WO2010133793A1 - Drug containing calcium and vitamin d - Google Patents
Drug containing calcium and vitamin d Download PDFInfo
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- WO2010133793A1 WO2010133793A1 PCT/FR2010/050947 FR2010050947W WO2010133793A1 WO 2010133793 A1 WO2010133793 A1 WO 2010133793A1 FR 2010050947 W FR2010050947 W FR 2010050947W WO 2010133793 A1 WO2010133793 A1 WO 2010133793A1
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- vitamin
- pharmaceutical composition
- calcium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/10—Carbonates; Bicarbonates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
Definitions
- the present invention relates to a novel calcium-based drug, especially calcium carbonate, and vitamin D, as well as its use in the treatment and prevention of osteoporosis.
- Osteoporosis is a disease characterized by excessive fragility of the skeleton, due to a decrease in bone mass and alteration of bone microarchitecture. It is a common disease in women after menopause because bone mass decreases with age and with deficiency of female hormones (estrogen). It affects men less often than women and exceptionally children.
- Most tablets are dosed between 400 IU and 800 IU vitamin D for 500 mg or 1000 mg of calcium.
- the dosage is 2 tablets per day for 500 mg and 1 tablet per day for 1000 mg of calcium.
- the object of the present invention is to provide a new combination vitamin D and calcium supplementation treatment while minimizing the problems resulting in the non-observance of the treatments.
- the present invention relates to a medicament for its use for the prevention and treatment of osteoporosis, characterized in that it comprises two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition
- the drug of the present invention therefore comprises two active ingredients physically separated into two different pharmaceutical forms. Thus these two pharmaceutical forms are administered one after the other so that the effects of the two active ingredients vitamin D and calcium overlap.
- the main advantage of this drug is related to the administration of a single product, for example a single pharmaceutical specialty, allowing a real and effective intake of both vitamin D and calcium and avoiding the disadvantages associated with non-observance of the treatment by the patient.
- the drug of the invention ensures the amount of vitamin D ingested by the patient.
- Calcium is in particular in salt form and is chosen from carbonate, ascorbate, gluconate and chloride salts.
- the calcium is in calcium carbonate form.
- the pharmaceutical composition (B) is preferably a chewable tablet based on calcium carbonate comprising cocoa powder.
- the tablet of the invention is preferably a coated tablet comprising cocoa powder as a taste-masking agent and a compressing agent.
- a particularly preferred tablet is that described in international application WO95 / 24890.
- the medicament according to the present invention is characterized in that said abovementioned tablet comprises cocoa powder at a content ranging from 14% to 30% by weight relative to the total weight of the tablet.
- the aforementioned chewable tablet may also comprise a sweetener, preferably aspartame.
- the tablets of the invention are dandruff, by associating a sweetener in their formulation, which causes salivation at the time of setting and thus allows better absorption and minimizes the disadvantages of calcium.
- This film coating also allows a better appearance of the tablets often presented in tube and avoids the formation of calcium dust in the packaging.
- a particularly preferred tablet according to the invention has the following composition:
- the pharmaceutical composition (A) is preferably in the form of a vitamin D oral ampoule, especially vitamin D3 (cholecalciferol).
- the above-mentioned pharmaceutical composition (A) comprises from 60,000 IU to 200,000 IU of vitamin D, and preferably vitamin D3.
- the pharmaceutical composition (A) may be a liquid composition presented in ampoules, flasks, soft capsules, or any other container for packaging or delivering an oral liquid pharmaceutical preparation whose main active ingredient is vitamin D, for example cholecalciferol (vitamin D3).
- vitamin D for example cholecalciferol (vitamin D3).
- the present invention also relates to a kit comprising:
- the tablets of the kit according to the present invention are chewable tablets based on calcium carbonate comprising cocoa powder as defined above.
- the tablets comprise cocoa powder containing from 14% to 30% by weight relative to the total weight of the tablets.
- said tablets each comprise at least 70% by weight of calcium carbonate.
- the tablet of the invention comprises 1250 mg of CaCO 3 (for a total mass of 1760 mg of tablet).
- the oral vitamin D container especially a vitamin D oral ampoule, comprises from 60,000 IU to 200,000 IU of vitamin D.
- the present invention also relates to the kit as defined above, for its use for the treatment and prevention of osteoporosis.
- the kit of the invention allows to combine the benefits of a joint supplementation of vitamin D, especially D3, and calcium while minimizing the problems resulting in non-compliance treatments.
- the kit of the invention consists of 180 tablets, including tablets of Calprimum ® , and a vitamin D oral ampoule, preferably D3, dosed between 60,000 IU and 200,000 IU.
- a vitamin D oral ampoule preferably D3
- an 80,000 IU ampoule represents a supplementation equivalent to 880 IU / day, which is considered according to current scientific data as the dose required for optimal supplementation.
- the ampoule of Vitamin D is to be taken in a single dose at the beginning of the trimester and the calcium tablets are absorbed at the rate of 2 tablets per day during the 3 months of the trimester.
