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"Novel Combination Of Effervesce Tablet Of Micronised Eggshell & Stabilized Vitamin D3"

Abstract: The present invention provides effervescent immediate release drug compositions comprising combination of Micronised Eggshell & stabilized Vitamin D3, processes for their preparation; and methods of using such compositions as calcium supplement.

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Patent Information

Application #
Filing Date
20 September 2013
Publication Number
28/2015
Publication Type
INA
Invention Field
FOOD
Status
Email
Parent Application

Applicants

1. LADDHA, SACHIN SHYAMSUNDAR
TOWER 4, FLAT 1201, SWASTIK REGALIA, KAVESAR, WAGHBIL, GB ROAD, THANE (W) 400615, MAHARASHTRA, INDIA
2. WAGHULDE, SANDEEP ONKAR
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
3. HANGE, NAGESH PARMESHWAR
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
4. PATIL, NIRANJAN VIJAY
102-B, VEDANT SOCIETY, WAYALE NAGAR, KALYAN (W) MAHARASHTRA
5. PATEL, HIREN MANJI
B-104 BEHIND CHAWL NO.36, NAIDU COLONY, SHREE SIDDHRAMESHWAR MARG, PANT NAGAR, GHATKOPER, MUMBAI- 400075, MAHARASHTRA
6. SIKDAR, MRINAL VIVEKANAND
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
7. SARANGI, MANOJKUMAR
AT/POST. BIRASWARPUR VIA DUKURA DIST: MAYURBHANJ, ODISHA-757075, MAHARASHTRA
8. PATIL, AJIT HASHA
NEAR GANESH TEMPLE, DHAKTA KHANDA, TAL: PANVEL, DIST: RAIGAD-410206, MAHARASHTRA
9. KUMBHAR, AMIT RAMCHANDRA
AT/POST - MASUR, TAL-KARAD, DIST-SATARA, 415106, MAHARASHTRA

Inventors

1. LADDHA, SACHIN SHYAMSUNDAR
TOWER 4, FLAT 1201, SWASTIK REGALIA, KAVESAR, WAGHBIL, GB ROAD, THANE (W) 400615, MAHARASHTRA, INDIA
2. WAGHULDE, SANDEEP ONKAR
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
3. HANGE, NAGESH PARMESHWAR
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
4. PATIL, NIRANJAN VIJAY
102-B, VEDANT SOCIETY, WAYALE NAGAR, KALYAN (W) MAHARASHTRA
5. PATEL, HIREN MANJI
B-104 BEHIND CHAWL NO.36, NAIDU COLONY, SHREE SIDDHRAMESHWAR MARG, PANT NAGAR, GHATKOPER, MUMBAI- 400075, MAHARASHTRA
6. SIKDAR, MRINAL VIVEKANAND
FLAT NO. 303, BLD NO. 14, LAVENDER, AMBIKA RESIDENCY, REGENCY ESTATE, KALYAN-SHIL ROAD, DOMBIVLI (E)-421201, MAHARASHTRA
7. SARANGI, MANOJKUMAR
AT/POST. BIRASWARPUR VIA DUKURA DIST: MAYURBHANJ, ODISHA-757075, MAHARASHTRA
8. PATIL, AJIT HASHA
NEAR GANESH TEMPLE, DHAKTA KHANDA, TAL: PANVEL, DIST: RAIGAD-410206, MAHARASHTRA
9. KUMABHAR, AMIT RAMCHANDRA
AT/POST - MASUR, TAL-KARAD, DIST-SATARA, 415106, MAHARASHTRA

Specification

FORM 2
THE PATENTS ACT 1970
(39 of 1970)
AND
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. TITLE OF THE INVENTION:
"NOVEL COMBINATION OF EFFERVESCE TABLET OF MICRONISED EGGSHELL & STABILIZED VITAMIN D3"
2. APPLICANT (S):
(a) NAME: LADDHA, SACHIN SHYAMSUNDAR
(b)NATIONALITY: Indian
(c) ADDRESS: Tower 4, Flat 1201, Swastik Regalia, Kavesar Waghbil, GB road, Thane (w) 400615, Maharashtra, India.
3. PREAMBLE TO THE DESCRIPTION:
The following specification particularly describes the invention and the manner in which it is to be performed

