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SEMINAR ONPreparation of Qualitative and

Quantitative Departmental layout with Equipments Required for

Solids dosage form

PREPARED BYMATHOLIYA CHETAN1ST SEM. M.PHARM

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LIST OF THE FORMLATION OF DOSAGE FORM ……

FOR SOLIDTABLETSCAPSULES

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TABLET

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INTRODUCTION

DEFINITION:- These are solid dosage forms each containing a

unit dose of one or more medicaments.

ADVANTAGES: - Unit dosage form with greatest dose precision &

least content variability among all oral dosage forms .

Cost is lowest among all oral dosage forms. Lightest & most compact of all oral dosage forms. Easiest & cheapest to pack & ship among all oral

dosage form. Tamperproof.

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May provide greatest ease of swallowing with least tendency for hang up above the stomach.

Better suited for large scale production

DISADVANTAGES:Drug having amorphous nature & low density

drug can not compressed into tablets.Drugs with poor wetting properties cant be

formulated to make as tablet.Bitter tasting drugs, drugs with an objectionable

odor, drug sensitive to oxygen coating may be required.

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QUALITATIVE LAYOUT WITH CIRCULAR FLOW

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CIRCULAR LAYOUT

Materials are weighed into batch quantities in dispensing & then moved into the manufacturing area. After completion of manufacturing the finished tablets are placed in quarantine & moved to bulk stock upon release .when packaging run is scheduled tablets, packaging components, are delivered from the bulk stock & approved storage area.

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LAYOUT WITH CROSS OVER TRAFFIC

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LAYOUT WITH PARALLEL FLOW

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ENVIRONMENTAL REQUIREMENT:

NAME OF AREA PRESSURE

MAINTAINED

WARE HOUSE 10 PASCAL

WEIGHING AREA 20 PASCAL

TABLETTING AREA 15 PASCALS

CENTRAL CORRIDOR 30 PASCALS

Temperature 25±50CHumidity 55 ± 10 % RH

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Humidity should be lowered for specific products like Effervescent tablets & moisture sensitive drugs.

Pressure within areas like mixing & tabletting area should remain on negative side than central corridor

Temp control & Air control should be such that there should be comfortable working environment. & no impact on characteristics of in process materials such as granulations, raw materials.

All areas should be properly ventilated with the use of roof fan.

 

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EXAMPLE:-

Suppose a batch of 1,00,000 tablet is to be prepared then each tab weighing 600mg then total powder material to be taken will be 60kg.

 Equipments used will be of following capacity: Planetary mixer – 100kg Fluidised bed dryer – 60kg For final mixing octagonal mixer – 500kg. Compression machine 42 produces 1 lakh

tablet in 1 hour..Coating 16 inch pan size can coat 50,000 tabs

at a timePacking-strip & blister(single track) can pack

3 lac tab. Per day The width of packing used is 150nm.

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GRANULATION:

Wet GranulationDirect CompressionDry Granulation

– OR Slugging – OR Roll Compaction

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GRANULATION STAGES ( flow sheet of granulation)

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Direct Compression:

Direct compression is Compressing tablet directly from powdered material without modifying the physical nature of the material. It was reserved for small group of crystalline chemicals having physical properties for the formulation of a good tablet.

Dry Granulation (slugging) :-

Dry granulation is used when…… Effective dose of drug is too high for direct

compressionDrug is sensitive to heat or moisture or both.

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ROLLER COMPACTOR

The capacity of the machine is upto 200 kg.

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WET GRANULATION: -

In this method the powder constituents are converted to a moist cohering mass by the incorporation of granulating fluid. Granules formed by passing the moist mass through a screen and dried, rescreened to breakdown agglomerates and blended with other tablet additives such as lubricants and disintegrate and then compressed to tablets.

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Classification of Equipments for wet granulation:-

A) High shear mixer / granulator:- includesLittleford lodige mixerLittleford MGT GranulatorGral mixer /GranulatorDiosna mixer / Granulator

B) Granulator with Dryer :- IncludesFludised bed GranulatorDay Nauta Mixer ProcessorDouble Core/ Twin Shell GranulatorTopo Granulator

C) Specialized Granulators :- IncludesRoto GranulatoMarumerizer

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DRYING OPERATIONS:-

•Fluidised bed dryer :-

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Principle :- When a gas is allowed to flow through a bed of

particulate solids at a velocity greater than the settling velocity of the particles.& less than the velocity for pneumatic conveyor, the solids are buoyed up & become partially suspended in the gas stream. the resultant mixer of solids & gas behaves like a liquid & solids are said to be fluidized.

Dryer capacities range from 5kg to 200kg.average drying time is about 20-40 min.

Advantages:- 2-6 fold advantage in thermal efficiency over tray

dryer. Faster in both drying & handling time than the tray

dryer. Higher drying temp can be applied than tray & truck..

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COMPRESSION MACHINE:

Tablet machine is regulated by..Number of tooling setsNumber of compression stationRotational speed of the press

Different stages of compression:

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HAND OPERATED TABLET MACHINE

ROTATORY TABLET MACHINE

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COATERS:- GENERAL TYPES OF

COATING EQUIPMENT (1) Standardized coating pan

• Loading capacity of the pan is upto 275 kilogram.•Motor with horse power of range 0.5 to 5 is available of spraying.•This coater is available with S.S. 304 and 316.

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FLUIDIZED BED COATER:-

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This coater is available with SS 304 AND SS 316 quality.

Pharmaceutical granules with 20-25% moisture can be dried in 30-45 mins.