- vitamin D supplementation in a single quarterly dose prevents serum vitamin D levels from being at risk of falling below the parathyroid hormone retrocontrol limit.
- vitamin D and parathyroid hormone are closely linked in the regulation of blood calcium levels.
- Vitamin D deficiency causes a decrease in intestinal calcium absorption and causes an increase in parathyroid hormone secretion that will promote the release of bone calcium to maintain blood calcium levels.
- a vitamin D deficiency causes an increase in parathyroid hormone which promotes bone fragility.
- the maintenance of blood calcium is very important physiologically because calcium is involved in many mechanisms essential to the maintenance of good health, including bone mineralization, coagulation, muscle contraction, nerve transmission or enzymatic activities. .
- This product is therefore the guarantee that throughout the duration of the treatment the calcium brought by the supplementation is absorbed in an optimal way and above all, even in case of non-observance of the calcium treatment, the parathyroid hormone will not be stimulated in an anarchic way, which disrupts feedback mechanisms, eventually leading to bone fragility.
- the use of existing products on the market creates a risk of under-dosing of vitamin D in the event of proven poor compliance with the treatment.
- the medicament of the present invention also makes it possible to minimize the disadvantages encountered by all the treatments available on the market:
- this product is a premium product with the perfect pharmaceutical and "cosmetic" quality to offer a product whose image is less “antiquated” than the products currently on the market; - and this product is presented in the form of an innovative treatment pack allowing to differentiate itself from all the actors of the therapeutic class. To date, there is no "pack" of the two products, calcium and vitamin D, which is a real therapeutic innovation.
- the medicament of the invention may therefore be presented in the form of a kit or a Combi Pack and thus provides an ease of prescription in a therapeutic field where the aging of the population and its consequences (such as osteoporosis for example) become a real problem. public health.
- the medicament of the invention in the form of a "Combi Pack” constitutes a preventive treatment.
- the patient is not “sick” and the treatment will have to be taken throughout life.
- the present invention also relates to a method of preventing osteoporosis by administering the medicament according to the present invention.
- the prevention method according to the present invention consists in: administering to a patient a dose of vitamin D, preferably vitamin D
- the preventive treatment of the invention therefore has a quarterly periodicity.
- the present invention therefore also relates to a medicament comprising two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition (A) being based on vitamin D and the pharmaceutical composition (B) being a chewable tablet based on calcium comprising cocoa powder, for a separate administration in time, the pharmaceutical composition (A) being administered before the pharmaceutical composition (B), for its use for the prevention and treatment of osteoporosis, by oral administration on first day of each trimester of a dose of 60,000 IU to 200,000 IU of vitamin D and then by oral administration of 2 tablets per day as defined above comprising cocoa powder every day during the following days of the trimester .
- the "Combi-Pack" may be presented as follows: a suitable packaging for accommodating in a same box or container, a drinkable ampoule, a bottle, a soft capsule with a capacity of 2 to 10 ml ( more specifically 2 ml) and 1 to 9 tubes, vials, blisters or any other container to accommodate the number of tablets needed for treatment, for example 90 or 180 tablets of carbonate, ascorbate, gluconate, calcium chloride, or any other calcium salt, for example calcium carbonate, and for administering an amount of calcium of 250 mg to 2 g of calcium, for example 500 mg or 1 g.
- the present invention also relates to a medicament comprising two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition (A) being based on vitamin D and the pharmaceutical composition (B) being a chewable tablet based on calcium carbonate comprising cocoa powder, for a separate administration in time, the pharmaceutical composition (A) being administered before the pharmaceutical composition (B), for its use for the prevention and treatment of osteoporosis, by oral administration the first each quarter a dose of 60,000 IU to 200,000 IU of vitamin D, followed by oral administration of 500 mg to 1,500 mg of calcium daily for the following days of the trimester.
- This administration regime consists of administering to a patient a dose of vitamin D, preferably vitamin D3, at a given instant (OJ), in particular in the form of a drinkable ampoule at a quantity of from 60,000 IU to 200,000 IU. .
- said patient is administered calcium tablets as defined above comprising cocoa powder, at a rate of 500 mg to 1500 mg of calcium per day starting from OJ during the following days of the trimester.
- the present invention also relates to a method for preventing and / or treating osteoporosis, comprising:
- each trimester a dose of vitamin D, preferably vitamin D3, in particular in the form of a drinkable ampoule in an amount of from 60,000 IU to 200,000 IU, then to be administered to said patient during the following days of the trimester calcium tablets, preferably the tablets as defined above comprising cocoa powder, at a rate of 500 mg to 1500 mg of calcium per day.
- vitamin D preferably vitamin D3
- a drinkable ampoule in an amount of from 60,000 IU to 200,000 IU
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Abstract
Description
Médicament à base de calcium et de vitamine D Drug based on calcium and vitamin D
La présente invention concerne un nouveau médicament à base de calcium, notamment carbonate de calcium, et de vitamine D, ainsi que son utilisation dans le cadre du traitement et de la prévention de l'ostéoporose.The present invention relates to a novel calcium-based drug, especially calcium carbonate, and vitamin D, as well as its use in the treatment and prevention of osteoporosis.
