WO2006059342A1

WO2006059342A1 - R & d coater for pharmaceutical products

Info

Publication number: WO2006059342A1
Application number: PCT/IN2005/000130
Authority: WO
Inventors: Chetan Rajsharad; Ashok Mohanty
Original assignee: Ideal Cures Pvt. Ltd.
Priority date: 2004-12-03
Filing date: 2005-04-26
Publication date: 2006-06-08
Also published as: BRPI0518814A2

Abstract

The present invention provides an equipment of about a laboratory scale for applying different types of coating material (water based or organic solvent based) on solid dosage forms of pharmaceutical products, such as tablets / granules / pallets / capsules or other solid presentations of nutritional, confectionary, cosmetic, food products, agriculture products like seeds and veterinary products, comprising a rotary coating pan (1), an air blower mechanism (2), an air heaters (3), an exhaust system (4), a spray gun (5) with an adjustable stand, a peristaltic pump (6), and an advanced control panel (7) to allow adjustment and measurement of the coating parameters during the whole operation.

Description

TITLE

R&D Coater for Pharmaceutical Products.

Description

BACKGROUND OF THE INVENTION

1. Field of the Inversion

The present-invention relatesJo theequipment for coating,

solid presentations forms, of pharmaceutical products,

such as, tablets,- granules,, pallets,, capsules, or qther

pharmaceutical preparations, confectionary, nutritional,

cosmetic foodstuff ,_ veterinary,, and. agriculturaLptoducts.

The equipment enables, to perform the. test Qt coating

production of solid, presentations forms, of

pharmaceuticals_^ neutraceuticals,. confectionary,- cosmetic,

food products,

and veterinary products in small scale, from 50 grams to 1000

grams.

2. Description of the Prior Art

Known prior art equipments used for coating solid forms

of pharmaceutical, nutritional,, veterinary, agricultural

products for. stability testing or for the development of

coating formulations or colour demanded a reasonable

large product volumes. Such prior- art machines have a

number of technical difficulties as the equipments known

to technicians are middle size and most of the equipments

are multi-component systems where the user has to

procure different components from different manufactures

and assemble them at his application site.

The additional disadvantage of the conventional

equipment is that they are very inconvenient as not only it

occupies lots of floor space in the laboratory but also the

maintenance of such equipments is very difficult. The equipment available for coating gives rise to

economical disadvantage as the volume of material

required to be tested being fairly high resulting to large

batch of product needed for the test. Further although the

tests signaled the desired results, making it possible the

normal or commercial operation, the high cost of these

tests ended up being added to the product's cost, causing

price increases.

Some of the machinery manufacturers- have tried to

address this issue of large volume product required for

testing by developing- various design of equipments,

however such conventional prior equipments are very

complicated, expensive. and alL the more Laborious, nature

in which for which highly skilled operator needs to- handle

such machines.

U. S. Pat Nos. 4,-133,290. (January 9, 1979). provides, an

apparatus and process for automatically coating, solid pharmaceutical dosage forms e.g. tablets. The entire

process is carried out by taking a huge quantity of product

set out in the example where in one hundred-seventy

kilos of tablets (Approximately 1.1 million tablets) are

charged into a 300 kilogram Pelligrini coating pan.

U. S. Pat Nos. 4,554,887 (November 26,1978) discloses

pthe equipment for coating medical tables and pallets with

a protective film at commercial scale.

U. S. Pat. Nos. 4,050,406 (September 27_r 1977) being a

machine for sugar coating articles of confectionery, or

pharmaceutical or like products however the same is

specifically and onLy for sugar coating articles.

U. S. Pat Nos. 3,991,225 (November _9, 1976). being an

invention of machine for uniform coating system.