Field of the invention
The present invention provides effervescent drug compositions comprising combination of micronised Eggshell and stabilized vitamin D3. The effervescent compositions comprise of effervescent agents and other excipients like surfactants, binders, lubricants, and colouring agents. The invention further relates to a process for preparation of the Effervesce tablet
Background of the invention:
The bird egg is a fertilized (or. in the case of some birds [such as chickens] possibly unfertilized) gamete located on the yolk surface and surrounded by albumen, or egg white. The albumen in turn is surrounded by two shell membranes (inner and outer membranes) and then the Eggshell. The chicken Eggshell is 95-97% calcium carbonate crystals, which are stabilized by a protein matrix. Without the protein, the crystal structure would be too brittle to keep its form and the organic matrix is thought to have a role in deposition of calcium during the mineralization process. The structure and composition of the avian Eggshell serves to protect the egg against damage and microbial contamination, prevention of desiccation, regulation of gas and water exchange for the growing embryo, and provides calcium for embryogenesis. Eggshell formation requires gram amounts of calcium being deposited within hours, which must be supplied via the hen's diet.
Eggshells are mostly composed of calcium, but they also contain at least 27 trace micro-elements. The calcium contained in Eggshells is up to 90% absorbable by our bodies. This believes that it is a much better, not to mention more natural source of calcium for our bodies than limestone sources. Eggshell is covered with as many as 17,000 tiny pores. Eggshell is made almost entirely of calcium carbonate (CaC03) crystals. It is a semipermeable membrane, which means that air and moisture can pass through its pores. . The shell also has a thin outermost coating called the bloom or cuticle that helps keep out

bacteria and dust. The Eggshell is approximately 95% calcium carbonate crystals, which are stabilized by a protein matrix.
Calcium is essential for maintenance of the nutritional integrity of nervous, muscular and skeletal system, cell membranes and capillary permeability. Calcium carbonate is a better bioavailable calcium source compared to other calcium salt.
Vitamin D3 (Cholecalciferol) is a secosterol, which is a natural precursor of the calcium-regulating hormone calcitriol (1,25 dihydroxyvitamin D3). Vitamin D3 is a white, crystalline, odorless powder. It is practically insoluble in water, freely soluble in usual organic solvents, and slightly soluble in vegetable oils. The principal action of calcitriol is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion.
Vitamin D is required for normal bone formation. Insufficiency of vitamin D is developed when sunlight exposure and dietary intake are inadequate. The vitamin D insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture. In severe cases, vitamin D deficiency results in more severe hyperparathyroidism, hypophosphatemia, proximal muscle weakness, bone pain and osteomalacia.
There are many types of calcium supplements available which include calcium citrate, calcium carbonate, calcium phosphate, calcium lactate, calcium gluconate, calcium malate and calcium citrate malate. Calcium carbonate is comparitively more soluble in water than other calcium supplements.
The effectiveness of calcium source depends upon elemental calcium, absorbable calcium and solubility at neutral pH. Elemental calcium is the amount of calcium available to the body for absorption, and absorbable calcium refers to the percentage of elemental calcium that can be absorbed by the body. Calcium carbonate provides about 40% elemental calcium and about 26% of it is absorbable. Calcium citrate provides about 22%