L'ostéoporose est une maladie caractérisée par une fragilité excessive du squelette, due à une diminution de la masse osseuse et à l'altération de la microarchitecture osseuse. C'est une maladie fréquente chez les femmes après la ménopause car la masse osseuse diminue avec l'âge et avec la carence en hormones féminines (œstrogènes). Elle touche moins souvent les hommes que les femmes et exceptionnellement les enfants.Osteoporosis is a disease characterized by excessive fragility of the skeleton, due to a decrease in bone mass and alteration of bone microarchitecture. It is a common disease in women after menopause because bone mass decreases with age and with deficiency of female hormones (estrogen). It affects men less often than women and exceptionally children.
Il existe aujourd'hui un marché important de la supplémentation en calcium dont les indications principales sont les carences calciques notamment en période de croissance, de grossesse et d'allaitement et les traitements d'appoint des ostéoporoses.Today, there is an important market for calcium supplementation, the main indications of which are calcium deficiencies, especially during periods of growth, pregnancy and breastfeeding, and the additional treatments for osteoporosis.
De nombreux produits sont disponibles et on distingue deux grands types de produits : les produits associant de la vitamine D au calcium et les produits ne contenant que du calcium.Many products are available and there are two main types of products: products combining vitamin D with calcium and products containing only calcium.
La plupart des comprimés sont dosés entre 400 Ul et 800 Ul de vitamine D pour 500 mg ou 1 000 mg de calcium.Most tablets are dosed between 400 IU and 800 IU vitamin D for 500 mg or 1000 mg of calcium.
La posologie est de 2 comprimés par jour pour 500 mg et 1 comprimé par jour pour 1 000 mg de calcium.The dosage is 2 tablets per day for 500 mg and 1 tablet per day for 1000 mg of calcium.
Dans l'indication de l'ostéoporose le traitement est à prendre à vie. De nombreuses études cliniques réalisées récemment démontrent un réel intérêt dans la supplémentation conjointe de calcium et de vitamine D.In the indication of osteoporosis treatment is to be taken for life. Many recent clinical studies show a real interest in joint calcium and vitamin D supplementation.
Des protocoles hospitaliers sont mis en place pour détecter les déficits en vitamine D chez les femmes ménopausées.Hospital protocols are in place to detect vitamin D deficiency in postmenopausal women.
Les coûts liés aux traitements hospitaliers des fractures dues à l'ostéoporose ont considérablement augmenté ces dernières années. Les conséquences de ces fractures dans une population âgée se traduisent très souvent par une hospitalisation et une rééducation longue et coûteuse pour la collectivité et sont devenues un véritable problème de santé publique.Hospital treatment costs for fractures due to osteoporosis have increased significantly in recent years. The consequences of these fractures in an elderly population often result in long and costly hospitalization and re-education for the community and have become a real public health problem.
En raison de l'âge des patients, ces hospitalisations et immobilisations peuvent mettre en jeu le pronostic vital à l'occasion d'épisodes thrombo-emboliques en particulier. Le vieillissement de la population conduit donc aujourd'hui les autorités de santé à promouvoir la supplémentation en calcium et vitamine D.Due to the age of the patients, these hospitalizations and fixed assets may be life-threatening in particular thromboembolic episodes. The aging of the population is leading health authorities today to promote calcium and vitamin D supplementation.
Cette supplémentation calcium et vitamine D n'est plus considérée comme un traitement de confort, mais comme un véritable traitement préventif des conséquences possibles de l'ostéoporose.This calcium and vitamin D supplementation is no longer considered as a comfort treatment, but as a real preventive treatment of the possible consequences of osteoporosis.
Tous les comprimés du marché, malgré un effort considérable d'aromatisation (menthe, citron, fruits rouges), présentent un inconvénient majeur lié au goût crayeux du calcium restant en bouche après absorption. Cet inconvénient est à l'origine de la très mauvaise observance du traitement par les patients. Cette mauvaise observance, dans le cas des comprimés associant vitamine D et calcium, engendre une supplémentation trop faible en vitamine D pour être réellement efficace.All the tablets on the market, despite a considerable effort of aromatisation (mint, lemon, red fruits), have a major drawback related to the chalky taste of calcium remaining in the mouth after absorption. This disadvantage is at the origin of the very bad observance of the treatment by the patients. This poor compliance, in the case of tablets combining vitamin D and calcium, causes too little vitamin D supplementation to be really effective.
De plus il est prouvé que des faibles doses de vitamine D prises de façon sporadique peuvent s'avérer dangereuses car perturbatrices du mécanisme de rétrocontrôle de la parathormone.In addition there is evidence that low doses of vitamin D taken sporadically can be dangerous because disrupting the feedback mechanism of parathyroid hormone.
La présente invention a pour but de fournir un nouveau traitement de supplémentation conjointe de vitamine D et de calcium tout en minimisant les problèmes entraînant la non observance des traitements.The object of the present invention is to provide a new combination vitamin D and calcium supplementation treatment while minimizing the problems resulting in the non-observance of the treatments.
