FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
PROVISIONAL SPECIFICATIONS
" ENVIRONMENTALLY STABLE CAPSULES"
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 following specification describes the nature of the invention


Field of the Invention.
Present invention relates to an improved process for manufacturing of Hard capsules from water-soluble cellulose derivatives of low viscosity grade. More particularly present invention relates to an improved process for manufacturing consistent capsule shells of uniform dimension from water-soluble cellulose derivatives of low viscosity grade and which does not loose dimensions such as diameter, weight, wall thickness etc. when exposed to adverse climatic conditions.
Prior Art.
Hard capsules made from Gelatin as well as water-soluble cellulose derivatives is known for years. IT was known that the capsules made from gelatin requires highly controlled conditions during transportation and storage. If this is ignored Gelatin capsules lose dimensions and lead to poor machine performance. The researchers were investigating these disadvantages related with hypromellose capsules.
The researchers were examining various mixture of several grade of hypromellose. From the sincere results of the experiments, The researchers found completely new and novel results. Namely, if the capsules are manufactured with close dimensional tolerance control and moisture kept in a specific range, the capsules retain its dimensions in adverse climatic conditions and give very good filling machine performance.
Summary of the Invention.
The object of the present invention aims at developing an improved process to manufacture hard capsules from water-soluble cellulose derivatives of low viscosity grade.


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It is also the object of the present invention to overcome the drawbacks and disadvantage of the Gelatin capsules such as stringent control on atmospheric conditions during storage and transportation.
The present invention also provides the importance of degree of substitution of Hydroxy-propyl content (HP content) and Methoxy content (MP content) to viscosity rise. The Hp content should be strictly between 9.5% to 12.0 % & Mp content should be within 28% to 30%. The substitution complying to the above norm leads to lower viscosity raise over period of time.
The present invention also provides the imported process for manufacturing of hard capsules from water-soluble cellulose derivatives of low viscosity grade, comprising of the steps of dispersing the water soluble cellulose derivatives of low viscosity grade (of the said degree of substitution) in the hot water, cooling the said dispersion to effect the dissolution of the water soluble cellulose derivatives of low viscosity grade, adding and dissolving the gelling agent in the solution, diluting the solution to the desired viscosity , holding the solution to mature.
It is observed that the viscosity remains stable and does not increase. This stable viscosity results to uniform weights leading to uniformity in overall shell thickness required for better machine-ability.
The solution is maintained between 25 to 45 deg. C. Capsule forming pins are inserted in a predetermined sequence of different velocities while dipping as well as withdrawal so as to pick-up correct mass of solution uniformly and to get adequate strengths at different sections of the shell. The wet pins are then subjected to different temperatures ranging from 20 to 45 deg. C so as to dry the solution to get converted in strong and rigid film. The drying should be carefully done to avoid capsule defects such as starred ends , wrinkles , chipped shells etc. The drying should be done till the moisture of the shells falls between 4.5 to 5.5 %. ,

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It is also observed that if the shells are produced by the process described above exhibits excellent resistance to thermal shocks generally received by capsules due to varying climatic conditions all over the world. The shells does not loose the dimensions and work perfectly on any kind of filling machine without machine stoppage even when exposed to temperatures of 50 deg C.
Dated this 11th day of June, 2008.

M.S.KHADILKAR (Agent for the Applicant)
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