Load about 300 Kg can be placed.Motor of horse power 1.5 to 25 is used.Length is about 650-2250 mm. width is about

750-1900 mm and height of the equipment is about 1550-3550 mm.

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CAPSULE

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INTRODUCTION

Capsules are gelatin shells filled with the ingredients that make up an individual dose.

Dry powders, semi-solids, and liquids that do not dissolve in gelatin may be encapsulated.

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TYPES OF GELATIN CAPSULE

1. Hard Gelatin Capsule

2. Soft Gelatin Capsule

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HARD GELATIN CAPSULE SIZES AND THEIR APPROXIMATE CAPACITIES

29PAPER

910201/HIMANSHU/M.PHARM/2009-10

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PLANT LAYOUT FOR CAPSULE MANUFACTURING DEPARTMENT

ENVIRONMENT CONDITION FOR CAPSULE FILLING AREAHumidity: Not more than 35% RHTemperature: Not more than 25%

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STEPS OF MANUFACURING OF HARD GELATIN CAPSULE SHELL

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GELATIN SOLUTION

DIPPING

SETTING

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DRYING

TO AUTOMATICS

STRIPPING

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CUTTING

JOINING

FINISHED CAPSULE

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GELATIN SPECIFICATION FOR HARD GELATIN CAPSULE

GELATIN PROPERTIES PIG SKIN FISH

BLOOM(G)0 240-255, 220-260

+MOISTURE (%MAX) 13.0 13.0

ASH (%MAX) 1. 1.0

PH ,1% SOLUTION 5.2-5.8 5.5-6.0

ISO IONIC POINT,PH 7.0-9.4 7.0-9.4

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GELATIN PROPERTIES PIG SKIN FISH

PARTICLE SIZE %

PASSING 4 US #

100 100

SO2 (PPM MAX) 40 40

H2O2 Absent Absent

MICROBIAL STANDARDS  

TOTAL COUNT 500 500

E.COLI IN 10 GM Absent Absent

P. AERUGINOSA IN 10

GM

Absent Absent

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A. DIRECT FILLING METHOD

1. AUGER FILLING METHOD

2.VIBRATION ASSISTED FILLING

FILLING OF CAPSULE

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B. INDIRECT FILLING METHOD

1. TAMP-FILLING METHOD

2. DOSATOR NOZZLE MACHINE

3. VACUUM-FILLING METHOD

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GENERAL REQUIREMENT

The environment condition in which filling of hard gelatin capsule should be normally carried out is:Humidity: Not more than 35% RHTemperature: Not more than 25 ̊ C

These conditions should be maintain even work has stopped at the end of working day and during the week- ends.

The area around machine should be kept clean at all times. Spillage should be cleaned up promptly.

The machine must be thoroughly cleaned during the week –ends and when there is a product change –over.

The speed gear should not be adjusted when the machine is running on power,

Operator should wear rubber gloves, nose mask and head covers when the machine is operated for filling.

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PLANT LAYOUT FOR SOFT GELATINE CAPSULE

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COMPOSITION OF SOFT GELATIN CAPSULE SHELL

FORMULATION EXAMPLE

Gelatine

PlasticizerGlycerine

Sorbitol

Water

PreservativeMethyl paraben

Propyl paraben

Colorants Certified lakes

Opacifier Titanium dioxide

Flavouring agent Ethyl vanillin

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STEPS OF MFG.OF SOFT GELATINE CAPSULE

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GELATIN SPECIFICATION FOR SOFT GELATINE CAPSULE

GELATIN PROPERTIES ACID OSSEIN FISH

BLOOM(G)0 180-210 160-210

MOISTURE (%MAX) 13.0 13.0

ASH (%MAX) 1. 1.0

PH ,1% SOLUTION 5.0-6.0 5.0-6.0

ISO IONIC POINT,PH 6.0-8.0 7.0-9.4

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GELATIN PROPERTIES ACID OSSEIN FISH

PARTICLE SIZE % PASSING

4 US #

100 100

SO2 (PPM MAX) 60 60

H2O2 (MAX) 60 60

CLARITY (45% solution in

30% glycerol)

Clear no precipitate

MICROBIAL STANDARDS

TOTAL COUNT 500 500

E.COLI IN 10 GM Absent Absent

P. AERUGINOSA IN 10 GM Absent Absent

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GELATIN MASS PREPARATION

The Shell of the Soft Gelatin Capsules comprises of pure Pharmaceutical grade Gelatin, a plasticizer (usually Glycerin), and other ingredients.

Gelatin Shell raw Materials are accurately weighed and then treated with demineralized water and melted under vacuum in large stainless steel pressure tanks.

Completed batches are then transferred to the production lines in heat controlled receiving tanks in which the gelatin mass are maintained at the required temperature and viscosity.

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 ENCAPSULATION PROCESS:

GLOBEX METHOD

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• The lipophillic fill and the shell formulation are stored in separate containers, both kept warm.• The fill and the shell material are pumped through a concentric double capillary, with fill in the inner one. The fill is pumped in pulses to give fill volumes between 20 to 600 mg.• Here, the formation of capsule depends upon the interfacial tension between the fill and shell material.• The shell material possesses a higher surface tension. In attempt to reduce the surface tension, the droplet is formed. As a result of this the seamless round soft capsules are formed.• The end of the double capillary is immersed in a cooling bath containing a liquid usually liquid paraffin which is kept at about 4 ˚C.

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Advantages:◦ Seamless capsules, which are tamper-

evident.◦ Free of contamination or air entrapment.◦ Risk of leakage is minimal.

  Capacity:o 10,000-40,000 capsules per hour.

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ROTARY DIE PROCESS

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