U.S. Pat 3,937,176 (February 19, 1975) is a conventional

apparatus for tablet coating and polishing. SUMMARY OF THE PRESENT INVENTION

The present invention seeks,, therefore, to provide a machine

for coating solid presentations forms of pharmaceutical

products, such as, tablets, granules ,_ pallets, capsules,, or other

pharmaceutical preparations, confectionary, nutritional,

cosmetic foodstuff, veterinary, and agricultural products in

which the above mentioned structural_^ economical apd

functional disadvantages of known prior art machines are

overcome.

This invention is aimed to have compressed form of portable, if

necessary, equipment by means of improvements, innovations

and alterations needed in the machine, design so thaLsmall

quantities of the products can be easily tested with quick and

economical reproducible result and wherein water based

coating compositions for solid particles can also be used. The new equipment presents many advantages when

compared to up-to-date available equipments -

a. reduces the consumption of product to perform

development / stability test;

b. reduces the quantity of coating material needed to

perform the test;

c. reduces the quantity ot solvents required during. s,uch

tests;

d. allows trie utilization, of aqueous coating systems as

well as organic solventbasecLcoating- systems;

e. it is small size, allowing, portability;

f. it occupies Less floor spaceJrLtheJaboratory;

g. the machine is_ very simple and- easy to operate, and

clean, also consumes less energy per test.

According to the present invention an equipment that is

required in the laboratory scale to apply different types of

coating material (water based or organic solvent based) on

solid dosage forms of pharmaceutical products, such, as tablets / granules / pallets / capsules or other solid

presentations of nutritional, confectionary, cosmetic, food

products, agriculture products like seeds and veterinary

products, comprising of rotary pan for coating where the

solid particles to be coated are placed in its interior, this pan

keeps spinning on its axis during the coating operation, the

air blower mechanism provides the hot air necessary to dry

out the solvent used to apply the coating material onto the

solid particles and air heater required to heat the air supplied

by the air blower, the exhaust system remove gases /

solvent vapours / solid residue generated during the coating

process thereafter spray gun attached to an adjustable stand

spray the coating solution / suspension homogeneously onto

the solid particles, the peristaltic pump delivers the coating

solution / suspension to the spray gun and controls the spray

rate at any desired level. The advanced control panel allows

adjustment in all the critical coating parameters independent

to each other, thus making all the parameters measurable

and controllable separately. Other object and further scope of applicability of the present

invention will become apparent from the details given

hereinafter; it should be understood, however, that the

detailed description and specific examples, while indicating

preferred embodiments, of the invention, are giuecLby way of

illustration only, since various, changes and_ modifications

within the spirit and scope of the invention wilL become

apparent to those skilled in the art from this detailed

description.

BRIEF DESCRIPTION OF THBDRAWINGS.

Various embodiments of the invention will now be more

particularly described, by way at example with reference tp the

accompanying drawings, which are glvenJiyjωay .of example

only and thus are not limitative of the present invention, and

wherein:

Picture 1 shows the frontal partof the equipment according to

the invention: Picture 2 shows a transversal cut view of an unit according to

the invention

Picture 3 describes control panel.

DETAILED DESCRIPTION OF THEPRESETtNVENTION

Picture 1 shows the frontal part of the equipment according to

the invention:

Rotary Coating Pan_(1) is where the solid particles- to be

coated are placecLiruts interior,- this pan keeps spinning^ on

its axis during the coating operation. It is in. the form of a

cylindrical or round drum made otstainless steel 316 witft an

opening in the front for loading and. unloading of tahlets /

capsules / seeds. Baffles (fixed or removable) are fixed to

the inner wall of the coating-pan. The pan can be remqved

very easily from the motor shaft (by unscrewing the bolt, with

which it is attached) for maintenance and cleaning purpose

and is available in several sizes (4", 6", 8" or 12"). The coating pan rotates, powered by an electric motor to which it

is connected and that is located on a support base (12).

Air Blower (2): air blower mechanism provides the hot air

necessary to dry out the solvent used to apply the coating

material onto the solid particles; it injects or blows heated air

over the solid particles at temperature needed to dry out the

tablets, through a stainless steel tube (9), suitable electric

heaters (3) are placed in this tube. The temperature of the

air can be controlled from 30 to 90 degree Celsius.

