DESC:The present invention relates to the field of disintegrating oral film. More particularly it relates to the process of preparing Senna oral disintegrating film.

BACKGROUND OF THE INVENTION

Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time-consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for existing drugs.

Orally disintegrating films (ODFs) are very eminent dosage forms among pediatrics, geriatrics and oral cancer patients and all those patients who have practical difficulty in swallowing. These fast-disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This drug delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active ingredient (API) within seconds.

There are several other patents which discuss about laxative compositions. JP5871830B2 tilted “Polyethylene glycol colon laxative composition” disclose about colonic laxative formulations comprising at least one polyethylene glycol and the use of these formulations. In a particular aspect of the invention, the formulation contains substantially polyethylene glycol 8000, which helps improve patient tolerance and endoscopic insertion. The formulation can be administered in a variety of dosage forms, including but not limited to solid or liquid dosage forms. In certain embodiments, the composition is useful for thoroughly washing the colon. In other embodiments, the composition is useful as a laxative.

Senna is a natural medicine derived from the senna plant. Senna contains sennosides which acts as a stimulant laxative. It works by irritating and stimulating intestinal cells, producing contractions in intestines, water influx to the intestines and bowel movement.

Another Patent No. CA2668245C tilted “Improved laxative composition and method” discuss about an improved laxative composition is provided having efficacy with reduced negative side-effects. The laxative composition is also provided with agents that promote healthy intestinal and liver function, reduce carbohydrate absorption and have antioxidant capacity. A method is also provided for reducing the negative side-effects associated with Anthranoid-based laxative compositions. A method is further provided for increasing the efficacy and/or duration of effect of Anthranoid-based laxative compositions.

JP4684334B2 tilted “Laxative composition” novel laxative composition useful for reducing or preventing constipation in human constipation patients and also for intestinal lavage. Prostaglandins (hereinafter referred to as PGs) are names of a group of fatty acids having various physiological activities and contained in human and animal tissues and organs. PGs essentially contain a prostanoic acid skeleton of the formula: Some synthetic products contain some modifications in the above skeleton. PGs are classified into several types according to structure and five-membered ring substituents.
The present invention implements a process of preparing senna oral disintegrating film for laxative purpose. Hence this ready to dissolve film is convenient to consume and presents to be the best alternative to oral tablets, extended-release tablets, chewable tablet, liquid and concentrated oral drops.

SUMMARY OF THE INVENTION

The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.

The main objective of the present invention is a process to prepare senna oral disintegrating film.

Another objective of the present invention is senna oral disintegrating film helps to manage constipation.

Further objective of the present invention is by taking senna oral disintegrating film helps to remove fecal matter from the intestines due to its laxative property by promoting bowel movement and promoting the passage of stool from the body.
In one aspect of the present invention, is to provide senna oral disintegrating film stimulates the transport of water and electrolytes which increases intestinal movements. This helps in further cleaning of the intestines for Colonoscopy.

In yet another aspect of the present invention, to help loosen the stool and speed up the bowel movement. It also promotes easy excretion of the stool.

The features and advantages of the present proposed system will become more apparent from the following detailed description along with the accompanying figures, which forms a part of this application by reference numerals:

REFERENCE NUMERALS
Weigh required quantity of 13% HPMC solution in a container (100).

Add Weighed quantity of Sucralose to step-1 and stir for 5min (101).

Add Weighed quantity of maltodextrin to step-2 and stir for 5min (102).

Add Weighed quantity of glycerin to step-3 and stir for 5min (103).

Add Weighed quantity of Di basic Calcium Phosphate to step-4 and stir for 5min (104).

Add Weighed quantity of Peppermint Flavour to step-5 and stir for 5min (105).

Add Weighed quantity of Senna Extract to step-6 and stir for 10min (106).

Add Weighed quantity of Formulation water to step-7 and stir for 15min (107).

Above step wet slurry subjected to vacuum degassing (108).

Coating of above wet slurry at process parameters of Coating Thickness- 400 - 500µ, Drying Temperature - 95±3°c, Drying Time- 19minutes (109).

Post drying, slit the film into 25mm x 30mm (width x Length) to get the desired weight (110).

