DESCRIPTION
FIELD OF THE INVENTION
The present invention is related to a Ayurvedic formulation comprising Khatika
Churna (Calcium Carbonate) in the syrup and in the form of chewable tablets.
The invention provides the patient compliance by providing the formulation in
various flavors as well as excluding out the gritty nature of khatika churna.
PRIOR ART TO THE INVENTION
Antacids used today are made from a variety of inorganic salts such as Galcium
carbonate, sodium bicarbonate, magnesium salts and· aluminum salts.
Magnesium hydroxide and aluminum hydroxide are the most potent magnesium
and aluminum compounds and are often used in combination. In addition,
magnesium oxide, magnesium carbonate, aluminum phosphate, magaldrate
and magnesium trisilicate are also employed.
Antacids are available in both liquid suspensions as well as solid dosage forms.
ln. general, liquid antacid suspensions are preferred to tablets or powders since
they are more rapidly and effectively solubilized and have a greater ability to
react with and neutralize gastric acid.
The use of calcium carbonate as the effective acid neutralizing agent in antacid
tablets is known. The problem with calcium carbonate as an ingredient in
antacid tablets, however, is that, unless formulated in special ways, it produces
tablets which taste gritty and chalky and which thus lack the desirable quality in
chewable antacid tablets known as good "mouthfeel"
US 6284265 discloses an antacid formulation comprises 11.0-45.0% antacid
selected from a group consisting of aluminum phosphate, dihydroxy-aluminumsodium-
carbonate, dicalcium phosphate, calcium carbonate and mixtures
thereof, 4.0-8.0 oil, 0.02-1.0% antioxidant and 46.0-84.5% carrier.
US 5914135 relates to Calcium carbonate liquid antacid compositions
containing one or more pH adjusting agents to maintain the pH above 9.0,
preferably above 9.5. The resultant antacid liquid possesses superior resistance
to microbial attack and enhanc::ed taste properties.
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us 5629013 comprises chewable antacid tablet
compositions calcium carbonate sweetened with aspartame, and preferably
also saccharin wherein said composition is in a solid unit dose form to be
ingested by chewing.
WO 1999/045937 relates to The present invention relates to a high
dosage calcium carbonate aqueous antacid pharmaceutical suspension for oral
use, and methods of preparation.
US 5455050 relates to The present invention relates to an aqueous
pharmaceutical suspension for oral use, and a method of preparation,
having antacid and antiulcer properties which contains a therapeutically
effective amount of calcium carbonate in combination with magnesium
carbonate and/or magnesium trisilicate and a carboxylic acid pH adjusting
agent.
EP 0377906 discloses An effervescent analgesic antacid composition having
reduced sodium content is produced from a mixture of an analgesic, such as
· acetylsalicylic acid, acetaminophen, ketoprofen or a mixture thereof, citric acid,
sodium bicarbonate, calcium carbonate, potassium bicarbonate, and minor
amounts of flavors and sweeteners.
US 5762962 relates to antacid pharmaceutical compositions provide optimal
buffering profiles of from 3.0 to 5.0 for immediate and long lasting relief from the
symptoms of acid indigestion, sour stomach, heartburn and gas. The
composition may comprise a dual or tripartite combination of the
actives calcium carbonate, calcium or magnesium citrate
and/or calcium phosphate which, as a result of their different activities,
neutralize the excess stomach acid both immediately and continuously over
time. The formulations also provide the individual with alternative dosage forms
which may provide greater levels of calcium, less sodium and less production of
gastrointestinal gas.
WO 1994/027577 discloses liquid antacid compositions for neutralizing stomach
acid in humans and other animals comprising: (a) calcium carbonate; (b) short
chain alkyl esters of p-hydroxybenzoic acid; (c) benzyl alcohol; (d) optionally,
but preferably, bis-biguanide compound or a pharmaceutically-acceptable salt
thereof; and (e) other excipients. These compositions are further preferably
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formulated to contain an elevated soluble solids content at a level which will
increase the shelf stability of the composition.
