FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
PATENTS RULES, 2003
(COMPLETE SPECIFICATION)
TITLE OF INVENTION - "COMPACT DOSAGE FORM FOR THE TREATMENT OF MENOPAUSE AND OTHER WOMAN RELATED DISEASES."
NAME OF APPLICANT - ZOTA HEALTH CARE LTD
ADDRESS OF APPLICANT- ZOTA HEALTH CARE LTD
ZOTA HOUSE
2/896, HIRA MODI STREET, SAGRAMPURA, SURAT - 395002 (GUJARAT). INDIA.
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION
The present invention pertains to the pharmaceutical dosage form which is mainly focus on women health related which may be come during pregnancy, post pregnancy, menopause, post menopause or several joint diseases.
BACKGROUND OF THE INVENTION
Menopause describes the phase in a woman's life when her body stops producing eggs, the levels of estrogen and progesterone drop and menstrual flow becomes less frequent, sporadic and then stops completely. Doctors consider a woman in post-menopause 12 months after her last menstrual cycle. Although a natural part of life, menopause triggers a variety of symptoms, most caused by the drop in hormones.
When she goes through menopause, hormones fluctuations changes her body composition. The loss of muscle and the accumulation of fat could cause discomfort and stiffness in her muscles and joints. Many physicians may recommend medications and (nutritional supplements) or lifestyle changes to treat muscle stiffness that occurs during menopause.
During menopause, women lose cartilage between the joints. Fluid between the joints decreases and after that joints are less flexible. A side effect of the changes includes stiffness in the joints and muscles. Muscle fibers shrink as women age and lost tissue is replaced at a much slower rate. The changes in the muscle lessen the ability to contract muscles. The stiffness may result from the rigidness in the muscles. The decrease in estrogen can be an attributing factor to muscle stiffness experienced by menopausal and post-menopausal women. Women that have gone through menopause have less lean muscle mass than women who have yet to go through menopause. Although aging causes a loss of muscle mass, changes in the release of hormones are believed to accelerate how quickly muscle is lost and decreases in muscular function.
Following menopause, bones lose minerals including magnesium and bone density decreases because calcium isn't as easily incorporated into bones with the decreased level of estrogen.
This loss of bone density makes bones fragile and more likely to break especially the bones of the wrist, hip and spine.

Some existing inventions are following-
In US 2011/0020443 Al (patent application)/WO 2011/003045 Al (patent application) wherein The present invention provides compositions that contain magnesium and threonate, or a threonate precursor molecule, formulated for extended or modified release to provide physiological concentrations over a desired time period. The extended release or modified release form is particularly useful in providing Mg to a subject while avoiding adverse side effects such as diarrhea.
In Patent Number: 1556025 wherein this invention provides the first form of directed therapy for reducing age-related arterial stiffening (as distinct from stiffening due to atherosclerosis). Arterial elastic properties (compliance and dispensability) deteriorate with age. However, the severity of this downward trend was found to be significantly reduced in a group of menopausal women who regularly consumed a supplement of vitamin K (plus Vitamin D) over the course of 3 years. These women were selected for the study on the basis of criteria which included a lack of evidence of atherosclerotic disease and low risk factors for the disease.
However there is no formulation or composition for the treatment of osteoporosis before, during the menopause, postmenopause, Osteoporosis thereof.
SUMMARY OF THE INVENTION
In one aspect of the invention is to provide a compact dosage form for containing desirable ingredients which able to overcome various symptoms/ diseases.
In one aspect of the invention is to provide a compact dosage form with appropriate quantity.
Another aspect of the present invention is that it's mainly capable for fulfill the entire requirement which are essential to a woman before pregnancy or post pregnancy. As well as menopause, post menopause.
Yet another aspect of the present invention is that it overcomes other symptoms / diseases which are normally occur at that time.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and claims.

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.
According to invention some active ingredients are capable to full fill requirement for the treatment of various disease, especially focus on bone and woman related diseases such as menopause, pregnancy, post menopause, Osteoporosis thereof.
The invention is therefore advantageous in that it allows this formulation would be available in various dosage forms, according to requirement for example Capsules, Tablets, Syrup, Loranzes Local cream, ointment, gel, Spray, But in oral and local should cover all applications.
This combination is particularly useful in the treatment of Osteoporosis disease such as Senile osteoporosis, Idiopathic juvenile osteoporosis, Postmenopausal osteoporosis, in which the density of bones has become reduced, bones becomes weak and fragile and can occur fracture, some time bones of the skeleton has become porous and fragile due to excessive loss of bone tissue. This fragility of bone may lead to fracture. Bones which are more prone to fracture are the hip, the wrist, and the spine.
In Postmenopausal osteoporosis is caused by a lack of estrogen, the main female hormone, which helps in incorporation of calcium in the women. Which is absent during the menopause. Thereby, bone building is stopped and resorption is continued.
During to Pregnancy imposes a heavy demand on the body especially for calcium. An infant at birth has more than 20 to 30 gms of calcium, which is accumulated when the bones of the fetus are ossifying. About 1.2 gms of calcium per day are requiring during pregnancy.
Pregnancy and lactation impose stress on the calcium homeostasis of the mother and as the bone is the largest store of calcium, some loss is expected to be incurred in orders to meet the increased demand. It has been observed that a complex hormonal regulatory mechanism counteracts bone by retaining excess calcium in the circulation, but osteoporosis without any reason appears during pregnancy and postpartum.