DETAILED DESCRIPTION OF THE INVENTION

The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.

The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are constructed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.

Senna contains many chemicals called sennosides. Sennosides irritate the lining of the bowel, which causes a laxative effect.

Senna is good for Constipation: Senna helps in managing constipation due to its laxative property. It contains certain constituents that help loosen the stool and speed up the bowel movement. It also promotes easy excretion of the stool.

Senna for Intestine preparation before any surgery or in diagnostic imaging procedures: Senna helps in Intestine/bowel preparation before any diagnostic or surgical procedure like colonoscopy which requires a fecal matter free bowel. It has a laxative property which promotes bowel movement and helps in the easy excretion of stool. Senna also stimulates the transport of water and electrolytes which increases intestinal movements. This helps in further cleaning of the intestines for Colonoscopy.

The function of each ingredient is given below:

In an embodiment of the present invention is a process of preparing senna source oral disintegrating film comprises of the following steps:
S. No. Ingredients Function
1 Senna Extract 60% Active
2 Maltodextrin Film forming Agent
3 Hydroxypropyl Methylcellulose (HPMC) Film forming Agent
4 Glycerol Plasticizer
5 Sucralose Sweetening agent
6 Di basic Calcium Phosphate Anhydrous Diluent
7 Peppermint Flavour Flavouring Agent
8 Purified Water* Vehicle

1) Weigh required quantity of 13% HPMC solution in a container (100).
2) Add Weighed quantity of Sucralose to step-1 and stir for 5min (101).
3) Add Weighed quantity of maltodextrin to step-2 and stir for 5min (102).
4) Add Weighed quantity of glycerin to step-3 and stir for 5min (103).
5) Add Weighed quantity of Di basic Calcium Phosphate to step-4 and stir for 5min (104).
6) Add Weighed quantity of Peppermint Flavour to step-5 and stir for 5min (105).
7) Add Weighed quantity of Senna Extract to step-6 and stir for 10min (106).
8) Add Weighed quantity of Formulation water to step-7 and stir for 15min (107).
9) Above step wet slurry subjected to vacuum degassing (108).
10) Coating of above wet slurry at process parameters of Coating Thickness- 400 - 500µ, Drying Temperature - 95±3°c, Drying Time- 19minutes (109).
11) Post drying, slit the film into 25mm x 30mm (width x Length) to get the desired weight (110).

The composition involved in preparing the senna oral disintegrating film is detailed below in the tabular column:

Senna oral Disintegrating film with 60%
S. No. Ingredients %w/w
1 Senna Extract 60% 17.36
2 Maltodextrin 17.36
3 Hydroxypropyl Methylcellulose (HPMC) 30.55
4 Glycerol 13.89
5 Sucralose 4.17
6 Di basic Calcium Phosphate Anhydrous 5.56
7 Peppermint Flavour 11.11
8 Purified Water* q. s.
Total 100.00

* Water gets evaporated during the coating process and traces of water content will remain in product.

Senna oral Disintegrating film with 20%
S. No. Ingredients %w/w
1 Senna Extract 20% 27.37
2 Maltodextrin 9.12
3 Sucralose 2.92
4 Glycerol 12.41
5 Hydroxypropyl Methylcellulose (HPMC) 30.66
6 Hydroxypropyl Pea starch 7.30
7 Di basic Calcium Phosphate Anhydrous 2.92
8 Peppermint Flavour 7.30
Purified Water* q. s.
Total 100.00

* Water gets evaporated during the coating process and traces of water content will remain in product.

The films were evaluated for disintegration time, folding endurance, water content Assay. The films were subjected to stability study under 40°C ± 2°C and 75% ± 5% RH condition for six months and evaluated above test parameters and results are tabulated.
Example- 1: Results
S. No. Test Parameters Limits Results
Initial 1month 3months 6months
1 Disintegrating time NMT 60sec 16 sec 11 sec 17 sec 18 sec
2 Folding Endurance NLT 10 150 folds 150 folds 150 folds 150 folds
3 Water content NMT 10.00% 5.6 6.5 8.5 8.56
4 Assay NLT 80.00% 99.7 98.9 98.2 97.6