Further the prior art also discloses about the problems of taking oral
formulations of Calcium carbonate like grittiness and chalky taste.
None of the above cited prior art has improved the grittiness and taste
simultaneously, thereby does not making the formulation fully in compliance to
the patients. Thus there exists a need for a formulation of calcium carbonate
which provides simultaneous elimination of grittiness and chalky taste.
OBJECT OF THE INVENTION
The object of the present invention is to provide a ayurvedic formulation
providing relief from acidity.
Another object of the present invention is to provide a formulation which does
contain gritty nature.
Yet another object of the present invention is to provide a formulation that does
not have chalky taste.
Another object of the present invention is to provide a formulation that gives the
patient a quick relief from acidity with side effects.
Another object of the present invention is to make the formulation available in
various flavors providing patient compliance.
DETAILED DESCRITION OF THE INVENTION
Gastric antacids are agents that neutralize or remove acid from the gastric
contents. Antacids are widely used in the treatment of various gastrointestinal
disorders such as peptic ulcers and gastritis. Antacids are also used for the
relief of acid indigestion, heartburn, dyspepsia, sour stomach, reflux esophagitis
and the like. The clinical use of antacids is based on their ability to neutralize
stomach acid and increase the pH of gastric secretions. Although antacids do
not neutralize all gastric acid, increasing gastric pH from 1.3 to 2.3 neutralizes
90% and increasing pH to 3.3 neutralizes 99% of gastric acid. For optimal
healing of peptic ulcers, most clinicians believe that gastric pH should be
maintained at about 3-3.5. Accordingly, it is desirable that an antacid feature a
high acid neutralization capacity and a rapid rate of gastric acid neutralization.
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Chewed calcium carbonate (CaC03) rapidly neutralizes esophageal acid and
may prevent reflux, suggesting another mechanism of action independent of
acid neutralization. Calcium is essential for muscle tone. The Ca2+ released
after chewing of CaC03 antacids may be partially responsible for the reduction
of heartburn by significantly improving initiation of peristalsis and acid
clearance.
The present invention discloses a oral ayurvedic formulation comprising khatika
churna as an active ingredient along with other acceptable ingredients.
The formulation can be made either in tablets or in the form of suspension.
The formulation may also be in the form of powder which can be administered
with or without water.
The main objective of the present invention is to prepare a formulation, either in
tablet or in suspension, which does not have grittiness on administration and
does not have any chalky taste.
Suspension is prepared in different flavors such as Vanilla, Guava, Orange,
Pineapple, Mango, Lemon, and the combined flavor of Black current and Zeera.
Chewable Tablet is formulated in the flavors like Mix fruit, Tutti Frutti, ·Mint and
Zeera.
The ingredients used in the formulation of suspension comprises of Khatika
churna, Xanthum gum, Sorbitol solution, Glycerin, Propylene glycol, Methyl
Paraban, Propyl paraban, citric acid and flavoring and coloring agents.
The ingredients used in chewable tablet comprises of Khatika Churna,
Dextrose monohydrate, Polyvinyl pyrrolidone, Glucose granules, Sweetening
agent, and flavoring agent.
The tablet and the suspension is formulated through the normal manufacturing
process.

CLAIMS
We Claim:
1) An flavoured Ayurvedic formulation comprising Khatika Churna along
with excipients.
2) The Ayurvedic formulation as claimed in claim 1 may be tablet or
suspension or powder.
3) The tablet as claimed in claim 2 may be preferably chewing tablets.
4) The flavours as claimed in claim 1 may be selected from Vanilla, Guava,
Orange, Pineapple, Mango, Lemon, and the combined flavor of Black
current and Zeera or the combination of above.
5) The excipients as claimed in claim 1 may be selected from Xanthum
gum, Sorbitol solution, Glycerin, Propylene glycol, Methyl Paraban,
Propyl paraban, citric acid, Dextrose monohydrate, Polyvinylpyrrolidone,
Glucose granules, Sweetening agent and flavouring agent.