Production Department

Assigned person,
Md. Hafizur Rahman (Senior Deputy Manager, Production)
Md. Zahidul Islam Khan (Senior Assistant Manager, Production)
Md. Jobaer Alam (Assistant Manager, Production)
Tablet Processing Unit

Solid Section:
Solid dosage forms are among the most inexpensive, popular, and convenient methods of
drug delivery. They can be manufactured in a non-sterile environment, and the technology is
wellknown after over a century of development. Because most pharmaceuticals are
manufactured in solid dosage forms, it is critical that the unit operations for their production
be thoroughly understood. This course covers the fundamentals of each discrete processing
step (unit operation) needed for the production and packaging of tablets and capsules, the
most common solid dosage forms.

Manufacturing Area

Tablet
A tablet is a solid formed by pressing or compacting active substances and excipients, which
are typically in powder form. Binders, glidants (flow aids), and lubricants are used to ensure
efficient tableting; disintegrants are used to break up the tablet in the digestive tract;
sweeteners or flavours are used to mask the taste of bad-tasting active ingredients; and
pigments are used to make uncoated tablets visually appealing. A polymer coating is typically
applied to hide the taste of the tablet's components, make the tablet smoother and easier to
swallow, and increase its resistance to the environment, thereby extending its shelf life.

1
A Typical Tablet Contains

Tablet Excipients:
Anti-adherents:
Anti-adherents are used to reduce the adhesion between the powder (granules) and the punch
faces and thus prevent sticking to tablet punches. The most commonly used is magnesium
stearate.

Binders:
Binders hold the ingredients in a tablet together.
Binders allow tablets and granules to be formed with the necessary mechanical strength while
also providing volume to low active doses tablets. Starches, sugars, cellulose or modified
cellulose (such as microcrystalline cellulose, hydroxypropyl cellulose), lactose, or sugar
alcohols such as xylitol, sorbitol, or maltitol are common binder materials.

Disintegrants:
Disintegrants expand and dissolve when wet causing the tablet to break apart in the digestive
tract, releasing the active ingredients for absorption. Disintegrant types include:
1. Water uptake facilitators
2. Tablet rupture promoters
They ensure that when the tablet is in contact with water, it rapidly breaks down into smaller
fragments, thereby facilitating dissolution. Examples of disintegrants include: crosslinked
polyvinyl, sodium starch glycolate, crosslinkedcrosslinked sodium (crosscarmellose).

Fillers and diluents:

Fillers fill out the size of a tablet or capsule, making it practical to produce and convenient for
the consumer to use. By increasing the bulk volume, the fillers make it possible for the final
product to have the proper volume for patient handling.
Plant cellulose (pure plant filler) is popular filler in tablets or hard gelatin capsules. Dibasic
calcium phosphate is popular tablet filler. A range of vegetable fats and oils can be used in
soft gelatin capsules.
Other examples of fillers include: lactose, sucrose, glucose, mannitol, sorbitol, calcium carbonate,
and magnesium stearate.

Flavours:
2
Flavours can be used to mask unpleasant tasting active ingredients and improve the likelihood
that the patient will complete a course of medication. Flavourings may be natural (e.g. fruit
extract) or artificial.

Colours:
Colours are added to improve the appearance of a formulation. Colour consistency is
important as it allows easy identification of a medication.

Glidants:
Glidants are used to promote powder flow by reducing interparticle friction and cohesion.
These are used in combination with lubricants as they have no ability to reduce die wall
friction. Examples include colloidal silicon dioxide, talc, and magnesium carbonate.

Lubricants:
Lubricants prevent ingredients from clumping together and from sticking to the tablet
punches or capsule filling machine. Lubricants also ensure that tablet formation and ejection
can occur with low friction between the solid and die wall.
Common minerals like talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or
stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules.

Sweeteners:
Sweeteners are added to make the ingredients more palatable, especially in chewable tablets
such as antacid or liquids like cough syrup. Therefore, tooth decay is sometimes associated
with cough syrup abuse. Sugar can be used to disguise unpleasant tastes or smells.