Air heater (3) to heat the air supplied by the air blower (2);.

Exhaust System (4): exhaust system remove gases / solvent

vapours / solid residue generated during the coating process;

an exhaust blower is fitted inside the main support base

which eliminates the solvent vapours and undesirable solid

particles (generated by tablets and coating material) coming

from the coating pan. Such vapours and solids pass through

a stainless tube (10) attached to the exhaust blower. Spray Gun (5) : spray gun attached to an adjustable stand to

spray the coating solution / suspension homogeneously onto

the solid particles. It distributes the coating solution /

suspension in the form of fine droplets over the tablet's bed

or the solid particle's bed to be coated. The spray gun is

made of stainless steel preferably SS 316 as it handles the

liquid preparations containing coating material and various

solvents. The liquid supply tube to the spray gun is attached

to the Peristaltic Pump (6) or any other suitable pumping

device which can accurately control the liquid delivery rate.

The spray gun is also attached to compressed air line

(attached with pressure regulator and filters to remove

condensed water / oil from the compressed air) for atomizing

the liquid into small droplets. The spray gun is attached

externally, near the coating pan, on an adjustable stand (11)

so as to accurately adjust the spray angle and the distance

between spray gun and the tablet bed. Peristaltic pump (6) to deliver the coating solution /

suspension to the spray gun and control the spray rate at

any desired level;

Control Panel (7) : advanced control panel which allows

adjustment in all the critical coating parameters independent

to each other, thus making all the parameters measurable

and controllable separately.

The advanced control panel offers total control over, the

several process adjustments and caa easily be automated

by using PLC or SCADA software for recording the process

parameters during the coating process. The control panel

offers indication to the operator about parameters referring

to :

coating pan rotation

exhaust air

hot air blower

Air heaters

Peristaltic pump rotation Hot air temperature

Coating pan speed

Peristaltic pump speed

The main electric supply switch

Main Support Base (12) : the rotary coating pan (1) along

with support base (12) and the control panel (7) are mounted

on the main assembly (8). The adjustable spray gun stand

(11) is fixed in the front side so that the spray gun can easily

be directed towards the solid particles to be coated. The

main motor (13) the air blower (2), the exhaust system (4)

and the peristaltic pump (6) are placed inside the main

support base which itself is placed on a wheeled stand (14)

for adjustment of the machine location and to make it

portable. The support base as well as wheeled stand is

made of stainless steel preferably SS 316.

The control of the equipment's working parameters is empiric,

which can be varied based on the requirement of the coating

material and the substrate to be coated. The operator must preferably check the temperature of the solid particles to be

coated inside the coating pan using any suitable temperature

measuring device in order to adapt the parameters to keep

constant the desire temperature of the solid particles

substrate.

All the above described parts are fitted together in a ve,ry

compact design so that it becomes very convenientfor the

user to operate the machine and get the best results in the

most economical and fastest possible manner.

According to the invention,- the equipment is an integrated

and semi-automatic unit composed of a rotary coating pan, a

spray gun system, a hot air^blower and an exhaust system

where all the contact parts are made of stainless steel (SS

316). It uses the kinetic rotary, force of the coating pan to

spread the tablets / granules contained in the pan. The

baffles / detectors are attached on the inner wall of the pan

to mix the contents homogeneously, obtaining an efficient

coating operation. Due to the fact that the film coating needs a spray technique for uniform film formation, a spray gun

distributes the coating suspension in the form of a fine misty

spray pattern consisting of uniform droplet size over the

rotating tablet bed ensuring this way an even coating. The

tablet drying is made through hot air directed towards the

tablet bed surface while the exhaust system takes care of

solvent vapours and other dust particles generated during

the operation.

The hot air blower and the heaters attached to it keep the air

intake temperature between 30 and 90 degrees Celsius, to

obtain a controllable performance. All the adjustments,

including rotation speed, temperature, peristaltic pump

speed (Spray rate) can be precisely measured and adjusted

through the advanced control panel.