La présente invention concerne un médicament pour son utilisation pour la prévention et le traitement de l'ostéoporose, caractérisé en ce qu'il comprend deux compositions pharmaceutiques séparées (A) et (B), la composition pharmaceutiqueThe present invention relates to a medicament for its use for the prevention and treatment of osteoporosis, characterized in that it comprises two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition
(A) étant à base de vitamine D et la composition pharmaceutique (B) étant à base de calcium, pour une administration séparée dans le temps, la composition pharmaceutique (A) étant administrée avant la composition pharmaceutique (B). Le médicament de la présente invention comprend donc deux principes actifs séparés physiquement sous deux formes pharmaceutiques différentes. Ainsi ces deux formes pharmaceutiques sont administrées l'une après l'autre de telle sorte que les effets des deux principes actifs vitamine D et calcium se recouvrent.(A) being vitamin D-based and the pharmaceutical composition (B) being calcium-based, for a separate administration in time, the pharmaceutical composition (A) being administered before the pharmaceutical composition (B). The drug of the present invention therefore comprises two active ingredients physically separated into two different pharmaceutical forms. Thus these two pharmaceutical forms are administered one after the other so that the effects of the two active ingredients vitamin D and calcium overlap.
En effet, l'avantage principal de ce médicament est lié à l'administration d'un seul produit, par exemple une spécialité pharmaceutique unique, permettant un apport réel et efficace à la fois de vitamine D et de calcium et évitant les inconvénients liés à la non-observance du traitement par le patient.Indeed, the main advantage of this drug is related to the administration of a single product, for example a single pharmaceutical specialty, allowing a real and effective intake of both vitamin D and calcium and avoiding the disadvantages associated with non-observance of the treatment by the patient.
Le médicament de l'invention permet d'assurer la quantité de vitamine D ingérée par le patient. Le calcium est notamment sous forme de sel et est choisi parmi les sels carbonate, ascorbate, gluconate et chlorure. De préférence, le calcium est sous forme carbonate de calcium.The drug of the invention ensures the amount of vitamin D ingested by the patient. Calcium is in particular in salt form and is chosen from carbonate, ascorbate, gluconate and chloride salts. Preferably, the calcium is in calcium carbonate form.
Dans le médicament selon la présente invention, la composition pharmaceutique (B) est de préférence un comprimé à croquer à base de carbonate de calcium comprenant de la poudre de cacao.In the medicament according to the present invention, the pharmaceutical composition (B) is preferably a chewable tablet based on calcium carbonate comprising cocoa powder.
Le comprimé de l'invention est de préférence un comprimé enrobé comprenant de la poudre de cacao à titre d'agent de masquage du goût et d'agent de compression. Un comprimé particulièrement préféré est celui décrit dans la demande internationale WO95/24890.The tablet of the invention is preferably a coated tablet comprising cocoa powder as a taste-masking agent and a compressing agent. A particularly preferred tablet is that described in international application WO95 / 24890.
Selon un mode de réalisation avantageux, le médicament selon la présente invention est caractérisé en ce que ledit comprimé susmentionné comprend de la poudre de cacao à une teneur comprise de 14% à 30% en poids par rapport au poids total du comprimé.According to an advantageous embodiment, the medicament according to the present invention is characterized in that said abovementioned tablet comprises cocoa powder at a content ranging from 14% to 30% by weight relative to the total weight of the tablet.
Le comprimé à croquer susmentionné peut également comprendre un édulcorant, de préférence de l'aspartam.The aforementioned chewable tablet may also comprise a sweetener, preferably aspartame.
De préférence, les comprimés de l'invention sont pellicules, en associant un édulcorant dans leur formulation, ce qui entraîne une salivation au moment de la prise et permet donc une meilleure absorption et réduit au maximum les inconvénients du calcium.Preferably, the tablets of the invention are dandruff, by associating a sweetener in their formulation, which causes salivation at the time of setting and thus allows better absorption and minimizes the disadvantages of calcium.
Ce pelliculage permet aussi un meilleur aspect des comprimés souvent présentés en tube et évite la formation de poussière de calcium dans le packaging.This film coating also allows a better appearance of the tablets often presented in tube and avoids the formation of calcium dust in the packaging.
Un comprimé particulièrement préféré selon l'invention présente la composition suivante :A particularly preferred tablet according to the invention has the following composition:
Carbonate de calcium 1 250 mgCalcium carbonate 1,250 mg
Poudre de cacao 250 mg250 mg cocoa powder
Sorbitol 200 mgSorbitol 200 mg
Polyvidone 30 mg Aspartam 2 mgPolyvidone 30 mg Aspartam 2 mg
Arôme noisette 14 mgHazelnut aroma 14 mg
Talc 10 mgTalc 10 mg
Stéarate de magnésium 4 mqMagnesium stearate 4 mq
Total 1 760 mg Dans le médicament selon la présente invention, la composition pharmaceutique (A) est de préférence sous forme d'une ampoule buvable de vitamine D, notamment de vitamine D3 (cholécalciférol).Total 1,760 mg In the drug according to the present invention, the pharmaceutical composition (A) is preferably in the form of a vitamin D oral ampoule, especially vitamin D3 (cholecalciferol).
