.NO. 10

Bottle Packaging Ampoules Packaging

FIG.NO. I FIG.NO.12

Vials Packaging Sachet Packaging

15
 CHAPTER-10
Evaluation of Tablet:

General Appearance:The general appcarance of a tablet, its identity and general

elegance is essential for consumer acceptance, for control ofLot-tolot uniformity and

tablet-t0-tablet uniformity. The control of general appearance involves the

measurementofsize, shape, colour. presence or absence of odour, taste etc.
Size & Shape: It can be dimensionally deseribed & controlled. The thickness of a
tablet is only variable. Tablet thickness can be measured by mierometre or by other
device. Tablet thickness should be controlled within a5% variation of standard
Unique identification marking:These marking utilise some form of embossing,
ving or printing. These markings inchide company name or symbol, product
produet name ete

Organoleptic properties: Colour distribution must be uniform with no mottling. For

visual colour nparison compare the colour ofsampleagainst standard colour.
Hardnessand Friability: Tablet requires a certain amount of strength or hardness
and resistance to friability to withstand mechanical shakes of handling in

manufacture, packaging and shipping

Friability: Friability of a tablet can be determined in the laboratory by Roche. This
consists ofa plastic chamber that revolves at 25 rpm, dropping the tablets through a

Distance of sixinches in the, which then operates for 100 revolutions,The tablets are
reweighed, Compressed tablets that lose less than 0.5 to 1.0% oftheTablet weight

are considered acceptable.

Drug Content and Release:

Weight Variation test: Take 20 tablets and weigh them individually. Caleulate average
weight and compare the individual tablet weight to the average. The tablet passed the
U.S.P. test if no more than 2 tablets are outside the percentage limit and if no tablet
differs by more than 2 times the percentage
Content Uniformity Test: Randomly select 30 tablets, 10 of these were assayed
individually.The Tablet passes the test if9 of the10 tablets must contain not less than
85% of the labelled drug content and the 10th tablet may not contain less than 75% and
more than 125% of the labelledcontent. If these conditions are not met, remaining 20
tablets assayed individually and none may fall outside of the85 to I15% range.

Disintegration Test: The U.S.P. The device to test disintegration uses 6 glass tubes
that are 3" long open at the top and 10 mesh screens at the bottom end. To test for
disintegration time, one tablet is placed in cach tube and the basket rack is positioned
in a 1-L bcaker of water, simulated gastrie fluid or simulated intestinal fluid at 37+2 "C
such that the tablet remains 2.5 cm below the surface of liquid on their upward
movement and not closer than 2.5 cm from the bottom of the beaker in their downward

movement. Move the basket containing the tablets up and down through a. According
to the test the tablet must disintegrate and all particles must pass through the 10 mesh
sercen in the time specified. If any residue remains. It must have a soft mass, distance
of 5-6 cm at a frequeney of 28 to 32 eyelets per minute. Floating of the tablets can be
prevented by placing perforated plastic dishes on each tablet. Disintegration time:
Uncoated tablet: 5-30 minutes Coated tablet: 1-2 hours

6
 Dissolution Test:

Two set of apparatus:

o Apparatus-1: A single tablet is placed in a small wire mesh basket attached to the bottom
of the shaft connected to a variable speed motor. The basket is immersed in a dissolution
medium (as specified in the monograph)contained in a 100 ml flask. The flask is cylindrical
with a hemispherical bottom. The flask is maintained at 37-0.5°C by a constant temperature

bath The motor is adjusted to turn at the specified speed and samples of the fluid are
withdrawn at intervals to determine the amount ofdrug in solution.

Apparatus-2: It is the same as apparatus-l, except the basket is replaced by a paddle. The
dosage form is allowed to sink to the bottom of the fask before stirring. For dissolution

test U.S.P. specifies. the dissolution test medium and volume, type ofapparatus to be use,
rpm of the shaft, time limitof the test and assay procedure for. The test tolerance is
expressed asa %
of the labelled amountofdrug dissolved in the time limit.

17
 MY LEARNING AT LABORATE PHARMACEUTICALS
The
OngoE e
of industrial
overall objective of industra
vaili
n
anmmsebd
training

Bninot
is to involve student in practical
I
oone throueh
studies which
my industrial
are

pat
There I was emnloved at tablet p
production
nt ae a tinee where particularly production of different tablets taking place 1

my industrial o
performed training in the follow wing nrocedure

o At very first day my industrial training. observed that how raw material are kept and stored

I
I learned how cach raw material that used for formulating our dosage form must undergo

I
various quality chccks.