Picture 2 shows a transversal cut view of an unit according

to the invention indicating a coating pan (1) supported

tangentially from 35 to 90 degree related to the assembly

base (8). The drive mechanism is located in its interior, only the rotating pan and the support axle for the pan is externally

located to enable the vertical kinetic rotary force.

The following are examples to illustrate and to make

knowledge about the coater as clear as possible.

Example 1 :

In this example the technical specifications of the equipment

made according to the invention:

Example 2:

Initially a tablet coating solution was prepared, containing, the

following components:

coating material (based oα suitable polymer and

colourants)

solvent (can be de-ionized water, isopropyl alcohol,

methylene chloride, ethanol, methanol, acetone or_any

other suitable solvent)

solution volume; may vary from 10 ml to 200ml

depending OΓL the quantity, of coating to be applied,

mass and kind of tablets to be coated.

Generally, the instructions supplied by the coating material's

supplier are followed.

The tablets to be coated are placed in the coating pan (quantity

can vary from 50 gm to 1000 gm, depending on the need oj| the

test to be carried out), and the coating operation is performed

as per the desired parameters.

Upon ending the. coating operation, the tablets presented

excellent coating results.

Claims;

What we claim as new and desire to secure as our invention

1. A compact, improved equipment, to. apply coating . on. jsolid

presentations, of pharmaceutical, nutritional, cosmetjc,

foodstuff, veterinary.ancLagricultiiral products comprising of:

Claims

Claims.

What we claim as new and desire to secure as our invention

1. A compact, improved equipment. to_ apply coating . on. jsolid

presentations, of pharmaceutical, nutritional, cαsmetjc,

foodstuff, veterinary.ancLagricultural products comprising of:

a. rotary pan for coating (1), in which are placed the solid

particles to be coated, and which is rotated during the

coating operation:

b. air blower mechanism (2), needed to dry out the solvent

used to apply the coating material;

c. intake air heater (3), to heat the air supplied by air blower

(2);

d. exhaust system (4)_rto remove solvent vapours ancLςolid

residue originated by the coating process;

e. spray gun (5), through which, coating, material is sprayed

on the solid particles to_be_ coated and is attached to an

adjustable stand (11);

f. peristaltic pump (6), to_ control the spray ,.rate_ αf_ the

coating suspension;

g. advanced control, panel (7)_^ which enables adjusting, the

whole operation.

or according to Pictures 1 ,_or 2. or 3 annexed.

2. The equipment for coating solid presentation as claimed

in claim 1 wherein the main motor (13), air (2), exhaust system (4) and peristaltic pump (6) are placed in its interior.

I. The equipment for coating solid presentation, as. claimed

in claim 1 wherein the spray gun (5) to be supported on

an adjustable stand (11), the rotary coating pan (I), are

the external parts of the equipment.

k The equipment as claimed iα claim 1 is characterized, by

the fact of presenting an_ element responsible, for heating

(3) the drying air supplied by air blower for drying the. solid

particles during the coating operation.

i. The equipment as claimed in, claim 1 is characterized by

the fact of presenting an element responsible for removal

of solvent vapours and residual solid waste through the

exhaust tube (10)

i. The equipment as claimed., in claim 1 is characterized by

the fact of presenting an externaL control _ panel (7) to make it easier for the operator to adjust the control

parameters such as, temperature, peristaltic pump speed,

pan rotation speed, and switches; main, air blower, heater,

exhaust, pan rotation, peristaltic pump rotation, among

other possible^ ones, the recording of the coating

parameters during the operation is achieved . by

automation of the panel by using SCADA software of PLC

system.

7. The equipment as claimed, in claim 1 to 6 is placed on a

wheeled stand (14) to make it portable.

8. The equipment as claimed in claim 7 is a small compact

machine for conducting small coating tests on solid

presentations of pharmaceutical, nutritional, cosmetic,

foodstuff, veterinary and agricultural products.