Selon un mode de réalisation préféré, la composition pharmaceutique (A) susmentionnée comprend de 60 000 Ul à 200 000 Ul de vitamine D, et de préférence de vitamine D3.According to a preferred embodiment, the above-mentioned pharmaceutical composition (A) comprises from 60,000 IU to 200,000 IU of vitamin D, and preferably vitamin D3.
La composition pharmaceutique (A) peut être une composition liquide présentée en ampoules, flacons, capsules molles, ou tout autre contenant permettant de conditionner ou de délivrer une préparation pharmaceutique liquide buvable dont le principe actif principal est de la vitamine D, par exemple le cholécalciférol (vitamine D3).The pharmaceutical composition (A) may be a liquid composition presented in ampoules, flasks, soft capsules, or any other container for packaging or delivering an oral liquid pharmaceutical preparation whose main active ingredient is vitamin D, for example cholecalciferol (vitamin D3).
La présente invention concerne également un kit comprenant :The present invention also relates to a kit comprising:
- un contenant de vitamine D buvable, de préférence vitamine D3, ledit contenant étant notamment un flacon, une ampoule ou une capsule molle, et - des comprimés à croquer à base de calcium.- A container of vitamin D drinkable, preferably vitamin D3, said container being in particular a bottle, an ampoule or a soft capsule, and - chewable tablets based on calcium.
De préférence, les comprimés du kit selon la présente invention sont des comprimés à croquer à base de carbonate de calcium comprenant de la poudre de cacao tels que définis ci-dessus.Preferably, the tablets of the kit according to the present invention are chewable tablets based on calcium carbonate comprising cocoa powder as defined above.
Selon un mode de réalisation particulier, les comprimés comprennent de la poudre de cacao à une teneur comprise de 14% à 30% en poids par rapport au poids total des comprimés.According to one particular embodiment, the tablets comprise cocoa powder containing from 14% to 30% by weight relative to the total weight of the tablets.
De préférence, lesdits comprimés comprennent chacun au moins 70% en poids de carbonate de calcium. De préférence, le comprimé de l'invention comprend 1 250 mg de CaCO3 (pour une masse totale de 1 760 mg de comprimé). Selon un mode de réalisation préféré, dans le kit selon la présente invention, le contenant de vitamine D buvable, notamment ampoule buvable de vitamine D, comprend de 60 000 Ul à 200 000 Ul de vitamine D.Preferably, said tablets each comprise at least 70% by weight of calcium carbonate. Preferably, the tablet of the invention comprises 1250 mg of CaCO 3 (for a total mass of 1760 mg of tablet). According to a preferred embodiment, in the kit according to the present invention, the oral vitamin D container, especially a vitamin D oral ampoule, comprises from 60,000 IU to 200,000 IU of vitamin D.
La présente invention concerne également le kit tel que défini ci-dessus, pour son utilisation pour le traitement et la prévention de l'ostéoporose. Le kit de l'invention permet d'associer les avantages d'une supplémentation conjointe de vitamine D, notamment D3, et de calcium tout en minimisant les problèmes entraînant la non observance des traitements.The present invention also relates to the kit as defined above, for its use for the treatment and prevention of osteoporosis. The kit of the invention allows to combine the benefits of a joint supplementation of vitamin D, especially D3, and calcium while minimizing the problems resulting in non-compliance treatments.
De préférence, le kit de l'invention est constitué de 180 comprimés, notamment de comprimés de Calprimum®, et d'une ampoule buvable de vitamine D, de préférence D3, dosée entre 60 000 Ul et 200 000 Ul. Par exemple, une ampoule de 80 000 Ul représente une supplémentation équivalente à 880 Ul/jour, ce qui est considéré selon les données scientifiques actuelles comme la dose requise pour une supplémentation optimale.Preferably, the kit of the invention consists of 180 tablets, including tablets of Calprimum ® , and a vitamin D oral ampoule, preferably D3, dosed between 60,000 IU and 200,000 IU. For example, an 80,000 IU ampoule represents a supplementation equivalent to 880 IU / day, which is considered according to current scientific data as the dose required for optimal supplementation.
L'ampoule de Vitamine D est à prendre en une prise unique en début de trimestre et les comprimés de calcium sont absorbés à raison de 2 comprimés par jour pendant les 3 mois du trimestre.The ampoule of Vitamin D is to be taken in a single dose at the beginning of the trimester and the calcium tablets are absorbed at the rate of 2 tablets per day during the 3 months of the trimester.
