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Umang Pharmatech pioneers in pelletisation technology
Pharma India'99- Supplement to Express Pharma Pulse November 1999 |
Pellets are being increasingly used in the manufacture of sustained release drugs. The advantages of the sustained release drugs are well known. Some of them are:
Obsessed with the dream to fulfill entrepreneurial zeal & backed by two decades of engineering experience in the pharmaceutical industry with MNCs like German Remedies Ltd & Bayer India Ltd, Mr. R. Budhraja -The Managing Director had a very modest beginning in the pharmaceutical industry & then floated his own company, Umang Pharmatech Pvt.Ltd (UPPL). He was the one who pioneered the concept of machinery for Sustained release drugs in India which is based on the pelletisation technology.
The pelletization technology is useful for both sustained release drugs and immediate release drugs.
UPPL offers an entire range of products mainly meant for making pellets(beads) The Extruder, The Spher'oidizer , Drug Layering Machines , the Fluid Bed Coater & oflate the latest successful development has been that of the Fluid Bed Processor. The team at UPPL believes in continuous development and research related activities. A whole range of inovative products have been and continue to form the backbone for the growth of their organisation.
Their main strength has been their various customers who believe in them. Their clientele list includes most of the top pharmaceutical giants, most of them who have gone in for re-purchase of our machines in light of their expanded activities. Not only have the local companies reposed faith in their capabilities, their machines are also being used in Cyprus, China, Nepal & Malaysia.
Keeping in mind their goal- to provide all that it takes, to ensure the success of our customers, they have been providing various facilities. Thier clients use their infrastructure to conduct the trials on the products. Many of their clients also utilise UPPLs facility, wherein they provide UPPL the material, and they conduct trial on their behalf and send them the results.
Their latest development has been successful Powder (Particle) Coating in the Fluid Red Coater. Their Clients are successfully using the Fluid Bed Coater for coating clarithromycin, roxythromycin and successful trials on omeprozole, lensaprozole pellets and lobrophen and cephalexim particles have been conducted.
PELLETIZATION TECHNOLOGY
The pelletisation technology is useful in the following cases:
Controlled Release Products
The pellet form provides a smoother absorption profile from the gastrointestinal tract as the beads pass gradually through the stomach into the small intestine at a steady rate.
In contrast the whole tablet is released at once into the small intestine as the stomach empties itself.
Different types of pellets can be coated with different drugs to enable the controlled release rate. All these can be combined in a single capsule to obtain the desired results.
Immediate Release Products
Administering the drugs in the pellet form leads to consumption of the drug which have a increased surface area as compared to traditional compressed tablets and capsules.
This would considerably reduce the time required for disintegration.
Chemically Incompatible Products
At times such ingredients are required to be delivered in a single dose.
In the conventional tablet dosage separate tablets would have to be administered but the pellets can be administered in a single capsule.
Varying dosage without reformulation
Pellets have excellent flow properties. Due to this they can be conveniently used for filling capsules & the manufacturer can vary the dosage by varying the capsule size without reformulating the product.
CHEMICAL INDUSTRY
The extrusion & Spher'oidisation machines are being increasingly used by the chemical and the clients of such other industries to avoid powder dusting for the intermediate as well as final usage. One of their clients Hindustan Lever Ltd is succesfully using our extrusion & Spher'oidization machines for making sodium salt pellets. BARC also uses their machines successfully for its applications.
The currently popular method for producing pellets is extrusion. Spher'oidization and fluid bed processing. Another method is the layering technology. Increased applications of the fluid bed processing machines are for powder (particle size from 150-350 microns) coating.
Range of products:
- Fluid bed coater for particles and pellets
- Extruder and Spher'oidizer
- Drug Layering
- Coating Pans
- Mixers
- Lab Coaters
EXTRUDER
- It is used for converting the powder material (which does not get sticky when mixed with binders) into extrudes/granules.
- A dough is prepared & fed into the feed hopper. Uniformly sized extrudates are formed by pressing through the die roller & the knurling roller.
Unique features:
- Length of the extrudates can be adjusted.
- All contact parts are SS 316Q.
- AC drive for speed control with digital RPM indicator.
- Change of extrusion diameter/pellet size by changing the roller.
- Continuous cooling arrangement during extrusion operation for pressing roller.
- Direct connection from extruder to Spher'oidizer.
- Upto 96% uniformity (substantially formulation dependant. But guidance on this aspect is provided).
- Output capacities range from 10 kgs/hr to 500 kgs/hr depending on the model size.
- Size of pellets varies from 0.8 mm to 5 mm.
SPHER'OIDIZER
The spher'oidization process is the extension of the extrusion process ie. It is used to convert the extrudates of uniform length and uniform extrudates into uniform pellets.
Principle of operation
The extrudates are put on the chequered plate of suitable pitch and they are converted into spherical beads with the help of the chequered plate & the centrifugal force created during the spher'oidization process.
Unique features
The pellet size can be varied by changing the extruding roller & chequered plate.