In a preferred embodiment, wherein Calcitriol used as a active ingredient which is a type of vitamin D analogue, sometimes known as a derivative of vitamin D ( active form of Vitamin D ).Vitamin D helps control parathyroid hormone and the levels of certain minerals (example calcium, phosphorus) that are needed for building and keeping strong bones. Calcitriol is mainly used to treat bone disease and weakening of the bones in women after the menopause (post-menopausal osteoporosis). Vitamin D is essential for the proper absorption of calcium. Vitamin D deficiency in postmenopausal women adds to osteoporosis risk.
The calcitriol is used in the range between 0.15 meg to 0.50 meg more preferably in 0.25 meg.
In a further embodiment of the invention wherein Calcium has an important role in hypertensive disorders in pregnancy. There is strong evidence that calcium supplementation results in an important reduction in PIH and Pre -eclampsia. In a double blind clinical trial, the CaCo3 supplemented group showed no increase in BP whereas the placebo group showed normal patterns of BP increases during late pregnancy.
The Calcium is used in the range between 475 mg to 525 mg more preferably in 500 mg.
This invention is highlighting efficient high potential calcium with vitamin D therapy with inbuilt advantage of magnesium and zinc for Pregnancy Induced Hypertension (P.I.H) and pre-eclampsia.
In the embodiment of the invention wherein Magnesium intake is strongly associated with lower blood pressure. It reduces premature labor. It showed significant reduction in maternal and fetal morbidity, both before and after delivery. The Magnesium is used in the range between 25 mg to 75 mg more preferably in 50 mg.
Pregnancy significantly reduces the incidence of spontaneous abortion and premature birth while favorably changing the intra-uterine fetal development. The lack of magnesium causes abnormalities in skeletal structure and mineralization, resulting in common bone diseases including osteoporosis. There is an increased need for magnesium in osteoporosis and rebuild bone mass.
The combination of Magnesium and Calcium prevents Cramps during pregnancy because Magnesium deficiency during pregnancy is associated with hypertension, premature delivery, intra-uterine growth retardation and muscle cramping and the first sign of calcium deficiency

is a nervous problem, tetany, characterized by muscle cramps and numbness and tingling in the arms and legs. Other advantage of this combination wherein magnesium is essential to regulate calcium metabolism. Magnesium deficiency leads to hypocalcaemia which persists despite increased calcium intake until the deficit of magnesium is corrected. Low intakes of magnesium reduces calcium metabolism and increase urinary calcium excretion with increased risk of kidney stone formation
In the embodiment of the invention wherein Zinc is an essential for safe pregnancy. Women with low levels of plasma Zinc clearly face an increased risk of malformed fetus and /or miscarriages. The lack of Zinc impairs the synthesis of DNA and metalloenzymes and is an associated factor in the aetiology of fetal abnormalities. Zinc intakes during pregnancy results in greater infant weight and fewer antenatal complications. Zinc is needed to produce a matrix of protein threads on which the bone forming calcium is laid.
The zinc is used in the range between 5 mg to 15 mg more preferably in 10 mg.
The combination of Zinc and Vitamin D wherein it stimulate to bone mineralization. This effect is based on stimulation of the DNA synthesis in the bone cells.
In the embodiment of the invention wherein Vitamin K is needed for the post translational modification, for blood coagulation and metabolic pathways in bone (bone metabolism) and other tissue, for blood coagulation. As per the study about Vitamin K2 (MK4, but not MK7 or Vitamin Kl) has shown to prevent bone loss and / or fractures and Post menopausal osteoporosis helps in deposition of calcium.
The Vitamin K27 is used in the range between 75 meg to 120 meg more preferably in 100 meg.
In the embodiment of the invention wherein Racemethionine contributes to the synthesis of S-adenosylmethionine, which promotes production of cartilage proteoglycans, and is therapeutically beneficial in osteoarthritis.
The Racemethionine is used in the range between 30 mg to 52 mg more preferably in 50 mg.
In the embodiment of the invention wherein Taurine is the most abundant amino acid in your muscles, heart, brain, retinas and white blood cells. Body does not use taurine as a component of proteins; instead it is used as a free amino acid. Taurine serves a variety of important

functions, including as an antioxidant and immune-boosting molecule. Some of taurine's health benefits may help alleviate certain menopause symptoms. It's also good for the anxiety of menopause.Taurine increases the muscules strength and capability.
The Taurine is used in the range between 175 mg to 220mg more preferably in 200 mg.
The main advantages of the invention are following:
Pregnancy and lactation
Prevention of osteoporosis.
Post Menopausal osteoporosis
Reduces complications of pregnancy

COMPARATIVE EXAMPLES
The pharmaceutical formulation comprising following active ingredients are described in more detail in the examples section below.
Example A
The examples demonstrate an attempt to prepare a pharmaceutical formulation for the treatment of menopause, post menopause, Osteoporosis thereof.