L'intérêt de la supplémentation en vitamine D en une seule dose trimestrielle permet d'éviter que les taux sériques de vitamine D aient un risque de tomber en dessous de la limite de rétrocontrôle de la parathormone. En effet, la vitamine D et la parathormone sont étroitement liées dans la régulation du taux de calcium sanguin. Une carence en vitamine D entraîne une diminution de l'absorption du calcium intestinal et provoque une augmentation de sécrétion de la parathormone qui va favoriser la sortie du calcium osseux pour maintenir le taux de calcium sanguin. En résumé, une carence en vitamine D provoque donc une augmentation de la parathormone ce qui favorise la fragilité osseuse.The benefit of vitamin D supplementation in a single quarterly dose prevents serum vitamin D levels from being at risk of falling below the parathyroid hormone retrocontrol limit. Indeed, vitamin D and parathyroid hormone are closely linked in the regulation of blood calcium levels. Vitamin D deficiency causes a decrease in intestinal calcium absorption and causes an increase in parathyroid hormone secretion that will promote the release of bone calcium to maintain blood calcium levels. In summary, a vitamin D deficiency causes an increase in parathyroid hormone which promotes bone fragility.
Les données scientifiques prouvent que la vitamine D absorbée en une forte dose va se fixer dans les tissus adipeux et sera libérée progressivement dans le but de maintenir un taux sérique optimal permettant une bonne absorption du calcium intestinal sans avoir besoin du calcium osseux (via l'augmentation de parathormone) pour maintenir la calcémie.Scientific evidence shows that vitamin D absorbed in a high dose will bind in adipose tissue and will be released gradually in order to maintain optimal serum levels allowing good absorption of intestinal calcium without the need for bone calcium (via increased parathyroid hormone) to maintain calcemia.
Le maintien de la calcémie (taux de calcium sanguin) est très important physiologiquement car le calcium intervient dans de nombreux mécanismes indispensables au maintien de la bonne santé, notamment la minéralisation osseuse, la coagulation, la contraction musculaire, la transmission nerveuse ou les activités enzymatiques.The maintenance of blood calcium (calcium level) is very important physiologically because calcium is involved in many mechanisms essential to the maintenance of good health, including bone mineralization, coagulation, muscle contraction, nerve transmission or enzymatic activities. .
Ce produit est donc le gage que pendant toute la durée du traitement le calcium amené par la supplémentation est absorbé de façon optimale et surtout, même en cas de non observance du traitement en calcium, la parathormone ne sera pas stimulée de façon anarchique, ce qui perturbe les mécanismes de rétrocontrôle, aboutissant à terme à des fragilités osseuses.This product is therefore the guarantee that throughout the duration of the treatment the calcium brought by the supplementation is absorbed in an optimal way and above all, even in case of non-observance of the calcium treatment, the parathyroid hormone will not be stimulated in an anarchic way, which disrupts feedback mechanisms, eventually leading to bone fragility.
Contrairement au médicament sous forme de kit de la présente invention, l'utilisation des produits existants du marché engendre un risque de sous-dosage en vitamine D en cas de mauvaise observance avérée du traitement. Le médicament de la présente invention permet également de minimiser les inconvénients rencontrés par l'ensemble des traitements disponibles sur le marché :In contrast to the kit drug of the present invention, the use of existing products on the market creates a risk of under-dosing of vitamin D in the event of proven poor compliance with the treatment. The medicament of the present invention also makes it possible to minimize the disadvantages encountered by all the treatments available on the market:
- on peut s'assurer que la prise de vitamine D est réalisée quelle que soit l'observance du traitement par la suite ; - on obtient une augmentation du confort de la supplémentation en calcium grâce aux seuls comprimés de calcium offrant un goût agréable ;- It can be ensured that vitamin D intake is achieved regardless of treatment adherence thereafter; - an increase in the comfort of calcium supplementation is obtained thanks to the only calcium tablets with a pleasant taste;
- ce produit est un produit premium d'une qualité pharmaceutique et « cosmétique » parfaite permettant d'offrir un produit dont l'image est moins « vieillotte » que les produits actuellement sur le marché ; - et ce produit est présenté sous forme d'un pack de traitement innovant permettant de se différencier de l'ensemble des acteurs de la classe thérapeutique. A ce jour, il n'existe pas de « pack » des deux produits, calcium et vitamine D, qui pourtant constitue une réelle innovation thérapeutique.- this product is a premium product with the perfect pharmaceutical and "cosmetic" quality to offer a product whose image is less "antiquated" than the products currently on the market; - and this product is presented in the form of an innovative treatment pack allowing to differentiate itself from all the actors of the therapeutic class. To date, there is no "pack" of the two products, calcium and vitamin D, which is a real therapeutic innovation.
Le médicament de l'invention peut donc être présenté sous forme de kit ou Combi Pack et apporte ainsi une facilité de prescription dans un domaine thérapeutique où le vieillissement de la population et ses conséquences (comme l'ostéoporose par exemple) deviennent un véritable problème de santé publique.The medicament of the invention may therefore be presented in the form of a kit or a Combi Pack and thus provides an ease of prescription in a therapeutic field where the aging of the population and its consequences (such as osteoporosis for example) become a real problem. public health.