Tablet Production
In tablet production there are several steps involved which are following:
➢ Dispensing
➢ Weighing and dry mixing
➢ Wet mixing
➢ Dry mixing
➢ Final drying
➢ Lubrication
➢ Coating (if needed)
➢ Compression
➢ Secondary packaging

Granulation Unit
Granulation is a mechanical process used to change the physical properties of a powder or
powder blend. Flow characteristics, density, and particle size are the primary parameters
influenced by this [Link] processes are employed when the raw material powder
or blend exhibits behavior properties that hinder other manufacturing processes. All the
materials are received from the dispensing unit and granulation is performed. For suitable
granulation, it is required to have 30-40% powder and 60-70% granules and also 1-5%
moisture in compressing particles.

Purposes Of Granulation
3
 1. To produce tablets of appropriate size.
2. To prevent segregation of the constituents in the powder mix.
3. To improve the flow properties of the powder mix.
4. To improve compression nature of powder.

Types of granules

Two types of granules are produced in the four-granulation units of the industry, which
include; • Granules with active ingredient/s
• Placebo granules without any active ingredient/s for moisture sensitive active/s or
drug/s

There are three types of granulation process. Such as- 1.

Wet Granulation.
2. Dry Granulation.
3. Direct compression

Wet granulation:
Wet granulation is a process of using a liquid binder or adhesive to the powder mixture. The
amount of liquid can be properly managed, and over wetting will cause the granules to be too
hard and under wetting will cause them to be too soft and friable. Aqueous solutions have the
advantage of being safer to deal with than solvents.

Flow Chart of Wet Granulation:

Weighing of active ingredient as well as excipients
↓
Dry mixing
↓
Paste mixing by addition of de-mineralized (DM) water or Maize starch paste in Rapid Mixer
Granulator (RMG) for a certain time period specified in the Batch Manufacturing Record
(BMR)
↓
Initial Phase drying in Fluid Bed Dryer (FBD)
↓
Milling in the Multi-mill
↓
Partial drying in FBD
↓
Milling in the Multi-mill
↓
Terminal/Final drying in the FBD
↓
Sieving in the Vibratory Sifter according to the required particle/granule size
↓
Measurement of Loss on Drying (LOD)

4
 ↓
Granules of desired size ready for blending with lubricants

Dry granulation
Dry granulation is the process of forming particles—i.e., granulates or granules—from dry
powder or powder blend without adding liquid to aid in the process. It serves as an
established manufacturing process in the chemical, life science, and pharmaceutical
industries, playing a key role in preparing powdered material for further processing.
Dry granulation equipment offers a wide range of pressure and roll types to attain proper
densification. However, the process may require repeated compaction steps to attain the
proper granule end point.

Flow Chart of Dry Granulation

Weighing and sieving of drugs and excipients

Dry mixing of API and diluents

Slugging or pre-compression

Milling and sieving

Lubrication

Discharge for compression

Direct compression
Direct compression is a standard and widespread approach of tableting in pharma industries
as it is rapid and proficient without having significant production expenses. Direct
compression is an efficient method of manufacturing tablets that requires fewest production
steps. Apart from process simplicity this method has reduced capital, energy cost and
excellent for treating water sensitive active ingredients. This method is used when a group of
ingredients can be blended and placed in a tablet press to make a tablet without any of the
ingredients having to be changed.
Weighing of drugs and excipients
↓
Mixing of all ingredients
5
 ↓
Sieving
Discharge for compression

Machineries Used During Granulation

New Machine

NO. NAME OF MACHINARY COMPANY NAME

1. RAPID MIXER GRANULATOR EAST, MUMBAI
3. FLUID BED DRIER SHIMADZU, JAPAN
4. WET GRANULATOR YENCHEN MACHINERY [Link],TAIWAN
5. SIFTER YENCHEN MACHINERY [Link],TAIWAN
6. V-CONE BLENDER YENCHEN MACHINERY [Link],TAIWAN

Tablet Compression

Tablets are made by compressing a formulation containing a drug or drugs with excipients on
stamping machines called Tablet Presses or Tablet compression machine.