Benefits/Uses:
Senna contains many chemicals called sennosides. Sennosides irritate the lining of the bowel, which causes a laxative effect.
Senna for Constipation: Senna helps in managing constipation due to its laxative property. It contains certain constituents that help loosen the stool and speed up the bowel movement. It also promotes easy excretion of the stool.
Senna for Intestine preparation before any surgery: Senna helps in Intestine/bowel preparation before any diagnostic or surgical procedure like colonoscopy which requires a fecal matter free bowel. It has a laxative property which promotes bowel movement and helps in the easy excretion of stool. Senna also stimulates the transport of water and electrolytes which increases intestinal movements. This helps in further cleaning of the intestines for Colonoscopy.
Manufacturing procedure
1. Weigh required quantity of Purified water in a container.
2. Add Weighed quantity of Sucralose to step-1 and stir for 5min.
3. Add Weighed quantity of maltodextrin to step- 2 and stir for 5min.
4. Add Weighed quantity of glycerin to step-3 and stir for 5min.
5. Add Weighed quantity of Di basic Calcium Phosphate to step-4 and stir for 5min.
6. Add Weighed quantity of Peppermint Flavour to step-5 and stir for 5min.
7. Add Weighed quantity of Senna Extract to step-6 and stir for 10min.
8. Add Weighed quantity of Formulation water to step-7 and stir for 5min.
9. Add required quantity of HPMC powder to step- 8 and stir for 15 min.
10. Above step wet slurry subjected to vacuum degassing.
11. Coating of above wet slurry at process parameters of Coating Thickness- 400 - 500µ, Drying Temperature - 95±3°c, Drying Time- 19minutes.
12. Post drying, slit the film into 25mm x 30mm (width x Length) to get the desired weight.

Throughout this specification various indications have been given as to preferred and alternative embodiments of the invention. It should be understood that it is the appended claims, including all equivalents that are intended to define the spirit and scope of this invention.
,CLAIMS:1. A disintegrating senna composition comprising:
Senna Extract 60% 17.36 %w/w Senna 20% 17.36 %w/w;
Maltodextrin 17.36 %w/w;
Hydroxypropyl Methylcellulose (HPMC) 30.55 %w/w;
Glycerol 13.89 %w/w;
Sucralose 4.17 %w/w;
Di basic Calcium Phosphate Anhydrous 5.56 %w/w;
Peppermint Flavour 11.11%w/w;
Purified Water wherein the said water gets evaporated during the coating process and traces of water content will remain in the resultant composition.
2. A disintegrating senna composition comprising:
Senna 20% 17.36 %w/w;
Maltodextrin 17.36 %w/w;
Hydroxypropyl Methylcellulose (HPMC) 30.55 %w/w;
Glycerol 13.89 %w/w;
Sucralose 4.17 %w/w;
Di basic Calcium Phosphate Anhydrous 5.56 %w/w;
Peppermint Flavour 11.11%w/w;
Purified Water wherein the said water gets evaporated during the coating process and traces of water content will remain in the resultant composition.

3. A process to prepare senna oral disintegrating film comprises of the following steps:
i. Weigh required quantity of 13% HPMC solution in a container (100);
ii. Add Weighed quantity of Sucralose to step-1 and stir for 5min (101);
iii. Add Weighed quantity of maltodextrin to step-2 and stir for 5min (102);
iv. Add Weighed quantity of glycerin to step-3 and stir for 5min (103);
v. Add Weighed quantity of Di basic Calcium Phosphate to step-4 and stir for 5min (104);
vi. Add Weighed quantity of Peppermint Flavour to step-5 and stir for 5min (105);
vii. Add Weighed quantity of Senna Extract to step-6 and stir for 10min (106);
viii. Add Weighed quantity of Formulation water to step-7 and stir for 15min (107);
ix. Above step wet slurry subjected to vacuum degassing (108);
x. Coating of above wet slurry at process parameters of Coating Thickness- 400 - 500µ, Drying Temperature - 95±3°c, Drying Time- 19minutes (109);
xi. Post drying, slit the film into 25mm x 30mm (width x Length) to get the desired weight (110).

4. The system as claimed in claim 1, wherein the peppermint is used as a flavor for senna oral disintegrating film.