Le médicament de l'invention sous forme de « Combi Pack » constitue un traitement préventif. Ainsi, le patient n'est pas "malade" et le traitement devra être pris pendant toute la vie.The medicament of the invention in the form of a "Combi Pack" constitutes a preventive treatment. Thus, the patient is not "sick" and the treatment will have to be taken throughout life.
Ainsi, on comprend bien que le patient ne prendra son traitement que s'il n'est pas trop contraignant.Thus, we understand that the patient will take his treatment if it is not too restrictive.
Il est donc réellement innovant de proposer une solution alternative aux traitements conventionnels qui dans le même temps augmente l'observance, augmente l'efficacité et diminue les effets secondaires.It is therefore really innovative to propose an alternative solution to conventional treatments which at the same time increases compliance, increases effectiveness and reduces side effects.
La présente invention concerne également une méthode de prévention de l'ostéoporose par administration du médicament selon la présente invention.The present invention also relates to a method of preventing osteoporosis by administering the medicament according to the present invention.
Plus exactement, la méthode de prévention selon la présente invention consiste à : - administrer à un patient une dose de vitamine D, de préférence de vitamineMore precisely, the prevention method according to the present invention consists in: administering to a patient a dose of vitamin D, preferably vitamin
D3, à un instant donné (JO) notamment sous forme d'une ampoule buvable à une quantité comprise de 60 000 Ul à 200 000 Ul, etD3, at a given instant (OJ) in particular in the form of a drinkable ampoule at a quantity of from 60,000 IU to 200,000 IU, and
- ensuite à administrer audit patient des comprimés de calcium, de préférence les comprimés tels que définis ci-dessus comprenant de la poudre de cacao, à raison de 2 comprimés par jour pendant 90 jours à compter de JO, - puis à J90 réitérer les deux étapes précédentes.- Next to administer to said patient calcium tablets, preferably tablets as defined above comprising cocoa powder, at a rate of 2 tablets per day for 90 days from OJ, - then J90 repeat the two previous steps.
Le traitement préventif de l'invention présente donc une périodicité trimestrielle.The preventive treatment of the invention therefore has a quarterly periodicity.
La présente invention concerne donc également un médicament comprenant deux compositions pharmaceutiques séparées (A) et (B), la composition pharmaceutique (A) étant à base de vitamine D et la composition pharmaceutique (B) étant un comprimé à croquer à base de carbonate de calcium comprenant de la poudre de cacao, pour une administration séparée dans le temps, la composition pharmaceutique (A) étant administrée avant la composition pharmaceutique (B), pour son utilisation pour la prévention et le traitement de l'ostéoporose, par administration orale le premier jour de chaque trimestre d'une dose de 60 000 Ul à 200 000 Ul de vitamine D puis par administration orale de 2 comprimés par jour tels que définis ci-dessus comprenant de la poudre de cacao tous les jours pendant les jours suivants du trimestre. Le "Combi-Pack" selon la présente invention peut être présenté comme suit : un packaging adapté permettant d'accueillir dans une même boîte ou contenant, une ampoule buvable, un flacon, une capsule molle d'une contenance de 2 à 10 ml (plus spécifiquement 2 ml) ainsi que 1 à 9 tubes, flacons, blisters ou tout autre contenant permettant d'accueillir le nombre de comprimés nécessaires au traitement par exemple 90 ou 180 comprimés de carbonate, ascorbate, gluconate, chlorure de Calcium, ou tout autre sel de calcium, par exemple le carbonate de calcium, et permettant d'administrer une quantité de calcium comprise de 250 mg à 2 g de calcium, par exemple 500 mg ou 1 g.The present invention therefore also relates to a medicament comprising two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition (A) being based on vitamin D and the pharmaceutical composition (B) being a chewable tablet based on calcium comprising cocoa powder, for a separate administration in time, the pharmaceutical composition (A) being administered before the pharmaceutical composition (B), for its use for the prevention and treatment of osteoporosis, by oral administration on first day of each trimester of a dose of 60,000 IU to 200,000 IU of vitamin D and then by oral administration of 2 tablets per day as defined above comprising cocoa powder every day during the following days of the trimester . The "Combi-Pack" according to the present invention may be presented as follows: a suitable packaging for accommodating in a same box or container, a drinkable ampoule, a bottle, a soft capsule with a capacity of 2 to 10 ml ( more specifically 2 ml) and 1 to 9 tubes, vials, blisters or any other container to accommodate the number of tablets needed for treatment, for example 90 or 180 tablets of carbonate, ascorbate, gluconate, calcium chloride, or any other calcium salt, for example calcium carbonate, and for administering an amount of calcium of 250 mg to 2 g of calcium, for example 500 mg or 1 g.