Tablet Compression is a manufacturing process used to convert powdered or granulated

pharmaceutical ingredients into tablets of a specific shape, size, and weight. This process
involves compressing the ingredients into a solid dose form using a Tablet Compression
machine.
It is a critical step in the production of solid oral dosage forms, as it ensures that the active
ingredients are uniformly distributed throughout the tablet and that the tablet has the required
physical characteristics, such as hardness, disintegration time, and dissolution rate.
6
The main aim of design and manufacture of compressed tablet is to deliver orally the correct
amount of drug in the proper form at or over the proper time and in desired location and to
have its chemical protected to that point.

Flow Chart of Tablet Compression

Granules (previously made)

↓
Transfer of granules in the Hooper of tablet press machine
by hand or auto powder/granules loader
↓
Rising of upper punch & dropping of lower punch
↓
Filling of die cavity through feed frame
↓
Removal of extra granules by scrape off plate
↓
Coming down of upper punch for
↓
Compression to produce tablet
↓
Raising of both upper & lower punches to certain extent
↓
Ejection of tablet with the help of take out plate
↓
Conventional Uncoated Tablets
of desired shape and size

Common Problems that generally arise during compression are -

1. Capping
2. Chipping
3. Sticking
4. Weight variation
5. Mottling
6. Hardness problem
7. Lamination

Tablet Coating

7
Coated tablets are tablets that have one or more layers of a mixture of various substances,
such as natural or synthetic resins, gums, gelatin, inactive and insoluble fillers, sugars,
plasticizers, polyols, waxes, coloring matter approved by the competent authority, and, in
some cases, flavoring and active substances. Coating substances are typically applied as a
solution or suspension in conditions that allow the vehicle to evaporate. Film-coated tablets
are those that have a very thin polymeric coating applied.
Coated tablets have a smooth surface that is often colored and polished. A broken section,
when examined under a lens, reveals a core surrounded by one or more continuous layers of a
different texture.

Objectives of Tablet Coating

1. To protect against deterioration by environmental factors like sunlight, temperature

variations, moisture, environmental gases etc
2. To facilitate swallowing.
3. To mask taste and odor
4. To increase shelf-life.
5. To enhance aesthetic appeal and brand image.
6. To facilitate product identification during manufacture and prevent wastage during packing
and handling
7. To provide immediate release, specific release, sustained release, controlled release and
targeted drug delivery properties.
8. To provide enteric release properties for release in the intestinal tract. 9. To facilitate
identification of oncological drugs

Classification of Coating:
Mainly three types of coating are performed in the solid section. They are as follows:
1) Sugar coating
2) Enteric coating
3) Film coating

Film Coating:
A film coating is a thin polymer-based coat that is typically
sprayed onto solid pharmaceutical dosage forms, such as tablets, capsules, pellets or

8
granules. Film coating can impact both its appearance and its pharmacokinetics making it an
essential process in making the final drug product.
Film coatings are the most common form of drug coating and are generally applied in orally
administered pharmaceuticals. The motivation for applying film coatings to dosage forms
range from cosmetic considerations (color, gloss and branding), improving the shelf life by
providing a protective barrier between the drug and the surrounding environment, and making
the dosage form easier to swallow. These types of film coatings are known as non-functional
film coatings. They may also be used to delay or augment the delivery and uptake of
medications or delay release and uptake until the medication passes through the stomach.
These types of film coatings are known as functional film coatings.

Process Principles:
A very even application of the coating material is an important feature of the coating process.
Coatings must be dense and without mechanical damage and cracks. Film coating is an
effective process for the application of protective films for manipulating the product
characteristics. Glatt offers various technical solutions for coating different particles and
tablets:

1. Fluid Bed Coating (Top Spray Coating, Bottom Spray Coating, Rotor Coating)
2. Drum Coating
3. Spouted Bed Technology
4. In each case, the coating fluid is sprayed onto the solid material, which is presented to it.
The introduction of the process air evaporates the fluid and dries the film coating.
Small droplets and a low viscosity ensure a uniform distribution.