elemental calcium and about 24% of it is absorbable. Calcium carbonate is the most effective source of calcium as its solubility at neutral pH and percentage of absorbable calcium is more compared to other calcium supplements.
Pharmaceuticals intended for oral administration are provided in solid form as tablets, capsules, pills, or granules. Tablets are swallowed whole, chewed in the mouth, or dissolved in the oral cavity. However, patients at the extremes of age, such as children and the elderly, often experience difficulty in swallowing solid oral dosages forms. For these patients the drugs are mostly provided in liquid dosage forms such as solutions, emulsions and suspensions.
The value of effervescent tablets has been recognized for many years as a very effective dosage form that permits the active ingredient(s) to be quickly utilized by the patient's body. Effervescent tablets are often employed in the administration of pharmaceuticals where it is impractical to provide a tablet for swallowing whole, for instance with paediatric patients. This is of particular value where rapid availability of the active ingredients is desired. On the other hand, the need for solid pharmaceutical forms capable of making the medicament available within a short time from the administration is particularly felt even for those patients who do not have any swallowing problems.
Children, older persons, and many other persons have trouble swallowing whole tablets and even capsules. Therefore, in cases where the dosage to be administered cannot be made into a very small tablet or capsule, it is desirable to provide the medicine either in liquid form or in a effervescent solid form, in addition to the tablet or capsule that is designed to be swallowed whole. Even where the medicine can be formulated as a liquid, it is desirable also to be able to provide an effervescent tablet because of added convenience versus carrying a supply of liquid medicine. Effervescent tablets are more easily transported than liquid medication because no water is added until it's ready to use. Effervescent tablets have major advantage that the drug product is already in solution at the time it is consumed. Thus, the absorption is faster and more complete. Drugs

delivered using effervescent technology have predictable and reproducible pharmacokinetic profiles that are much more consistent than tablets or capsules.
Effervescence is achieved by including an acid, for example, citric acid and/or tartaric acid, and an effervescing alkali, for example sodium bicarbonate, potassium bicarbonate and/or calcium carbonate, in the formula. In the presence of traces of water, these ingredients react,. forming bubbles of carbon dioxide and liberating more water that further promotes the reaction. Depending on the nature of the active ingredient(s), which may be either soluble in water or are converted to the sodium salt(s) which are then dissolved, all ingredients of effervescent sub-lingual tablets are typically dissolved before ingestion. Effervescent tablets dissolve in water resulting in active ingredient already dissolved or dispersed in water is in a highly bio-available form. Carbon dioxide released during effervescence helps to mask the bitter taste without the need to add sweetening agents.
The chicken Eggshell comprises calcified shell and shell membranes including inner and outer membranes. These membranes retain albumen and prevent penetration of bacteria. Shell membranes are also essential for the formation of Eggshell. The organic matter of Eggshell and shell membranes contain proteins as major constituents with small amounts of carbohydrates and lipids (Burley and Vadehra, 1989). Bronsch and Diamantstein (1965) analyzed uronic acid in Eggshells and reported a significant correlation between the uronic acid content and the breaking strength of the shell. Uronic acid is a constituent sugar of glycosaminoglycan. The study has shown that the organic matter of Eggshell contains two glycosaminoglycans including hyaluronic acid and chondroitin sulfate-dermatan sulfate copolymer. Sialic acid is another carbohydrate found in Eggshell membranes (Itoh et al., 1990; Nakano et al, 1994). However, little is known about the difference in concentrations of sialic acid between the inner and outer Eggshell membranes. There is also limited information available concerning variations in nitrogen concentrations and amino acid composition among the organic matter of Eggshell and shell membranes. Eggshell and shell membranes are non-edible by-products with little saleable value.

