FORM 2
THE PATENT ACT, 1970
(39 OF 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
EMBOSSED HARD CAPSULE BY AN IMPROVED PROCESS


Scitech Centre
An Indian Company Registered Under the provisions of Companies Act, 1956. Having address at 7, Prabhat Nagar Jogeshwari (West) Mumbai -400 102

THE FOLLWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED


FIELD OF THE INVENTION
Present invention relates to an improved process for manufacturing embossed capsules. More particularly, present invention relates to an improved process for manufacturing embossed hard capsules by thermoforming process.
BACKGROUND OF THE INVENTION
There are available embossed capsules, which are manufactured by dipping process. The embossed capsule obtained by the process of manufacturing the dipping moulds of desired embossed artwork and then dipping the said moulds in the solution of either gelatin or HPMC or Pullulan or any other polymer suitable to manufacture capsules by dipping process, dipping capsule forming pin made specially into the solution so obtained at a predetermined temperature, then withdrawing the pin and inducing gelatin of the capsule preparing solution adhering to pin. The mould along with gelled mass is allowed to dry to attain the desired moisture. Those so dried shells are then stripped and cut to required size. The cut cap and body shells are then joined to get the pre-cfosed capsule with the required emboss design.
The process as described above needs the entire mould set to be manufactured. The mould manufacturing is very tricky, lengthy and costly process.
It is also observed that the polymer solution gets accumulated in the embossed area leading to increase in the film thickness in the embossed portion.
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It is also observed that the mould releasing agents does not get cleaned in the
embossed area. This leads to oil patches which are objectionable for some of the
formulations.
It is also observed that due to higher viscosity the tiny bubbles get accumulated in the
embossed portion.
OBJECTIVE OF INVENTION
The object of the present invention aims at developing an improved process for manufacturing embossed hard capsules.
It is also the object of the present invention to develop an improved process for manufacturing embossed hard capsules without using pre embossed dipping moulds.
It is also the object of the present invention to develop an improved process for manufacturing embossed hard capsules with uniform film thickness especially in the embossed area.
It is yet another object of the present invention to eliminate the formation of tiny bubbles in the embossed area of hard capsules.
It is yet another object of the present invention to eliminate oil spots and patches in the embossed capsules shell manufactured by the dipping process.

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SUMMARY OF THE INVENTION
The present invention provides an improved process for manufacturing of embossed
hard capsules from water-soluble polymers of gelatin or HPMC or Pullulan or any
other polymer having ability for form strong, flexible, clear and water soluble film.
The capsule manufacturing comprising steps of making complete solution or
suspension of polymer and adding the required additives / processing aids to make
the dipping solution and maintaining at appropriate dipping temperatures.
Then dipping the regular used moulds by applying of minimum quantity of mould
reteasfng agents and prcrkfng up the solution around mould.
Further allowing those moulds to rotate in the temperature of 10°C- 25°C and relative
humidity between 30 - 40 %. This causes the temperature of the wet mass picked up
to lower below 20°C. The lower temperature causes the viscosity to rise substantially
and allowing the mass to set. The capsules are then subsequently dried and cut to
required size.
The master embossed pins are manufactured of any text or shape such as dimple,
cone, concentric rings etc.
The capsules so manufactured are then pressed with preheated master embossed
pins of temperature ranging between 40 to 100 deg C (thermo forming process).
The shells so obtained are having embossed with uniform shell thickness.
No tiny bubbles are also observed in the embossed area.
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Since the capsule shells are manufactured by using regular moulds and using minimum application of mould releasing agents, no oil patches are also observed in the embossed area.
Improvement lies in manufacturing the shell by conventional method and forming emboss by using thermoforming process. This eliminates the need manufacturing full set of embossed dipping moulds.
DETAILED DESCRIPTION OF THE INVENTION
Present Invention relates to an improved process for manufacturing embossed hard capsules from water-soluble polymers. More particularly present invention is related to an improved process for manufacturing embossed hard capsules from water-soluble polymers such as gelatin, hydroxypropyl methyl cellulose, pullulan or any other polymer having ability for form strong, flexible, clear and water soluble film. The present invention provides an improved process for manufacturing embossed hard capsules from water-soluble polymers such as gelatin, hydroxy propyl methyl cellulose, pullulan or any other polymer having ability for form strong, flexible, clear and water soluble film comprising of steps of making complete solution or suspension of the polymer and adding the required additives / processing aids to make the dipping solution and maintaining at appropriate dipping temperatures. More particularly the polymer is hydroxy propyl methyl cellulose.
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Then dipping the regularly used dipping moulds in the above prepared solution by applying of minimum quantity of mould releasing agents. Then withdrawing the dipping moulds at pre determined velocity and picking up the solution around mould. Further allowing those moulds to rotate in the temperature of 10°C- 25°C and relative humidity between 30 - 40 %. This causes the temperature of the wet mass picked up to lower below 20°C. The lower temperature causes the viscosity to rise substantially and allowing the mass to set. The capsules are then subsequently dried and cut to required size.
The master embossed pins are manufactured of any text or shape or size as shown in the iiguTe such as dirnpie, cone, concentric rings etc. Care shoud be taken to make the artwork in reverse direction so as to get the proper embossed view.
The capsules so manufactured are then pressed with preheated master embossed pins of temperature between 40 to 100 deg C ( thermo forming process). More preferably the embossed pins are heated between 60 to 80 deg C. The preheated master embossed pins are pressed on the preformed shells by 0.05 to 5.0 mm depth. More preferably the depth is maintained between 1.0 to 2.0 mm. This gives a clear visible reverse impression of the artwork of the master embossed pins.
Improvement lies in pressing the heated master embossed pins on the preformed shells after manufacturing the shell by conventional methods. This gives the emboss of uniform film thickness. As the mould releasing agents can be cleaned / polished very effectively from flat or spherical surface of the dipping mould, no accumulation of