Enteric Coating:
An oral dosage form in which a tablet is coated with a material to prevent or minimize
dissolution in the stomach but allow dissolution in the small intestine. This type of
formulation either protects the stomach from a potentially irritating drug (e.g., aspirin) or
protects the drug (e.g., erythromycin) from partial degradation in the acidic environment of
the stomach erythromycin) from partial degradation in the acidic environment of the stomach.

9
Instruments / Apparatus Used in Tablet Coating
There are various types of sophisticated instruments are used for the purpose of tablet coating.
The instruments are:
➢ Coating Machine (FD&C Equipment [Link].), Karachi

Coating Procedure
1. Preparation of coating suspension:
Take purified water in a vessel.
↓
Add the ready coating materials carefully to the region of vortex
↓
Stir the dispersion for 45 minutes.
↓
Filter through 60 mesh size(if necessary)
↓
Add extra purified water for good dispersion (if necessary)

2. Coating process:
Coating suspension (Aqueous)
↓
Tablets into coating pan
↓
Warm up the core tablets for 10 minutes at 35-40°C
↓
Set the required inlet (60-70°C) and outlet(45-55°C) temperature.
↓
Start the coating pan
↓
Set the RPM of coating pan within 2-3
↓
Set the RPM of peristaltic pump within 8-12
↓

Set the atomizing air pressure within 3.5-4 kg/cm²

↓
Continue to spray by spray gun until all dispersion has been used
↓
Stop spraying after coating is completed
↓
Rotate the pan for 10 minutes to remove any solvent.
↓
Stop the blower, exhaust and heater and allow cooling.

Important critical parameters to check prior to spray coating solution

10
 • Pump speed
• Pan Rotation
• Bed Distance
• Negative Pressure
• Inlet Air Temperature
• Outlet Air Temperature
• Atomizing Air Pressure
• Fluid Return Volume
• Nozzle Distance from the Tablet Bed.

COMMON PROBLEMS ASSOCIATED WITH TABLET COATING:

Logo Bridging

Cause:
1. Surface characteristics of the product being coated
2. Inadequate adhesion of film coating
3. Inadequate design of logo (e.g. too detail/fine logo)
Remedy:
1. Modify core formulation to include more hydrophilic ingredients
2. Increase core porosity
3. Using formulation with increased adhesion property.
4. Increase area within the debossing and modified angles.
Core Erosion

Cause:
1. Inherent softness or high friability of core.
2. Excessive pan speed in coating process.
3. Spray rate too low.
4. High sensitivity of core to moisture as coating is applied.

Remedy:
1. Increase mechanical strength of core.
2. Decrease pan speed.
3. Increase spray rate.

11
Edge chipping/erosion:

Cause:
1. Low mechanical strength of coating
2. Excessive pan speed
3. Low solid content in coating liquid
4. Low spray rate
5. Sharp edges on tablets
6. Worn tablet punches

Remedy:
1. Using formulation with increased mechanical strength
2. Decreased pan speed
3. Increase solid content in coating liquid
4. Decrease spray rate
5. Use modified punch design

Picking/sticking:

Cause:
1. Spray rate too high
2. Inadequate drying condition
3. Pan speed too low
4. Inadequate atomization of coating liquid
5. Poor distribution of coating liquid

Remedy:
1. Decrease spray rate
2. Increase drying condition
3. Increase pan speed
4. Increase atomizing air pressure/volume

Cracking:
12
Cause:
1. Low mechanical strength of coating, exacerbated by inadequate plasticization,
excessive pigmentation.
2. Core has significantly different thermal expansion characteristics than coating.
3. Extended strain relaxation of core after compaction.

Remedy:
1. Selecting formulation with increased mechanical strength and elasticity
properties.
2. Avoid use of mineral type fillers (e.g. CaCO3, CaSO4, MgCO3 etc.)
3. Extend holding period of tablets prior to submitting them to coating process.