Journal of chemical ecology, volume 31, issue 10, pages 2391-401, Sexion et al., 2005; discloses Micronised Eggshell composition of squamate reptiles; relationship between Eggshell permeability and amino acid distribution.
British poultry science, volume; 40, issue 2, pages 240-52, 1999, discloses the structure of Eggshell matrix composition of verious domesticated bird species were compared to gain insight into the universality of the Eggshell mineralisation process.
US 6509326 discloses nutritional mineral supplements that employ specific calcium salts of mixtures of citric and malic acids, and vitamin D. Estrogen can also be used in conjunction with any of these supplements. These nutritional mineral supplements can be added to foods and beverages, and are useful for increasing bone growth and treating age-related bone loss. The supplement is administered in the form of liquid dosage form such as aqueous solutions, emulsions, suspensions and/or suspensions reconstituted from non-effervescent granules and effervescent preparations reconstituted from effervescent granules.
US 5612026 discloses drink mix compositions useful for reducing serum cholesterol levels containing an anion exchange resin, xanthan gum, and an edible water-soluble salt at a level that reduces gelation rate of the drink mix compositions in an aqueous solution. The preferred form of compositions is a dry powder in bulk or unit dose form which readily mixes and disperses in a liquid, wherein calcium carbonate is used as the edible water-soluble salt to reduce gellation rate.
US 5888540 discloses a soft gelatin capsule with a fill comprising a hydrogel material including alginic acid or metal alginates (e.g. sodium alginate); a gas generating agent such as calcium carbonate along with a bicarbonate; and an oil-based vehicle. The soft gelatin capsule, upon contact with an acidic aqueous medium, breaks up, disperses or dissolves, and the fill reacts to form a foam.

US 5128374 teaches the method of building bone in humans and animals for the treatment of osteoporosis and related disorders, by administtration of certain calcium salts. Calcium carbonate_is preferably administered in an oral dosage form, containing pharmaceutically acceptable carriers and excipients.
However there are no reports on effervescent tablets which contain a combination of micronised Eggshell and stabilized vitamin D3,
The present invention relates to compositions of micronised Eggshell and stabilized vitamin D3 in the form of effervescent tablet. The present invention relates to pharmaceutical compositions comprising such combination; processes for their preparation; and methods of using such compositions as calcium supplement.
Summary of the invention
One aspect of the present invention is to provide compositions comprising of micronised Eggshell along with stabilized vitamin D3 in the form of effervescent tablet capable of dissolving in water. Further invention relates to provide effervescent compositions of Eggshell and stabilized vitamin D3 which can deliver a substantial amount of the actives immediately when dissolved in water.
Another aspect of the invention is to provide a process for the preparation of pharmaceutical compositions comprising micronised Eggshell along with stabilized vitamin D3 in a single dosage unit comprising the steps of
a) granulating Eggshell powder with surfactants
b) granulating Vitamin D3, buffering agents with moisture barrier agents to avoid pre-moisture contact of the actives
c) granulating carbonates avoids pre-moistening
d) Lubricating with other excipients and final compression of the tablet.

Detailed description of the invention:
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated.
The process of using Eggshells for a source of calcium is simple. Simply boil organic Eggshells in hot wate ten minutes. This is to be sure that any pathogens contained within the shell are removed. Once you have boiling process, remove the shells and allow them to air dry. After drying, break the shell pieces down to small bits to fit into a coffee grinder, then grind into a fine powder. Store the resulting powder in a glass jar and from light if possible. One medium Eggshell should contain about 1 teaspoon of powder, and about 750mg of elemental calcium. It is best to use organic Eggshells since many non organic farmers feed their chicken antibiotics.
It is suggested that most people should take at least 400mg of calcium per day to supplement next to their sources, which equates to about half a teaspoon of Eggshell sourced calcium. Do not exceed more than 5 calcium at one time since your body is unable to process that much calcium at once. If you require more than of calcium be sure to split it up throughout the day to make sure as much as a possible is being absorbed, above, it would be best to take the calcium with some other nutrients such as magnesium, zinc, vitamin D3. Kl, vitamin K2, strontium, and boron. At the very least take a multivitamin along with some added magnesium out in the sun for at least 15 minutes a day if light skinned, or 30 minutes a day if dark skinned. It should also be noted that our bones are comprised of much more than calcium. They contain many trace minerals, so it would also be a good idea to supplement with a trace mineral supplement. A few good food sources of trace minerals are maca, spirulina, chlorella, kelp, dulse, and mushrooms.
Eggshell containing calcium carbonate is used in dietary supplements when the amount of calcium taken in the diet is not enough; and is also used as an antacid to relieve heartburn, acid indigestion and stomach upset. Calcium carbonate is one of the widely

