Description:FIELD OF THE INVENTION:
The present invention relates to a process of manufacturing capsules. More particularly, the present invention relates to the process of manufacturing capsules by mixing the aggregated ingredients such as Bacoppa Monnieri Extract, Rhodolia Rosea Extract, and L CARNOSINE.

BACKGROUND OF THE INVENTION:
Tablets or capsules are prepared by forcing particles into close proximity to each other by powder compression, which enables the particles to cohere into a porous, solid specimen of defined geometry. The compression takes place in a die by the action of two punches, the lower and the upper, by which the compressive force is applied. Powder compression is defined as the reduction in volume of a powder owing to the application of a force. Because of the increased proximity of particle surfaces accomplished during compression, bonds are formed between particles which provide coherence to the powder, i.e., a compact is formed. Compaction is defined as the formation of a solid specimen of defined geometry by powder compression.
OBJECT OF THE INVENTION:
The primary objective of the present invention is to disclose a process of manufacturing capsules.

Another primary objective of the present invention is to disclose the process wherein granules are weight equivalent to a required weight and is a mixture of aggregated ingredients which are: glycine, alpha lipoic acid, DHA, ginko biloba, ginserg, green tea extracts, saffron, wherein, the said granule formed by mixing of aggregated ingredients is characterized by: Bacoppa Monnieri Extract, Rhodolia Rosea Extract, and L CARNOSINE

Other objects and advantages of the present invention will become apparent from the following description taken in connection with the accompanying drawings, wherein, by way of illustration and example, the aspects of the present invention are disclosed.
SUMMARY OF THE INVENTION:
In accordance with the present invention a process for manufacturing of capsules is disclosed, comprising the steps of: using, a capsule forming machine; weighing, granules equivalent to a required weight and is a mixture of aggregated ingredients which are: glycine, alpha lipoic acid, DHA, ginko biloba, ginserg, green tea extracts, saffron, wherein, the said granule formed by mixing of aggregated ingredients is characterized by: Rhodolia Rosea Extract; L CARNOSINE; and Bacoppa Monnieri Extract; filling, the said granules into a die cavity; applying, optimum pressure on upper punch so as to granules gets compressed; and ejecting, the prepared capsule for hardness test.
Other objects and advantages of the present invention will become apparent from the following description taken in connection with the accompanying drawings, wherein, by way of illustration and example, the aspects of the present invention are disclosed.
DETAILED DESCRIPTION:
The following description describes various features and functions of the disclosed device and methods with reference to the accompanying figures. In the figures, similar symbols identify similar components, unless context dictates otherwise. The illustrative aspects described herein are not meant to be limiting. It may be readily understood that certain aspects of the disclosed system, method and apparatus can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein.
These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and claims or may be learned by the practice of the invention as set forth hereinafter.
Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
The terms and words used in the following description and claims are not limited to the bibliographical meanings, but, are merely used to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention.
It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.
In accordance with the present invention, the procedure which is used for the manufacturing of tibeto capsule are as follows:
i. Weigh granules equivalent to 1.2gm of granules
ii. Check setting for the tablet machine.
iii. Fill weighed granules into the die cavity.
iv. Apply optimum pressure on upper punch so as to granules gets compressed.
v. After compression eject the prepared tablet and subjected to hardness test.
vi. If tablet have sufficient hardness then repeat the procedure to prepare next tablet.
Calculation for weight of granules equivalent to 1.2gm

Quantity
Quantity given Given in 20
SR. NO. INGREDIENTS in one tablet Tablet
1 L CARNOSINE 200mg 4gm
2 GLYCINE 150mg 3gm
3 ALPHA LIPOIC ACID 100mg 2gm
4 DHA 150mg 3gm
5 GINKO BILOBA 60mg 1.2gm
6 GINSERG 42.5mg 0.85gm
BACOPA MONNIERI
7 EXTRACT 1000mg 20gm
8 GREEN TEA EXTRACT 80mg 1.6gm
9 RHODIOLA ROSEA EXTRACT 400mg 8gm
10 SAFFRON 5mg 0.1gm
11 MAIZE STARCH 0.48gm
12 PURIFIED TALC 0.12gm
13 MPS 0.024gm
14 PPS 0.012gm
15 SSG 0.1992gm
16 AEROSIL 0.04008gm
17 CALCIUM CARBONATE 0.24gm
18 GELATIN 0.12gm