Peeling:

Cause:
1. Low mechanical strength of coating
2. Poor adhesion of coating to tablet surface

Remedy:
1. Using ingredients of improved mechanical strength.
2. Using ingredients with improved adhesion properties.

Orange peel/roughness:

Cause:
1. Viscosity of coating liquid is too high
2. Poor atomization of coating liquid
3. Excessive drying condition
4. Over wetting (causing coating too rub)

Remedy:

13
 1. Decrease solid content of coating liquid
2. Increase atomizing air pressure/volume
3. Decrease inlet air temperature/flow rate
4. Decrease spray rate Twinning:

Cause:
1. Spray rate too high
2. Pan speed too low
3. Inappropriate tablet shape

Remedy:
1. Decrease spray rate
2. Increase atomizing efficiency
3. Increase pan speed
4. Select new tablet shape that decrease chances of flat surfaces coming into contact
during application of coating liquid. (e.g. avoid capsule shape tablet with thick side
wall)

Tablet-to-tablet color variation

Cause:
1. Too little coating applied
2. Inadequate mixing of tablet during coating
3. Poor opacity (or hiding power)
4. Solid content of coating liquid too high
5. Insufficient number of spray gun

Remedy:
1. Increase quantity of coating applied
2. Increase pan speed/increase improve baffle system
3. Reformulate coating with respect to colored ingredients or use an opacified white
precoat.
4. Decrease solid contents of coating liquid.
5. Increase number of spray gun.
Catering
It is defect of film coating whereby volcanic-like craters appears exposing the tablet surface.

Reason:
14
The coating solution penetrates the surface of the tablet, often at the crown where the surface
is more porous, causing localized disintegration of the core and disruption of the coating.

The Cause & Remedies of Cratering:

Sr. CAUSES REMEDIES

No.
1. Inefficient drying. Use efficient and optimum drying conditions.
2. Higher rate of application of Increase viscosity of coating solution to
coating solution. decrease spray application rate.

Pitting
It is defecting whereby pits occur in the surface of a tablet core without any visible disruption
of the film coating.

Reason
Temperature of the tablet core is greater than the melting point of the materials used in the
tablet formulation.

The Cause & Remedies of Pitting:

Sr. CAUSE REMEDY

No.
1. Inappropriate drying (inlet air ) Dispensing with preheating procedures at the
temperature initiation of coating and modifying the drying
(inlet air) temperature such that the temperature
of the tablet core is not greater than the melting
point of the batch of additives used.

Blooming
It is defect where coating becomes dull immediately or after prolonged storage at high
temperatures.

Reason:
It is due to collection on the surface of low molecular weight ingredients included in the
coating formulation. In most circumstances the ingredient will be plasticizer.

The Cause & Remedies of Blooming:

Sr. CAUSE REMEDY

15
 No.
High concentration and low
Decrease plasticizer concentration and increase
1. molecular weight of plasticizer.
molecular weight of plasticizer.

Blushing
It is defect best described as whitish specks or haziness in the film.

Reason:
It is thought to be due to precipitated polymer exacerbated by the use of high coating
temperature at or above the thermal gelation temperature of the polymers.

The Cause & Remedies of Blushing:

Sl. No. CAUSES REMEDIES

1. High coating temperature Decrease the drying air
temperature
2. Use of sorbitol in formulation which causes Avoid use of sorbitol with
largest fall in the thermal gelation Hydroxy Propyl Cellulose,
temperature of the Hydroxy Propyl Hydroxy Propyl Methyl Cellulose,
Cellulose, Hydroxy Propyl Methyl Methyl Cellulose and Cellulose
Cellulose, Methyl Cellulose and Cellulose ethers.
ethers.

Infilling
It is defect that renders the intagliations indistinctness.

Reason:
Inability of foam, formed by air spraying of a polymer solution, to break. The foam droplets on the
surface of the tablet breakdown readily due to attrition but the intagliations form a protected area
allowing the foam to accumulate and “set”. Once the foam has accumulated to a level approaching
the outer contour of the tablet surface, normal attrition can occur allowing the structure to be
covered with a continuous film.