accepted antacid which can offer quick relief from acidity. Calcium carbonate is micronised and particles are less than or equal to 50 microns. The amount of calcium citrate malate in the formulation is ranging from 2 % to 25 % w/v of equivalent calcium by weight of total formulation.
Vitamin D3 is a white, crystalline, odorless powder. It is used to increase intestinal absorption of calcium ion and regulate serum calcium and renal calcium. The amount of vitamin D3 in the formulation is ranging from 0.00005 % to 0.100 % w/v by weight of total formulation.
The present invention provides effervescent tablet compositions for a combination of micronized Eggshell and stabilized vitamin D3. The said compositions comprise combination of micronized Eggshell and stabilized vitamin D3. The other excipients used to arrive at the final compositions include surfactants life Polysorbate 80, sodium lauryl sulfate, binders like hypromellose, povidone, buffering agents like citric acid anhydrous, moisture barrier agent like simethicone, lubricants like colloidal silicon dioxide (Aerosil 200), purified talc and flavouring and colouring agents.
Suitably a formulation according to the present invention provides an effervescent dosage form, comprising of micronized Eggshell and stabilized vitamin D3 along with other pharmaceutically acceptable excipients.
In one embodiment, the effervescent composition of the present invention is capable of being inserted into a liquid. The effervescent composition includes at least one compound and is capable of effervescence in the presence of moisture.
In yet another embodiment, a method for making an effervescent composition comprises the steps of providing a composition comprising at least one compound, the composition capable of effervescence in the presence of moisture, wherein the. composition substantially avoids effervescence by the composition until the composition contacts a liquid.

The term "effervescent," as defined herein, means any product capable of forming bubbles in liquid environments and may also be considered any product capable of liberating carbon dioxide in or out of liquid environments. Likewise, "effervescence" means forming bubbles in liquid environments or liberating carbon dioxide in or out of liquid environments.
Examples of acids suitable for use in these illustrative embodiments include, but are not limited to, tartaric acid, citric acid, fumaric acid, adipic acid, malic acid, oxalic acid, or sulfamic acid, either alone or in combination. Typically, the effervescent of these embodiments is prepared from citric acid or a combination of citric acid and tartaric acid. Use of citric acid alone may cause difficulties during the manufacturing process. For example, use of citric acid alone may result in a sticky mixture that is difficult to granulate.
Examples of salts suitable for use in illustrative embodiments include, but are not limited to, the alkali metal salts. Sodium carbonate, calcium carbonate, magnesium carbonate, ammonium carbonate, potassium carbonate, sodium bicarbonate, and calcium bicarbonate may all be employed.
The present invention further comprises a process of preparing a pharmaceutical product, or pharmaceutical compositions, or a medicament substantially as herein before
described.
Micronized Eggshell is granulated along with Polysorbate 80 and hypromellose. Second step of granulation includes citric acid, tartaric acid, simethicone and isopropyl alcohol. The third step of granulation includes sodium bicarbonate, sodium carbonate, povidone and isopropyl alcohol. The final step includes lubrication with stabilized vitamin D3; aspartame, sodium lauryl sulphate, colloidal silicon dioxide (Aerosil 200), purified talc, sodium benzoate and addition of orange flour DC 116 PH and sunset yellow lake and final compression of the tablet.