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mould releasing agent is observed. Since the conventional dipping moulds are very much in regular shape and without any sharp projections / depths, no tiny bubbles gets trapped while manufacturing hence no tiny bubbles are observed in the embossed portion which is done after formation of the shell.
Also due to more uniform shell thickness the filling machine performance is also found to be at par with shells which are not embossed.
This manufacturing procedure is only shown as one typical method. Our invention is related with the thermo forming of the conventionally manufactured shell does not limit the manufacturing methods.
The present invention shall now be specifically described by way of illustrative and non-limiting examples. It shall be understood that many variations and modifications thereto will be apparent to those skilled in the art without departing from the broadest scope and ambit of the invention as set forth herein above.
EXAMPLES Evaluation methods
Visual observation of embossed surface
The shell is observed with naked eye and with the help of 3x magnification for uniformity of emboss, generation of tiny bubbles.
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Accumulation of mould releasing agents
The shell is filled with green tea formulation or finely ground powder of liquorices. If the mould releasing agent is accumulated, it will show change in colour. This indicates the accumulation of mould releasing agent. Example 1
(1) 0.4 gm of Calcium gluconate is dissolved in 350 ml of distilled water (about 80°C). Total 100 gm of HPMC of 4.5 cps and 2910 chemistry is dispersed into this water (about 80°C). The temperature of HPMC dispersion is cooled down at about 25°C and HPMC is completely dissolved. And then the HPMC solution is heated at about 49°C.
(2) 0.95 gm of pectin is dissolved into 49.2 ml of water.
(3) Pectin solution is added into HPMC solution keeping the temperature at49°C.
(4) Capsule forming mould of size 0 (cap and body) are then dipped in this solution by applying minimum amount of mould releasing agent. The moulds are then removed at pre determined velocity to give uniform shell thickness.
(5) The mould along with wet solution is then subjected to cool and dry.
(6) The dried shells are then removed from mould and cut to specified length.
(7) The pin with shape as shown in fig.1 is heated up to temperature of 68 deg.C
(8) The pin is pressed by 1.5 mm depth on the dome side of the dried shell and removed immediately.
(9) The embossed shape is seen on the shell.
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Example 2
1) Total 148 gm of HPMC of 4.5 cps and 2910 chemistry is dispersed into 1 liter of de-ionized water (about 90°C).
2) Total 570 gm of HPMC of 1, 00,000 cps and 2208 chemistry is dispersed into 1 liter of de-ionized water (about 90°C).
3) Both the solutions are kept under stirring for 12 hrs to complete hydration.
4) Both the solutions are then mixed under constant stirring in the ratio of 10:1 to make the volume to 1 liter. The solution temperature is then maintained at 78.5°C.
5) To the mixed solution, 250 ml water is added.
6) Capsule forming mould of size 0 (cap and body) are then dipped in this solution by applying minimum amount of mould releasing agent. The moulds are then removed at pre determined velocity to give uniform shell thickness.
7) The moulds along with wet solution are then subjected to cool to solublise and viscosity rise on mould. The set mass is the subjected to dry.
8) The dried shells are then removed from mould and cut to specified length,
9) The pin with shape as shown in fig.2 is heated up to temperature of 75 deg C.
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10)The pin is pressed by 1.5 mm depth on the dome side of the dried shell and removed immediately.
11 )The embossed shape is seen on the shell.
Example 3
1) Total 270 gm of gelatin dispersed into 1 liter of de-ionized water (about 90°C).
2) Total 2 gm of sodium lauryl sulphate is added in the solution made in 1 above.
3) The solution is kept under stirring for 4 to make complete solution. The solution is then cooled to 50 deg C.
4) Capsule forming mould of size 0 (cap and body) are then dipped in this solution by applying minimum amount of mould releasing agent. The moulds are then removed at pre determined velocity to give uniform shell thickness.
5) The moulds along with wet solution are then subjected to cool and viscosity rise on mould. The set mass is the subjected to dry.
6) The dried shells are then removed from mould and cut to specified length.
7) The pin with shape as shown in fig.3 is heated up to temperature of 62 deg C.
8) The pin is pressed by 1.2 mm depth on the dome side of the dried shell and removed immediately.
9) The embossed shape is seen on the shell.
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Example 4
1) Total 270 gm of gelatin dispersed into 1 liter of de-ionized water (about 90°C).
2) Total 2 gm of sodium lauryl sulphate is added in the solution made in 1 above.
3) The solution is kept under stirring for 4 to make complete solution. The solution is then cooled to 50 deg C.
4) Capsule forming moulds are specially made as shown in fig.4
5) Capsule forming mould of size 0 (cap and body) are then dipped in this solution by applying minimum amount of mould releasing agent. The moulds are then removed at pre determined velocity to give uniform shell thickness.
6) The moulds along with wet solution are then subjected to cool and viscosity rise on mould. The set mass is the subjected to dry.
7) The dried shells are then removed from mould and cut to specified length.
Example 5
(1) 0.4 gm of potassium chloride is dissolved in 350 ml of distilled water (about 80°C). Total 100 gm of HPMC of 4.5 cps and 2910 chemistry is dispersed into this water (about 80°C). The temperature of HPMC dispersion is cooled down at about 25°C
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and HPMC is completely dissolved. And then the HPMC solution is heated at about44°C.
(2) 0.65 gm of carrageenan is dissolved into 49.2 ml of water (about 40°C).
(3) Carrageenan solution is added into HPMC solution keeping the temperature at 44°C.
(4) Capsule forming moulds are made as shown in fig 5.
(5) Capsule forming mould of size 0 (cap and body) are then dipped in this solution by applying minimum amount of mould releasing agent. The moulds are then removed at pre determined velocity to give uniform shell thickness.
(6) The mould along with wet solution is then subjected to cool and dry.
(7) The dried shells are then removed from mould and cut to specified length.
Evaluation
Visual observation of embossed surface
The shells were observed for uniformity of emboss and tiny bubble within the embossed area.
Visual observation of embossed surface