The Cause & Remedies of Infilling:

Sl. CAUSE REMEDY

No.
1. Bubble or foam formation because of air Add alcohol or use spray nozzle
spraying of a polymer solution capable of finer atomization.

Orange peel/Roughness
It is surface defect resulting in the film being rough and nonglossy. Appearance is similar to
that of an orange.

16
Reason:
Inadequate spreading of the coating solution before drying.

The Causes & Remedies of Orange Peel/ Roughness:

Sl. No. CAUSES REMEDIES

1. Rapid Drying Use mild drying conditions
2. High solution Use additional solvents to decrease viscosity of
viscosity solution.

The above problems can be overcome by following solutions:

• Select suitable coating material.
• Change spray rate.
• Change drying rate.
• Change distance between spray guns and surface of tablet bed.
• Change atomizing air pressure.
• Change inlet air temperature/air flow.

During our training we have observed the manufacturing of the following tablets:
• ESOCON MUPS
• R-Pil
•
In process quality control (IPC) of Tablet:
The in process control is made during the course of manufacture of tablet which aims to
ensure that products will comply with specification. Thus, quality is built into the product in
BIOPHARMA Limited; the following parameters are performed for in process checks:

Process In-process checks

Dispensing Weighing & recording
Mixing Time & Speed
Granulation Uniformity of content, time and speed
Drying Temperature (inlet & outlet) pressure, moisture content
Lubrication Uniformity of content
Compression Machine speed, Compression process, thickness, hardness,
friability, appearance, avg. and uniformity of weight, DT
of tablets
Coating Temperature, moisture, speed, time uniformity,
appearance, DT
Tablet Packaging

17
Tablet Packaging Section:
There are two different types of Packaging Configuration are used in Biopharma Ltd.
A. Blister Package
The blister package is formed by heat softening sheet of thermo plastic resin and vacuum
drawing the softened sheet of plastic into a contourd mold, Aluminum foil and PVC
blister are used in this packaging.
B. Strip Package
A strip package is formed by feeding two webs of a heat-sealable flexible film through either
a heated crimping roller or a reciprocating platen. Aluminum foils are used in this
packaging.
Following Packaging Machines are used in BPL

Blister machine-1
Company : Hoonga-A corporation
Source : Korea
Blister machine-2 (Automatic)
Company : Hoonga-A corporation
Source : Korea

We observed during Packaging:

• ACETA Tablet-500 mg.
• Cipcin 500mg
• Perilac 10mg

Cream & Ointment Unit

18
Cream & Ointment:

A cream is a topical preparation usually for application to the skin. Creams for application to
mucus membranes such as those of the rectum or vagina are also used. Creams may be
considered pharmaceutical products as even cosmetic creams are based on techniques
developed by pharmacy and unmedicated creams are highly used in a variety of skin
conditions (dermatoses).Creams are semi-solid emulsions, that is mixtures of oil and water.
They are divided into two types: oil-in-water (O/W) creams which are composed of small
droplets of oil dispersed in a continuous aqueous phase, and water-in-oil (W/O) creams which
are composed of small droplets of water dispersed in a continuous oily phase. Savlon A/C
cream manufacturing process are given below.
Materials Used:

1. Strong cetrimide BP
2. Chlorohexidine HCL BP
3. Cetostearyl alcohol BP
4. Liquid paraffin BP
5. Antiseptic perfume [Link]
6. Purified water

Machinaries Used in Cream Filling & Sealing:

Machine Name Specification and Origin

19
 Automatic tube filling machine and sealing ZHE JIANG HUALIAN Pharma machinery
machine [Link], CHINA.
Automatic tube filling machine MAHARSHI Liquid filling machine, INDIA.

Positive liquid filling machine Bangladesh

Vacuum emulsification mixer TIANFU MACHINE,CHINA.

Automatic labeling machine
HUNAN CHINASUN Pharmaceutical co.
ltd, CHINA.