Surfactants are essential components and help to reduce the surface tension of water by adsorbing at the liquid-gas interface. They are compounds that have hydrophobic and hydrophilic portions that act to reduce the surface tension of the aqueous solutions they are dissolved in. Useful surfactants can include anionic, nonionic, amphoteric, and cationic surfactants, and blends thereof. Preferably, the surfactants used are sodium lauryl sulphate/Polysorbate 80.
Binders hold the ingredients together so that they can form a tablet. Povidone also known as polyvinyl pyrrolidone (PVP) is one of the most commonly used pharmaceutical binders.
Lubricants are added to pharmaceutical compositions for ease in processing, to prevent adhesion to the equipment used during processing. Lubricants used in the compositions include lubricants commonly used in solid pharmaceutical compositions. Lubricants used in the compositions include, but are not limited to, calcium stearate, colloidal silicon dioxide (Aerosil 200), glyceryl behenate, magnesium stearate, mineral oil, polyethylene glycol, sodium stearyl rumarate, stearic acid, talc, vegetable oil, sodium lauryl sulfate, or zinc stearate. Preferably, the lubricants are purified talc/ colloidal silicon dioxide (Aerosil 200).
Sweetening agents are used to sweeten pharmaceutical compositions. Sweetening agents used in the compositions include sweetening agents commonly used in solid pharmaceutical compositions. Sweetening agents include, but are not limited to, aspartame, dextrates, dextrose, fructose, mannitol, saccharin, sorbitol, sucralose, sucrose, sugar, or syrup. Preferably, the sweetening agent is aspartame.
Flavoring agents make pharmaceutical compositions more palatable to the patient. Flavoring agents commonly used in pharmaceutical compositions include maltol, vanillin, ethyl vanillin, menthol, citric acid, fumaric acid, ethyl maltol, tartaric acid,

peppermint, artificial or natural fruit flavors. Flavoring agents used in the compositions include, but are not limited to, orange flavour DC 116 PH.
Coloring agents improve the appearance of pharmaceutical compositions and/or facilitate patient identification of the compositions. Coloring agents used in the compositions include coloring agents commonly used in solid pharmaceutical compositions. Coloring agents used in the composition include, but are not limited to, caramel, ferric oxides (red, yellow, or black), or natural or synthetic organic colors and lakes.
In one preferred embodiment, the pharmaceutical dosage present in effervescent tablet form comprises combination of Eggshell powder and stabilized vitamin D3, and about 0.3-0.6% by weight Polysorbate 80, 0.10-0.3 % by weight hypromellose, 1.0-12 % by weight citric acid, 20-30 % by weight tartaric acid, 0.3-0.6 % by weight simethicone, 30-40 % sodium bicarbonate, 4-8 % by weight sodium carbonate, 1-2 % by weight povidone, 2-4 % by weight aspartame, 0.5-1.5% by weight sodium lauryl sulphate and 0.1-0.6 % by weight colloidal silicon dioxide (Aerosil 200) , 0.1-0.3 % by weight purified talc, 0.3-0.7 % by weight sodium benzoate, 1-3 % by weight sunset yellow, 0.1-0.3% by weight orange flavour.
. The present invention provides process for the preparation of an effervescent tablet consisting of compositions of micronized Eggshell and stabilized vitamin D3.
The present invention will now be illustrated with reference to the following examples, which does not limit the scope of the invention in any way. Further different strengths of the formulation may be achieved by proportionately using a dose weight scale-up or scale-down formula. The concentration of the excipients may also be varied or modified to achieve the desired dissolution profile by a skilled artisan.
Example 1:
Effervescent tablets of micronized Eggshell and stabilized vitamin D3 were prepared using the following excipients in the stated quantities:

S.No.
Ingredients Quantity per Tablet in mg %w/w
Granulation I
1. Micronized Eggshell 480 12.37
2. Polysorbate 80 20 0.51
3. Hypromellose (HPMC-5 CP) 10 0.25
4. Purified water q.s
Granulation II
5. Stabilized vitamin D3 0.03 0.001
6. Citric acid (anhy.) 480 . 11.59
7. Tartaric acid 900 23.19
8. Simethicone 20 0.51
9. Isopropyl Alcohol q.s —
Granulation III
10. Sodium bicarbonate 1400 36.08
11. Sodium carbonate 175 4.51
12. Povidone 60 1.28
13. Isopropyl Alcohol q.s —
Lubrication
14. Aspartame 90 2.31
15. Sodium Lauryl Sulphate 50 1.03
16. Colloidal silicon dioxide (Aerosil 200) 30 0.51
17. Purified Talc 20 0.25
18. Sodium benzoate 35 0.64
19. Orange flavour DC116 PH 100 0.25
20. Sunset yellow lake 10 2.57
Total weight 3880 mg