The chequered plate is rotated in the fixed bowl. The gap between the bowl & the plate is reduced to the minimum to avoid powders from falling down & beads being crushed in the process of rotation.
The desired rpm is achieved as the machine is fixed with AC drives.
Each extrudate coming in contact with the chequered plate is broken in length to its own diameter and then due to the tumbling & rope effect of the beeds & proper formulation it converts them into proper small spheres.
The machines are provided with the compressed air connection to facilitiate the operation of rope formation to avoid the crushing of the pellets and also to avoid the powder from going into the bearing assembly.
In certain cases the compressed air connection is used to dry the pellets when the moisture content is high.
All contact parts are made in SS 316Q.
Drug Layering attachment possible.
Output capacities range from 200 gms/batch to 70 kgs/batch.
The materials successfully converted on the machine to pellets are: Indomethacin, Dibasic-calcium phaosphate, Calcium Phosphate, Vitamin'C', Multi-vitamins, Caffeine, Omeprazole, Nifedipine, Theophylline, Guaifenesine, Sodium Laurel Sulphate, Ferrous Sulphate, Folic acid, low sodium salt, resist salt magnesium oxide, nifedipine, Di clofenac sodium, ayurvedic products and many more.
FLUID BED COATER
It is used for coating of beads & powder above 75 microns. Recent trend has been to use the fluid bed coater for particle coating for taste masking, administer non-compatible materials in a single dose or to create particles for controlled release.
Principle of operation
-The beads are kept in the product chamber and are coated with the solution with the help of a Wurster design product chamber with the bottom spray nozzle and partition in the middle.
-The beads when coated with the solution are airborne to such a height that when they reach near the filter assembly they start falling back and are fairly dry when reaching back in the product chamber for further coating.
-Top spray aggloremations attachment are possible.
-This process continues till the desired level of coating is achieved.
Unique features
-Tri-clover joints conforming to GMP standards and minimum cleaning and dismantling time.
-Speed can be adjusted as the machines is fitted with AC drive.
-This machine can be used for both bead coating & particle coating by merely changing the product chamber.
-The movement of the beads is so designed that the beads & the coating solution are concurrent & the coating occurs with the minimum loss of the spraying solution.
-The design of the machine is such that the particles are nearly dry when they reach the filter assembly ensuring no agglomeration.
-All contact parts are made in SS-316Q.
-PLC Controls possible.
-Batch capacities range from 200 gms to 300 kgs
DRUG LAYERING MACHINE
One of the processes for manufacture of pellets is the layering process. This process involves deposition of successive layers of an active compound onto the granules of the non pareil seeds or active compound resulting in formation of uniform sized pellets.
Operating Principle
-The desired quantity of pellets are put on the plain plate of the spher'oidizer. This plate is rotated.
-The binding solution and the dry powder is sprayed with the help of spray nozzles fixed with the machines.
-The dry powder is sprayed onto the beads wetted with the binder with the help of a powder feeder.
-The process of layering continues as per the total drug layering required on the pellet.
-The beads are then transferred to the fluid bed dryer for drying or hot air may be passed from below the plain plate in the spheroidizer.
-It is presently being used by Cipla Ltd. For lansaprozole, the layering is approximately ten times faster than the conventional process by coating pan. A bathc of 25 kgs is completed within 30 minutes.
Unique Features The required rpm is achieved on the latest models as -they are fixed with AC controls.
-This ensures that the complete powder is consumed for layering and minimal powder adheres to the plain plate or the sides of the spher'oidizer.
-The machines are fixed with three spray nozzles to enable selection of the spray nozzles as per the batch size in operation.
It can also be used to increase the size of the pellets. Pellet size can be layered from 1mm to 12 mm in diameter.
-Output capacities range from 1kg/batch to 70 kgs/batch.
NEW PRODUCTS BEING OFFRED BY UPPL
Fluid Bed Processor
The team at Umang Pharmatech believes in continuous advancement. Hence to keep in tune with the customer requirements with regards the pelletisation technology they have started developing the Fluid Bed Processor.
This machine is in the advance stage of development. In this machine it will be possible to make the beads from powder, that is, the process of extrusion, spherodisation and coating on the fluid bed coater itself.
Thus the three processes on three machines are reduced onto a single machine. Drug Layering & coating would also be possible on the same machine.
They have the inhouse facilities for the development of the new product with the help of qualified personnel from the Industry & academic institutions. The clients are encouraged to avail of these faciities.
Lab Coaters
Used for laboratory size trials for particles and pellets. It is supplied with two chambers. One for pellet and particle coating and the other for drying and top spray aggloremation. It has a capacity of 200 gms. Batch for particles and pellets. Totally finished in SS 316, with or without PLC controls.
General machines manufactured:
-Tablet Coating Systems.
-Coating Pans.
-Mixers.
For further information contact:
Mr. Umang
Umang Pharmatech Pvt. Ltd.,
Plot No.23, Golani complex,
Valiv, Opp. Agrawal Hospital,
Vasai Road (E)- 401 208,
Maharashtra, India.
Tel: 0091-250-2454467/2453795/2456482
Fax: 0091-250-2452101 |
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