Further, various parameters of the capsules such as thickness, diameter, weight, friability, hardness and disintegration test are determined and evaluated in order to check whether the capsules formed are as per standard industry or not. The determination of parameters are explained with suitable example as follow:
Example 1. Determination of thickness and diameter of the capsules:
It is necessary that the capsule thickness should lies within 5% or less of a standard value because small variation in capsule thickness and diameter significantly affects hardness and dissolution profile of capsule. The capsule diameter and thickness is measured by using vernier calliper. Least count of measuring instrument is the ratio of smallest division on main scale and total number of divisions on vernier scale or thimble scale.
The steps involving in the measuring of thickness of the capsules are as follows:
• determine the least count of vernier calliper and calculate least count by dividing smallest division on main scale by total number of divisions on vernier scale.
• place a capsule between measuring jaws and record main scale and vernier scale reading.
• measure thickness for ten capsules.
• complete the calculations and calculate average thickness for capsule.
• calculate 5 % deviation from average thickness.
• calculate range and check whether individual thickness of capsule lies in it.
Calculations:
1. Percent deviation:

Percent deviation = 5 x average thickness/100

2. Upper limit:

UL = Avg thickness + Percent deviation

3. Lower limit:

LL = Avg thickness - Percent deviation

4. Thickness range:

Thickness range = (LL to UL)
Example 2. Determination of hardness of a given capsule:
Hardness is a property which is dependent on density and porosity of the material on one hand and pressure of the compression on the other. The resistance of capsule to chipping, abrasion or breakage under condition of storage, transportation and handling factor before use depends on hardness of capsule. Hardness adjustments are made throughout capsule run to determine the need for pressure adjustment for capsulating machine. If capsule is too hard, it will into disintegrate, will require period of time or meet the dissolution specification. If too soft, it will not withstand during subsequent processing such as coating, packaging and transportation. The harness of the capsule is determined by Monsanto hardness tester.
The steps involving in the measuring of harness of the capsules are as follows:
i. place the capsule diametrically on fixed anvil of the monsanto hardness tester.
ii. rotate the top screw of the tester so as to capsule holds between fixed and moving anvil of tester.
iii. adjust the scale suitably to zero.
iv. again, rotate top screw of the tester so as to pressure gets applied on capsule.
v. continue the rotation of screw till capsules breaks.
vi. at this stage, record the reading on scale.
vii. repeat the procedure for next capsule.
Example 3. Determination of weight variation of given capsules:
The test ensures that all the capsules in a batch are of same potency, within reasonable limits. Weight variation may basically occur due to the depth of the die cavity, bulk density of granules or powder, uniformity of particulate flow, wide variation in granule size and improper lubrication. Even with a proper granulation having uniform flow, a volume fill is not as accurate as a fill based on weight. Therefore, capsule weight variations must fall within certain specifications established by the Fssai. Each capsule in a batch should be uniform in weight and the weight variation if any, should be generally within + - 10% for capsules weighing 80 mg or less, + - 7.5% for capsules weighing more than 80 mg and up to 250 mg, and + - 5 % for capsules weighing 250mg or more. Hence, all finished batches, 20 capsules are weighed collectively and individually. From the collective weight average weight per capsule is calculated. The weights of individual capsules are the compared to ascertain whether they are within permissible limits or not. Weight of the capsule is done using a weighing balance.
The steps involving in the measuring of weight variation of the capsules are as follows:
i. take approx. 20 capsules.
ii. weigh individually capsules and record weight in observation table.
iii. again, take weight of 20 capsules collectively.
iv. from collective weight calculate average weight per capsule.
v. as weight of individual capsule is more than 250 mg so consider 5% variation.
vi. calculate 5% variation from average value.
vii. calculate upper limit and lower limit.
viii. compare weights of individual capsules to ascertain whether they are within permissible limits or not.

Calculations:
1. Average weight per capsule:

Average weight per capsule = Collective weight of 20 capsule / 20

2. 5 % deviation from average weight:
Percent deviation = 5 x average weight of capsule /100