La présente invention concerne également un médicament comprenant deux compositions pharmaceutiques séparées (A) et (B), la composition pharmaceutique (A) étant à base de vitamine D et la composition pharmaceutique (B) étant un comprimé à croquer à base de carbonate de calcium comprenant de la poudre de cacao, pour une administration séparée dans le temps, la composition pharmaceutique (A) étant administrée avant la composition pharmaceutique (B), pour son utilisation pour la prévention et le traitement de l'ostéoporose, par administration orale le premier jour de chaque trimestre d'une dose de 60 000 Ul à 200 000 Ul de vitamine D puis par administration orale d'une dose de 500 mg à 1 500 mg de calcium tous les jours pendant les jours suivants du trimestre. Ce régime d'administration consiste à administrer à un patient une dose de vitamine D, de préférence de vitamine D3, à un instant donné (JO) notamment sous forme d'une ampoule buvable à une quantité comprise de 60 000 Ul à 200 000 Ul.The present invention also relates to a medicament comprising two separate pharmaceutical compositions (A) and (B), the pharmaceutical composition (A) being based on vitamin D and the pharmaceutical composition (B) being a chewable tablet based on calcium carbonate comprising cocoa powder, for a separate administration in time, the pharmaceutical composition (A) being administered before the pharmaceutical composition (B), for its use for the prevention and treatment of osteoporosis, by oral administration the first each quarter a dose of 60,000 IU to 200,000 IU of vitamin D, followed by oral administration of 500 mg to 1,500 mg of calcium daily for the following days of the trimester. This administration regime consists of administering to a patient a dose of vitamin D, preferably vitamin D3, at a given instant (OJ), in particular in the form of a drinkable ampoule at a quantity of from 60,000 IU to 200,000 IU. .
Ensuite, on administre audit patient des comprimés de calcium tels que définis ci-dessus comprenant de la poudre de cacao, à raison de 500 mg à 1 500 mg de calcium par jour à compter de JO pendant les jours suivants du trimestre.Then, said patient is administered calcium tablets as defined above comprising cocoa powder, at a rate of 500 mg to 1500 mg of calcium per day starting from OJ during the following days of the trimester.
Enfin, ces deux étapes d'administration sont réitérées en début de chaque trimestre.Finally, these two stages of administration are repeated at the beginning of each quarter.
La présente invention concerne également une méthode de prévention et/ou de traitement de l'ostéoporose, consistant à :The present invention also relates to a method for preventing and / or treating osteoporosis, comprising:
- administrer à un patient le premier jour de chaque trimestre une dose de vitamine D, de préférence de vitamine D3, notamment sous forme d'une ampoule buvable à une quantité comprise de 60 000 Ul à 200 000 Ul, - ensuite à administrer audit patient pendant les jours suivants du trimestre des comprimés de calcium, de préférence les comprimés tels que définis ci-dessus comprenant de la poudre de cacao, à raison de 500 mg à 1 500 mg de calcium par jour. administering to a patient on the first day of each trimester a dose of vitamin D, preferably vitamin D3, in particular in the form of a drinkable ampoule in an amount of from 60,000 IU to 200,000 IU, then to be administered to said patient during the following days of the trimester calcium tablets, preferably the tablets as defined above comprising cocoa powder, at a rate of 500 mg to 1500 mg of calcium per day.
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0953380A FR2945748A1 (en) | 2009-05-20 | 2009-05-20 | DRUG BASED ON CALCIUM AND VITAMIN D. |
| FR0953380 | 2009-05-20 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2010133793A1 true WO2010133793A1 (en) | 2010-11-25 |
Family
ID=41299133
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/FR2010/050947 Ceased WO2010133793A1 (en) | 2009-05-20 | 2010-05-17 | Drug containing calcium and vitamin d |
Country Status (3)
| Country | Link |
|---|---|
| AR (1) | AR076916A1 (en) |
| FR (1) | FR2945748A1 (en) |
| WO (1) | WO2010133793A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2875820A4 (en) * | 2012-04-19 | 2016-01-27 | Obshestvo S Ogranichennoj Otvetstvennostju Parafarm | PREPARATION AND METHOD FOR PROPHYLAXIS AND TREATMENT OF OSTEOPOROSIS AND BONE FRACTURES |
| CN106727675A (en) * | 2015-11-24 | 2017-05-31 | 广东燕岭生命科技股份有限公司 | A kind of calcium-replenishing soft capsule and preparation method thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111494408B (en) * | 2020-04-28 | 2022-04-12 | 广东润源中天生物科技有限公司 | Calcium vitamin D3 tablet and production method thereof |
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| EP2875820A4 (en) * | 2012-04-19 | 2016-01-27 | Obshestvo S Ogranichennoj Otvetstvennostju Parafarm | PREPARATION AND METHOD FOR PROPHYLAXIS AND TREATMENT OF OSTEOPOROSIS AND BONE FRACTURES |
| AU2012377478B2 (en) * | 2012-04-19 | 2017-07-06 | Obschestvo S Organichennoj Otvetstvennost'ju "Parafarm" | Preparation and method for the prophylaxis and treatment of osteoporosis and bone fractures |
| CN106727675A (en) * | 2015-11-24 | 2017-05-31 | 广东燕岭生命科技股份有限公司 | A kind of calcium-replenishing soft capsule and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| AR076916A1 (en) | 2011-07-20 |
| FR2945748A1 (en) | 2010-11-26 |
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