Capsules of example Observation of emboss Tiny bubble in emboss
Example 1 (improved) Uniform look No bubbles
Example 2 (improved) Uniform look No bubbles
Example 3 (improved) Uniform look No bubbles
Example 4 ( prior art) Non-uniform look Bubbles seen
Example 5 ( prior art) Non-uniform look Bubbles seen
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Accumulation of mould releasing agents
The shells were filled with fine powder of (Kindly mention) The colour change was observed.
Colour change of formulation

Capsules of example Observation of colour in emboss
Example 1 (improved) No change
Example 2 (improved) No change
Example 3 (improved) No change
Example 4 ( prior art) Change in colour
Example 5 ( prior art) . No change
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WE CLAIM
1. An improved process for manufacturing of embossed hard capsules from water-soluble polymers comprising the steps of;
(a) Dispersing the polymer in hot de-Ionized water at temperature above 60°C to make complete solution or suspension;
(b) applying minimum amount of mould releasing agent to the dipping moulds.
(c) dipping the capsule forming mould in the solution of temperature between 35°C to 80°C more preferably the dipping solution temperature should be 45 to 55 deg C;
(c) removing the mould along with wet mass around it at a pre determined
velocity so as to get uniform film distribution;
(g) allowing the wet mass to cool for viscosity to rise due to solublisation /
gellation;
(h) allowing the mass to dry, stripping the shell from mould and cutting it to
specified length.
(i) pre-making the metal pins of appropriate artwork in reverse direction.
(j) heating the pins to appropriate temperatures
(k) pressing the said preheated embossed pins on the preformed shells to form
the emboss by effect of thermoforming.
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2. An improved process as claimed in claim 1 wherein the water-soluble polymers are selected from gelatin, hydroxy propyl methyl cellulose, pullulan or any other polymer having ability for form strong, flexible, clear and water soluble film.
3. An improved process as claimed in claim 2 wherein the water-soluble polymers are preferably HPMC.
4. An improved process as claimed in claims 1 to 3 above wherein the process of emboss formation is by thermoforming process.

5. An improved process as claimed in claims 1 to 4 above wherein the metal pins are heated to temperature ranging between 45 to 150 deg C, more preferably the temperature is maintained between 60 to 80 deg C.
6. An improved process as claimed claims 1 to 5 above wherein the preheated embossed pins are then pressed on the preformed shells by 0.05 to 5.0 mm depth, more preferably the depth is maintained between 1.0 to 2.0 mm.
7. An improved process as claimed in claims 1 to 6 above wherein the predetermined velocity is in the range of 2 mm/sec to 25mm/sec.
8. An improved process as claimed in the above claims and as herein described with reference to the examples of the specification.