Procedure:
Micronized Eggshell is granulated along with Polysorbate 80 and hypromellose. Second step of granulation includes citric acid, tartaric acid, simethicone and isopropyl alcohol. The third step of granulation includes sodium bicarbonate, sodium carbonate, povidone and isopropyl alcohol. The final step includes lubrication with vitamin D3, aspartame, sodium lauryl sulphate, aerosil, purified talc, sodium benzoate and addition of orange flour DC 116 PH and sunset yellow lake and final compression of the tablet. .
Example 2:
Effervescent tablets of micronized Eggshell and stabilized vitamin D3 were prepared using the following excipients in the stated quantities:

S.No. Ingredients Quantity per Tablet in mg %w/w
Granulation I
1. Eggshell Powder 240 8.33
2. Polysorbate 80 15 0.52
3. Hypromellose (HPMC-5 CP) 5 0.17
4. Purified water q.s —
Granulation II
■5. Vitamin D3 0.02 0.002
6. Citric acid (anhy.) 350 12.15
7. Tartaric acid 800 27.77
8. Simethicone 15 0.52
9. Isopropyl Alcohol q.s —
Granulation III
10. Sodium bicarbonate 1000 34.72
11. Sodium carbonate 155 5.38
12. Povidone 45 1.56
13. Isopropyl Alcohol q.s . —
Lubrication

14. Aspartame 85 2.60
15. Sodium Lauryl Sulphate 38 0.97
16. Colloidal silicon dioxide (Aerosil 200) 9 0.31
17. Purified Talc 7 0.24
18. Sodium benzoate 24 0.48
19. Orange flavour DC116 PH 88 0.13
20. Sunset yellow lake 4 2.70
Total weight 2880 mg
Procedure: Same as mentioned in Example 1.
Example 3:
Effervescent tablets of micronized Eggshell and stabilized vitamin D3 were prepared using the following excipients in the stated quantities:

S.No. Ingredients Quantity per Tablet in mg %\v/w
Granulation I
1. micronized Eggshell 120 6.38
2. Polysorbate 80 9 0.47
3. Hypromellose (HPMC-5 CP) 3 0.15
4. Purified water q.s —
Granulation II
5. Vitamin D3
6. Citric acid (anhy.) 190 10.10
7. Tartaric acid 550 29.25
8. Simethicone 9 0.47
9. Isopropyl Alcohol q.s —
Granulation III
10. Sodium bicarbonate 700 37.23

11. Sodium carbonate 124 6.59
12. Povidone 24 1.27
13. Isopropyl Alcohol q.s —
Lubrication
14. Aspartame 42 2.23
15. Sodium Lauryl Sulphate 14 0.74
16. Colloidal silicon dioxide (Aerosil 200) 5 0.26
17. Purified Talc 4 0.21
18. Sodium benzoate 10 0.53
19. Orange flavour DC 116 PH 54 0.10
20. Sunset yellow lake 2 2.87
Total weight 1880 mg
Procedure: Same as mentioned in Example 1.

We claim:
1. An oral pharmaceutical effervescent tablet composition comprising: a therapeutically effective amount of micronized Eggshell and stabilized vitamin D3.
2. The composition according to claim 1, further comprises of effervescent agents, buffering agents, surfactants, along with pharmaceutically acceptable excipients.
3. The composition of claim 2, wherein the pharmaceutically acceptable excipients include moisture barrier agents, binders, flavours, sweeteners, colours and lubricants.
4. The composition according to claim 2, theeffervescent agents being sodium carbonate and/or sodium bicarbonate, wherein sodium carbonate is present in an amount of about 4-8% w/w of the total weight of the composition, sodium bicarbonate is present in an amount of about 30-40% w/w of the total weight of the composition.
5. The composition according to claim 2, the buffering agents being citric acid and/or tartaric acid, wherein citric acid is present in an amount of about 10-12 % w/w of the total weight of the composition, tartaric acid is present in an amount of about 20-30% w/w of the total weight of the composition.
6. The composition according to claim 2, the surfactants being Polysorbate 80 and/or sodium lauryl sulphate and/or sodium benzoate, wherein Polysorbate 80 is present in an amount of about 0.3-0.6% w/w of the total weight of the composition, sodium lauryl sulphate is present in an amount of about 0.5-1.5 % w/w of the total weight of the composition and sodium benzoate is present in an amount of about 0.3-0.7 % w/w of the total weight of the composition.
7. The composition according to claim 3, the moisture barrier agent preferably being simethicone in an amount of about 0.3-0.6 % w/w of the total weight of the composition, and the binders preferably being hypromellose, povidone and/or isopropyl alcohol present in an amount of about 0.1-2 % w/w of the total weight of the composition.