INGREDIENTS QUANTITY
Calcitriol 0.15 meg
Cal. Carbonate 475 mg
Vitamin K27 75 meg
Magnesium 25 mg
Zinc Sulphate 5mg
Taurine 175 mg
Racemethionine 50 mg
Other ingredients q.s.

Example B
The examples demonstrate an attempt to prepare a pharmaceutical formulation for the treatment of menopause, post menopause, Osteoporosis thereof.

INGREDIENTS Quantity ( Optimum)
Calcitriol 0.25 meg
Cal. Carbonate 500 mg
Vitamin K27 100 mcg
Magnesium 50 mg
Zinc Sulphate 10 mg
Taurine 200 mg
Racemethionine 50mg
Other ingredients q.s.

Example C
The examples demonstrate an attempt to prepare a pharmaceutical formulation for the treatment of menopause, post menopause, Osteoporosis thereof.

INGREDIENTS Quantity
Calcitriol 0.50 mcg
Cal. Carbonate 525 mg
Vitamin K27 120 mcg
Magnesium 75 mg
Zinc Sulphate 15 mg
Taurine 220 mg
Racemethionine 50 mg
Other ingredients q.s.

CLAIMS,
We claim,
1. Compact dosage form comprises of calcitriol, (calcium), Cal. Carbonate, vitamin K27, Magnesium, Zinc Sulphate, taurine, racemethionine thereof.
2. Compact dosage form of claim 1, wherein it's mainly focus on women health which may be come during pregnancy, post pregnancy, menopause, post menopause or several joint diseases , PIH (Pregnancy induced hypertension).
3. Compact dosage form of claim 1, wherein calcitriol helps control parathyroid hormone and the levels of certain minerals (example calcium, phosphorus) that are needed for building and keeping strong bones. Calcitriol is mainly used to treat bone disease and weakening of the bones in women after the menopause (post-menqpausal osteoporosis).The calcitriol is used in the range between 0.15 meg to 0.50 mcg more preferably in 0.25 mcg.
4. Compact dosage form of claim 1, wherein Calcium has an important role in hypertensive disorders in pregnancy. There is strong evidence that calcium supplementation results in an important reduction in PIH and Pre -eclampsia. (Calcium helps in increasing bone density and maintains BMD). The Calcium is used in the range between 475 mg to 525 mg more preferably in 500 mg.
5. Compact dosage form of claim 1, wherein Magnesium intake is strongly associated with lower blood pressure. It reduces premature labor. It showed significant reduction in maternal and fetal morbidity, both before and after delivery. Magnesium helps in deposition of calcium on bone matrix .The Magnesium is used in the range between 25 mg to 75 mg more preferably in 50 mg.
6. Compact dosage form of claim 4 & claim 5, wherein Magnesium and Calcium is prevent legs Cramps during pregnancy because Magnesium deficiency during pregnancy is associated with hypertension, premature delivery, intra-uterine growth

retardation and muscle cramping and the first sign of calcium deficiency is a nervous problem, tetany, characterized by muscle cramps and numbness and tingling in the arms and legs.
7. Compact dosage form of claim 1, wherein Zinc is Essential for safe pregnancy. Zinc is needed to produce a matrix of protein threads on which the bone forming calcium. The zinc is used in the range between 5 mg to 15 mg more preferably in 10 mg.
8. Compact dosage form of claim 1, wherein Racemethionine contributes to the synthesis of S-adenosylmethionine, which promotes production of cartilage proteoglycans, and is therapeutically beneficial in osteoarthritis. Racemethionine is used in the range between 30 mg to 52 mg more preferably in 50 mg.
9. Compact dosage form of claim 1, wherein. Taurine serves a variety of important functions, including as an antioxidant and immune-boosting molecule. Some of taurine's healths benefits may help alleviate certain menopause symptoms, increases muscles strength and capability. It's also good for the anxiety of menopause. The Taurine is used in the range between 175 mg to 220mg more preferably in 200 mg.
10. Compact dosage form of claim 1, wherein vitamine K27 prevent bone loss and / or fractures and Post menopausal osteoporosis. The Vitamin K27 is used in the range between 75 meg to 120 meg more preferably in 100 meg.