3. Upper limit:

Upper limit = Average weight per capsule + 5 % deviation from average

4. Lower limit:

Lower limit = Average weight per capsule + 5 % deviation from average

When the above calculations were measured while analysing the parameters of the capsules formed using the machine of the present invention, it was found that the average weight of the capsule was 1203.95mg and 5 % deviation from average is 60.197 mg. Therefore, the weight of individual capsule lies within permissible limits and the produced capsules using the machine of the present invention comply with FCC standards.
Example 4. Determination of friability of given capsules:
This test is designed to measure the ability of the capsule to withstand abrasion in packaging, handling and transportation. Friability generally refers to loss in weight of capsules in the containers due to removal of fine particles from their surfaces. Test is performed to assess the effect of friction and shock which may often cause capsules to chip, cap or break. It generally reflects poor cohesion of capsule ingredients. The equipment most commonly used for friability test is the Roche Friabilator. It consists of a circular plastic chamber divided into 2 or 3 compartments. This chamber rotates at 25 rpm and drops the capsules from a height of 15cm with each revolution. For capsule with unit mass equal to or less than 650mg take a sample of whole capsule corresponding to 6.5g and for a capsule with unit mass of more than 650mg take sample of 10 whole capsules. Pre-weighed capsule are placed in the apparatus and the friabilator is operated for 100 revolutions and the capsule are weighed again. The difference in the two weights represents friability. The weight loss should not be more than one percent.
The steps involving in the measuring of friability of the capsules are as follows:
i. collect capsules, dedust and check individual weight.
ii. if weight of one capsule less than 1.3 mg then take a sample of whole capsule corresponding to weigh 1.3 g. record the weight of capsules as w0.
iii. remove capsule from friabilator and clean properly.
iv. place the capsules in drum and fix it to friabilator.
v. operate the friabilator for 100 revolutions.
vi. once again remove drum and dedust capsules
vii. check capsules for capping, lamination and chipping.
viii. again, take weight for capsules and record it as w1.
ix. calculate the percent friability.

When the above calculations were measured while analysing the parameters of the capsules formed using the machine of the present invention, it was found that the weight of capsules before friability test (W0)1.3 g and Weight of capsules after friability test is (W1)1.27 g and the Friability of given capsule was found to be 2.307%.
Calculations:
Friability:
Percent friability = [W0-W1] x 100/W0
Example 5. Determination of disintegration test of given capsules:
Disintegration is defined as the state in which any residue of the capsules, except fragments of insoluble coating remaining on the screen of the test apparatus consists of a soft mass having no palpably firm, unmoistened core.
This disintegration test is provided to determine whether capsules disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. The apparatus consists of a basket rack assembly supporting six glass tubes. These tubes are held vertically by two superimposed transparent plastic plates with six holes having same diameter as the tubes. Woven wire gauge made os stainless steel is attached to the underside of the lower plate. The upper and the lower plates are held in position by vertical metal rods at the periphery and a metal rod in the centre of the upper plate for attachment to mechanical device. The assembly should be raised and lowered between 28 to 32 times per minute in the liquid at 37oC.
The steps involving in the determination of disintegration test of the capsules are as follows:
i. remove basket assembly from the apparatus.
ii. place required quantity of water (800 to 900 ml) into beaker provided with apparatus.
iii. place beaker on its position and switch on the temperature knob to attain temperature of medium to 37oc.
iv. add one capsule in each tube of basket assembly and put discs if necessary.
v. suspend assembly in liquid and operate equipment for 15 minutes.
vi. observe continuously each capsule till disintegration. record disintegration time for all capsules.
vii. at the end of 15 minutes remove basket assembly and observe each tube for any residue of capsule.

When the above calculations were measured while analysing the parameters of the capsules formed using the machine of the present invention, it was found that the disintegration time of given capsule was found to be 14.86min.
, Claims:1. A process for manufacturing of capsules, comprising the steps of:
i. using, a capsule forming machine;
ii. weighing, granules equivalent to a required weight and is a mixture of aggregated ingredients which are: glycine, alpha lipoic acid, DHA, ginko biloba, ginserg, green tea extracts, saffron, wherein, the said granule formed by mixing of aggregated ingredients is characterized by: Bacoppa Monnieri Extract, Rhodolia Rosea Extract; and L CARNOSINE;
iii. filling, the said granules into a die cavity;
iv. applying, optimum pressure on upper punch so as to granules gets compressed;
v. ejecting, the prepared capsule for hardness test.

2. The process as claimed in claim 1, further comprising the steps of:
a. evaluating, thickness and diameter of capsules by using a vernier calliper;
b. determining, hardness of the said capsules by using a hardness tester;
c. determining, weight variation test for the said capsules;
d. determining, friability of the said capsules by using a Friability Test Apparatus; and
e. performing, disintegration test for capsules.

3. The process as claimed in claim 1, wherein the quantity of mixed aggregated ingredients in one capsule comprises of:
a. 200 mg of L CARNOSINE;
b. 150 mg of glycine;
c. 100 mg of alpha lipoic acid;
d. 150 mg of DHA
e. 60 mg of ginko biloba
f. 42.5 mg of ginserg
g. 1000 mg of Bacoppa Monnieri Extract;
h. 80 mg of green tea extracts;
i. 400 mg of Rhodolia Rosea Extract; and
j. 5 mg of saffron.