Hard gelatin capsules

INTRODUCTION CAPSULE SHELL MANUFACTURE CAPSULE FILLING MACHINES FILLING OF DOSAGE FORMS FINISHING

Easily swallowed. Beneficial for drugs having an

unpleasant taste. Highly soluble materials and

deliquescent materials should not be used.

Capsules made with methylcellulose, polyvinyl alcohols, denatured gelatin give enteric effect.

INTRODUCTION:

IT CONSISTS OF FOLLOWING STEPS: DIPPING ROTATION DRYING STRIPPING TRIMMING JOINING

CAPSULE SHELL MANUFACTURE:

Eli lilly and company,Indianapolis. Farmatic SNC,Bologna,Italy. Hofliger and karg,Waiblingen,Germany. Macofar SAS,Bologna,Italy. mG2,Bologna,Italy. Osaka,Japan. Perry industries,Green Bay,WI Zanasi Nigris,Bologna,Italy.

CAPSULE FILLING MACHINES:

Rectification: The empty capsules are oriented so that all point the same direction i.e, body end facing downward

Seperation of caps from bodies: Here the rectified capsules are delivered to split bushings.

Dosing of filling material: It has some dosing devices.

Replacement of caps: Filled capsules are ejected.

Several types of filling machines in pharma industry have common following operations

1. Bench scale filling: this is manual filling. It contains 200-300 holes which produces 3000-5000 capsules per hour.

The filling of hard gelatin capsules are of following types:

Dependent: dosing systems that use capsule body directly to measure the powder. Uniformity in the fill weight can only be achieved if the capsule is filled completely.

Independent: dosing systems where the powder is measured independently of the body in a special measuring device. Weight uniformity is not dependent on filling the body completely.

2.Industrial scale filling: in this dosing systems can be divided into two groups.

In these dosing systems filling is done by using THE AUGER.

Empty capsules are fed into a pair of ring holders The body holder is placed on a variable speed

revolving turntable. The powder hopper is pulled over the top of this

plate , which revolves underneath it. In the hopper a revolving auger forces powder

down into the capsule bodies. Example of this type of system is ELI LILLY

company capsule filling machine.

Dependent dosing systems:

1) Storage hopper.2) Rectifying unit.3) 3A and 3B two piece filling ring.4) Powder hopper.5) Peg ring.6) Closing plate.7) Collection chamber. this is semiautomatic machine. Pelletized or granular materialsmay be readily filled using thisequipment.

LILLY/PARKE-DAVIS: It has a output of 200,000 capsules.

Machines which use this kind of dosing mechanisms form a plug of powder which is a soft compact formed at low compression forces.

There are 2 types of plug forming machines.1. Dosators.2. Tamping finger and dosing disc systems. Dosators: these machines consists of a dosing

tube inside which there is a movable spring loaded piston. It is lowered into bed of powder and forms a plug. This assembly is then raised from the powder bed and positioned over the capsule body.

Independent dosing systems:

Examples of machines that use this system are:Zanasi , Macofar. mG2 , Farmatic.

ZANASI MACOFARoutput -9000-20,000. output-5,000-35,000.

used for filling of pellets ,powders ,tablets .

Mainly used for filling of powders.

mG2 G36 FARMATIC

G36-150,G37-1600,G38-1000 capsules per minute.

Output 40,000-80,000 capsules per minute.

the dosing disc forms the bottom of a revolving powder hopper.

This disc has a series of set of accurately drilled holes in which sets tamping fingers-stainless steel rods are lowered to form powder plugs.

Tamping finger and dosing disc:-

Models are GKF-303,GKF-602,GKF-1500,GKF-2500.

The number indicate capsules output.

Example is HOFLIGER AND KARG model:

The only model available is R-180 which has a rated capacity of 70,000-1,65,000 capsules per hr.

The unique powder filling principle used is vibration. Vibrators are externally controlled.

PERRY: 24 vertically operating cam controlled empty

needles are immersed into the powder bed and vacuum is applied.

A sensor system is present which prevents the ejection of powder in the absence of a capsule body . Output is 60,000 capsules per hr.

OSAKA:

Pellets:filled on industrial scale using machines adapted for powder use.These are not compressed but held inside the measuring device by applying suction in dosing tube.

Tablets: placed in hoppers allowed to fall down tubes at bottom of which is a gate device that will allow a set number of tablets to pass.

Semisolid and liquids: by using volumetric pumps. semisolids that are solid at ambient temperatures can be liquified before filling.

Filling of different dosage forms:

Sealing: normally capsules are self locking by forming identations or grooves inside of the cap and body portions.

Hermetically sealed with a colored band of gelatin.Another process that uses a liquid wetting agent

that lowers the melting point in the contact areas.

Pan polishing: accela cota tablet coating pan may be used to remove dust and to polish capsules.

a polyurethrane or cheese cloth liner is placed in the pan to trap the removed dust.

Finishing:

Cloth dusting: this is hand operation , capsules are rubbed with a cloth. It imparts gloss.

Brushing: used to remove dust under rotating shaft brushes.

Stability considerations: capsules should not be exposed to high humidity conditions. The removal of moisture should be sufficient.

The Science of dosage form design by M.E.AULTON; 2nd edition, Elsevier publication, pg no:449.

The theory and practice of industrial pharmacy by LEON LACHMAN, 3rd edition, Varghese publishing house, pg no:374.

ANSEL′S pharmaceutical dosage form and drug delivery systems, 8th edition, B.I. Publications, pg no:204.

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