Round over pilfer proof sealing machine Bangladesh

(R.O.P.P cap sealing machine)

Dry Syrup & Capsule Processing Unit

Dry syrup Dry

Syrup Section
Dry syrup is the preparation that is formulated as dry powder but administered orally as liquid
dosage form. They are prone to hydrolysis during extended exposure of moisture. They are to
be reformulated by mixing with certain amount of boiled water and should be use up within
certain periods (5 days at normal temperature).

Physical plant design:

It is divided into two areas-

1. Manufacturing area 2. Filling and sealing area.

Excipients used in dry syrup:

20
 1. Sugar: Sweetening agent.
2. Colloidal silicon dioxide: Increase flow property.
3. Na-citrate/citric acid: Buffering agent.
4. Methyl paraben: preservative.
5. Color: FDC grade (Lemon, orange)
6. Flavor Raspberry, orange.
7. Na-CMC: Only for Cefidoxim as a suspending agent.

Precaution:
Temperature should be within 20-250C

Relative temperature should be within 30-35%

We observed the manufacturing of following Dry syrup preparation:

• Biopen-VK DRY Syrup.
• Lactu syrup

Steps of Dry Syrup Preparation:

1. Weighing
2. Mixing
3. Sieving
4. Cone blending
5. Mixing
6. Finished product

Machineries used for dry syrup preparation

Name of the machine: Riggs Autopade

Origin: England
Model: BB9OLD.

Other Machines are:

Mars Mechanicals Source: India
Mark Bottle Sealing Machine Source: Bangladesh
Kothari (Sugar Crushing Machine). Source: India.
Multimilling Machine Source: Bangladesh Blender
Machine (400 Kg).

21
 Capsule

Capsule Section
Capsules are the solid unit dosage form of medicament in which the drug(s) is enclosed in a
practically tasteless, hard or soft soluble container or shell made up of a suitable form of
gelatin. Gelatin shells are supplied in a number of sizes. The number varies from
000 to 5, the former being the largest and later the smallest. The exact amount of a
medicament which can be filled in a particular size of capsule shell depends upon density of
the material to be filled in. Generally the capacity varies from 600mg to 30mg.

Advantages
• Capsules are tasteless, odorless and can be easily administered.
• Attractive in appearance.
• The drugs having unpleasant odor and taste are enclosed in a tasteless shell.
• They can be filled quickly and conveniently therefore the physician can change the
dose and combination of drugs to suit the individual patient. This is an advantage over
tablets.
• Flexibility in onset and duration of action also contribute to the suitability of the
capsule as a pharmaceutical dosage form.
• Ease of formulation.
• Limited potential for incompatibilities.
• Good stability.
• Easy to swallow.
• They are economical.
• They are easy to handle and carry.

Disadvantages
• Capsules are not usually used for the administration of extremely soluble materials
such as potassium chloride or ammonium chloride.
• Capsules should not be used for highly effervescent or deliquescent materials.
Effervescent materials may cause the capsule to soften.
• Deliquescent powders may dry the capsule shell to excessive brittleness.
• The concentrated solutions which require previous dilution are unsuitable for capsules
because if administered as such lead to irritation in the stomach.

Process of capsule filling:

22
 • Manual- This type of filling process is used to fill powder materials or the materials
which have poor flow property.
• Auto- Mainly pellets which have good flow property are used to fill by this process.

Procedure of Manual Capsule Filling:

Capsule shells are set into the plate through insetter
↓
Plate set into the hand filler
↓
Body and cap separated by scissor
↓
Fill the body with materials
↓
Attached body and cap
↓
Capsules

Machines Are Used:

• Auto-Capsule machine:
Name of company: Fuchang Machinery Company limited.
Model: NJP-800 series fully automatic hard capsule filling machine.
Origin: China.
Minimum output per minute: 600 pc’s capsule.
Maximum output per minute: 800 pc’s capsule.

• Semi Auto-Capsule machine:

In this machine the capsule pouring system is automatic, but the system of filling
(powder, pellets) or locking is manual.

Name of the company: Pharmaceutical and allied machinery company privet limited.

Model: SR NO: SA/25/21

Origin: India.