At next day of my training, we received our quality report of our raw material that taught
me how a drug is assayed before manufacturing to get assure about quality and maintaining
the standards,
At day three I carried out weighing of chemicals for the manufacturing and then we started

the procedure of manufacturing of havax fort tablet whose batch no, was 22hx07(b) having
batch size ofS lack tablets. All raw materials was dispensed according to batch formula.
* Next day sizing or grinding of all raw materials was carried out to ensures the uniformity
size of the excipient and active pharmaceutical drugs using fluid energy mill.

4 Then it is transferred to 'v' cone blender for successful mixing of excipientswith APis.
* Havax fort tableting is carried out by dry granulation using a roll compaction machine by
compacting primary particles into larger granules and formation of slug takes place.
Then proper residualmoisture level is maintained using fluidized-bed dryer.

* Next I preformed tableting process by using multi-station machine. It squeezed the

ingredients into the required tablet shape with extreme precision

* It is a continuous process until the required quantity of tablets are produced. also

I
preformed qualityassurance parameter tocheck the plhysical parameter of the tablets which
are record in the following pages
* Then after the production quality control department carried out various quality parameter
and issues the report of the quality levels

Then after the report sugar coating of tablet is carricd out in pan coating machine.
* After that dried tablets are processed for packaging mostly blister packs are used for

packing materials and the required information are also printed on

it.
Than our worthy chemist sir has taught us how samplewas to be checked and finally the
product left for storage area.

* At last want to tell you

I that learned that industrial training has provide me a great

knowledgeand how many effort and knowledgeare to be used to prepare a good and a

safer pharmaceutical produet.

18
 LAIORATE PHARMACEUTICALUNDIA)
OMCON BRAWIMENT
I'RODU

FOR TALT
Name of ChomisRonak AhaN oCESs Date.

Ploct Namd Havaxahlat Sath Na .22H x3()

l20i2 Exo,Lhale. NouRo2......
Sizet.5 loc Mi Date.... Nov

Deiyk Rond yalOru.om sa scad..othan side aymad HAVAKfoRT

WL. of 20tablets: 7332 ..(in gm) Averge wt. tablet; 3664.in mel

of
4o7400 34 346388389
318 392 390402 400 2 4o6 391 39sYo2.

WI. Variation Limit ()3243g (o.3Y27 mp Wage Deviation froun avg. wt. (4):35.%(-o3%)

Disintegrakon Tine Minute Iriability: 1wiw

asaeN.te,NMT

Ilandaessi..D8.....sekglem

Remark:

) Timc:32

Decfpie.Roumd
PM
/yelenol one side sconad atan side augad nAVAx fokre
WI. of 20 tahlets:.73.87...(lngm) Average wt. of tablet: 37?3S.(inmp)

398 392 390 39syo1

381YS 386 396 340 Mi5 412 41Yos400
WL Variation Limit ()Mmg(-33mgage Deviation from avg, wt. ():30.%(3:2.9)

Disintegation Time: .9 awud nit 1S.Miute Friability:. NMI 1%ww

Itardness:.0.1...g/em

Remurks.

Production Chesist Production Manager

19
 CONCLUSION
Through this Industrial Training I gained lots ofknowledgeabout the Pharmaceutical Industry
and its inevitable role in society.

This one month helps me to understand the provisions to manufacture the sterile solid dosage
preparations, like tablets and its analysis and all about the production to a certain extent within
thisshort period.

Also helps me to understand the GMP requirements that should be complied by the

pharmaceutical Industry and its significance for the maintenance ofquality ofthe formulations.

These 31 daysgave me lots offield work experiences in the Industry.

22
 Reference
Mehta R.M. Pharmaceutics 2nd edition Vallabh Prakashan, Page no:-246252

Lachman, L., Licberman, H. A., and Kanig. J. L. (1986). The Theory

and Practice ofIndustrial Pharmacy, 3rd ed., Philadelphia: Lea & Febiger.
Allen L. V and Ansel H. C. (2014). Ansel's Pharmaceutical
Dosage Forms and Drug Delivery Systems. Philadelphia: Lipincott Williams
and Wilkins.
Dash, A. (2014), Solid Dosage Forms, In A. Dash, S. Singh and J.

Tolman (Eds). Pharmaceutics: Basic Principles and Application to Pharnacy.

(pp.161-180), USA: Elsevier Inc

GendreC., Genty M., César da Silva J., Tfayli A., Boiret M., Lecoq O.,
Baron M. Chaminade P., Péan J-M., Comprehensive study of dynamiccuring
effect on tablet coating structure, Eur. J. Pharn. Biopharm., 81 (2012), 657-665

ugar Confectionery Manufacture (1999) by E. B. Jackson, chapter I.

I
Hans-Jürgen Bässler und Frank Lehmann : Containment Technology:
Progress in the Pharmaceutical and Food Processing Industry. Springer, Berlin
2013,ISBN 978-3642392917

23