8. The composition of claim 3. the lubricants preferably being colloidal silicone dioxide and/or purified talc present in an amount of about 0.1-1.5% w/w of the total weight of the composition, the flavouring agent is present in an amount of about 0.1-0.3% w/w of the total weight of the composition, colouring agent is present in an amount of about 1 -3 % w/w of the total weight of the composition and sweetening agent is present on an amount of about 2-4% w/w of the total weight of the composition.
9. A process for making effervescent tablet of micronized Eggshell and stabilized vitamin D3 comprising the steps of:

a) granulating Eggshell powder with surfactants
b) granulating vitamin D3- buffering agents with moisture barrier agents to avoid pre-moisture contact of the actives
c) granulating carbonates avoids pre-moistening
. d) Lubricating with lubricants or colours or flavours and final compression of the tablet.
10. The pharmaceutical composition of claim 1, wherein the said composition is used as a
natural source of calcium supplement for treatment of calcium deficiency
disorders/disorders.

Documents

Application Documents

# Name Date
1 3034-MUM-2013-AbandonedLetter.pdf 2020-02-19
1 3034-MUM-2013-AFR-09-10-2013.pdf 2013-10-09
2 3034-MUM-2013-Other Patent Document-240816.pdf 2018-08-11
2 3034-MUM-2013-FER.pdf 2019-06-27
3 3034-MUM-2013-FORM 5.pdf 2018-08-11
3 3034-MUM-2013-ABSTRACT.pdf 2018-08-11
4 3034-MUM-2013-CLAIMS.pdf 2018-08-11
4 3034-MUM-2013-FORM 3.pdf 2018-08-11
5 3034-MUM-2013-FORM 2.pdf 2018-08-11
5 3034-MUM-2013-CORRESPONDENCE.pdf 2018-08-11
6 3034-MUM-2013-FORM 2(TITLE PAGE).pdf 2018-08-11
6 3034-MUM-2013-DESCRIPTION(COMPLETE).pdf 2018-08-11
7 3034-MUM-2013-Form 18-240816.pdf 2018-08-11
7 3034-MUM-2013-FORM 1.pdf 2018-08-11
8 3034-MUM-2013-Form 18-240816.pdf 2018-08-11
8 3034-MUM-2013-FORM 1.pdf 2018-08-11
9 3034-MUM-2013-FORM 2(TITLE PAGE).pdf 2018-08-11
9 3034-MUM-2013-DESCRIPTION(COMPLETE).pdf 2018-08-11
10 3034-MUM-2013-CORRESPONDENCE.pdf 2018-08-11
10 3034-MUM-2013-FORM 2.pdf 2018-08-11
11 3034-MUM-2013-CLAIMS.pdf 2018-08-11
11 3034-MUM-2013-FORM 3.pdf 2018-08-11
12 3034-MUM-2013-FORM 5.pdf 2018-08-11
12 3034-MUM-2013-ABSTRACT.pdf 2018-08-11
13 3034-MUM-2013-Other Patent Document-240816.pdf 2018-08-11
13 3034-MUM-2013-FER.pdf 2019-06-27
14 3034-MUM-2013-AFR-09-10-2013.pdf 2013-10-09
14 3034-MUM-2013-AbandonedLetter.pdf 2020-02-19

Search Strategy

1 TPO3034MUM2013_12-04-2019.pdf