Fig. Hand Operated Capsule Filling Machine

23
Procedure of automatic Capsule Filling

Capsule shells into the hopper

↓
Meggine
↓
Cap boos and body boos
↓
Filling materials from chemical hopper
↓
Checking
↓
Close the body and cap by closing pin
↓
Capsule open from the boos by capsule open pin
↓
Capsules

Liquid Processing Unit

Liquid

The oral use of liquid pharmaceuticals has generally been justified by the ease of
administration to those who have difficulty swallowing solid dosage forms. A drug
administered in solution is immediately available for absorption and, in most cases, is
absorbed more quickly and efficiently than the same amount administered in tablet or capsule
form.

Advantages of Liquid Dosage Form

1. They are homogenous; there the medicament is uniformly distributed throughout the
liquid.
2. The doses can be easily adjusted according to the need of the patient.
24
3. They can be easily measured with the household measured.
4. They are more quickly effective than tablets or capsule because they are already in the
solution form and absorption starts quickly.
5. They can be easily colored, flavored or sweetened.
6. Children or patient who cannot swallow tablets or capsule can easily ingest solutions.

Disadvantages of Liquid Dosage Form

1. They are difficult to carry and there are chances of breakage of container with the complete
loss of contents.
2. In some medicaments their unpleasant taste and flavor is difficult to mask.
3. They are less stable as compared to solid dosage form because deterioration is faster in
solutions.

Units of Liquid Section

1. Processing Unit
2. Filling & Packaging Unit.

Processing Unit
In processing unit liquid dosage form of medicaments are prepared in appropriate vat.
Following steps are followed during manufacturing of liquid dosage form- 1.
Requisition of raw materials.
2. Collection and rechecking of weighed raw materials.
3. Compounding.
4. Bottle washing and drying.
5. Sending the sample of prepared formulation to the QC department for further
working information about the prepared formulation. If QC passed the sample
as a quality product then the process of filling & Packaging is started.

In Liquid Processing Unit Two Types Of Liquid Dosage Form Are

Manufactured. These Are-
1. Syrup

[Link]

25
Production of Syrup:

Manufacturing Vessel
(Tanner stainless steel
Fabricating vessel)

Homogenizer

Filtration

Storage vessel

Bottle filling

Sealing

Labeling

Packaging

Production of Suspension:

Mixing active ingredient & excipients in manufacturing Vessel

(Tanner stainless steel fabricating vessel)

Homogenizer

Particle size reduction by colloidal mill

Stirring

Storage vessel

Bottle filling
26
 Sealing

Labeling

Packaging

During our training period, we have observed manufacturing of

♦ LACTU syrup

Machineries Used in Processing Unit

2. Automatic filling Machine
3. Capacity :40 tubes/min.
4. Planetary Mixer.
5. Colloid Mill.
6. Steam jacket tank.
7. Laminar air flow unit.
8. Nitrogen gas line.
9. Compressed air line.
7. Holding tank.
8. Jabsco Pump.
9. UV Light.
10.
In-process quality control of Oral Liquid Dosage form:
In BIOPHARMA Limited the following parameters are performed for in process checks-
Process In-process checks
Dispensing Weighing and recording
Mixing Time and speed, uniformity of mixing
Filling pH, Uniformity of content, Viscosity, appearance, self life etc.
Filling and Packaging Unit:
After getting the permission to fill the prepared liquid product filling process begin. For
filling liquid into bottle in BIOPHARMA Limited, Volumetric method of filling is used.

Process of Liquid Filling

Transfer of Prepared liquid preparation into the filling machine from the processing
vat by the use of transfer pump.

Set the machine according to filling volume

Filling of bottles

27
 Sealing of bottle using sealing machine

Labeling and Packaging of

bottle

In Process Check during Filling & Packaging

Process In-process check

Filling pH, Uniformity of content, Viscosity, appearance, self life, volume of
filling etc.
Packaging Sealing, Exp date, MRP, Batch no and other information on the packaging
material etc.

Machineries Used in Filling & Packaging Unit

♦ Liquid Filling Machine (Capacity: 30-40 Bottle/Minute).
♦ Liquid Sealing Machine

28