WO2007048811A1 - Pharmaceutical compositions comprising tricalcium phosphate and calcium carbonate - Google Patents

Pharmaceutical compositions comprising tricalcium phosphate and calcium carbonate Download PDF

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Publication number
WO2007048811A1
WO2007048811A1 PCT/EP2006/067773 EP2006067773W WO2007048811A1 WO 2007048811 A1 WO2007048811 A1 WO 2007048811A1 EP 2006067773 W EP2006067773 W EP 2006067773W WO 2007048811 A1 WO2007048811 A1 WO 2007048811A1
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Prior art keywords
calcium
tricalcium phosphate
calcium carbonate
elementary
chewable tablets
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PCT/EP2006/067773
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French (fr)
Inventor
Giovanna Marzano
Isabelle Rault
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Novartis Ag
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • 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
    • A61K33/42—Phosphorus; Compounds thereof

Definitions

  • the present invention concerns calcium supplements, more specifically chewable tablets comprising calcium.
  • "Calcium” typically means calcium in salt form, i.e. in ionic form, namely as Ca(2+). Calcium supplements are widely being used as mineral supplements e.g. to maintain and increase bone density in the prevention of osteoporosis, e.g. in postmenopausal women.
  • Chewable tablets comprising calcium are known in the art. One reason for using them is that the normal dosages of calcium required would make an - ordinary, immediately swallowable - tablet very large and therefore difficult to swallow. Chewable tablets also have the advantage of providing a rapid delivery system without the use of any liquid e.g. water.
  • the chewing action and residence in the mouth makes the taste of the active substances and other excipients a factor in its acceptability for the patient.
  • the active substances and excipients for chewable tablets are chosen not only as appropriate for the dose form, but also to provide the best possible aesthetics for the compositions, including texture, flavor, after-taste, etc.
  • Calcium supplements and nutritional supplements comprising calcium - including those in the form of a chewable tablet - typically comprise calcium in the form of calcium salts, e.g. as calcium carbonate, a calcium phosphate salt, calcium gluconate, calcium lactate, calcium lactate gluconate or calcium citrate.
  • a "calcium phosphate salt” is e.g. monocalcium phosphate, anhydrous dicalcium phosphate, dicalcium phosphate dihydrate or tricalcium phosphate.
  • the goal is to provide the patient not only with an appropriate amount of calcium but also with a substantial amount of the recommended daily dose of elementary phosphorus (700 mg), preferably at least 15% thereof (105 mg) and in particular at least 20% thereof (140 mg), at the same time.
  • elementary phosphorus 700 mg
  • this could be achieved, in principle, by using a calcium phosphate salt.
  • the above mentioned drawbacks regarding the aesthetics of calcium chewable tablets - especially unsatisfying mouthfeel, chalkiness, roughness and dustiness - are particularly pronounced when using calcium phosphate salts as a combined calcium and phosphorus source.
  • the invention therefore concerns a chewable tablet comprising tricalcium phosphate and calcium carbonate,
  • Tricalcium phosphate is a well recognized and widely commercially available substance, e.g. under the trade names and Calipharm T®, TCP-DCTM or Tri-Tab® (all of Rhodia, USA) or as tricalcium phosphate powder.
  • tricalcium phosphate includes all materials which are complying with the specifications of the United States Pharmacopeia (USP 28, “Tribasic Calcium Phosphate") or those of the European Pharmacopoeia (Ph. Eur. 5.2, "Calcium Phosphate”).
  • the empirical formulae given there are 10 CaO-SP 2 O 5 -H 2 O and Ca 5 (OH)(PO 4 ) 3 .
  • Calcium carbonate has the molecular formula CaCO 3 . It is a widely commercially available substance, e.g under the trade names Destab 95 MD Ultra 250® and Destab 95 AHD Ultra 250®.
  • the amount of calcium in the chewable tablet, calculated as elementary calcium is 300 to 1300 mg, especially 500 to 1200 mg, more especially 600 to 1000 mg, in particular 600 to 800 mg; or 300 to 800 mg.
  • tricalcium phosphate and calcium carbonate are present in a weight ratio of 40:60 to 70:30, especially 40:60 to 60:40 and in particular 50:50 to 60:40.
  • the chewable tablets of the invention comprise usual excipients as known in the art, for example sweeteners, e.g. isomalt, mannitol, xylitol, aspartame or acesulfame K, and flavors, e.g. orange or lemon flavors.
  • sweeteners e.g. isomalt, mannitol, xylitol, aspartame or acesulfame K
  • flavors e.g. orange or lemon flavors.
  • the beneficial properties of the chewable tablets of the invention are demonstrated e.g. by carrying out sensory evaluation tests with volunteers in randomized studies.
  • the texture of the tablets is appreciated as being either very good, good, acceptable, bad or very bad.
  • the chewable tablets of the invention reach high ratings, e.g. between 75 and more than 95% of accumulated "very good/good/acceptable" and up to 75% of accumulated "very good/good” appraisals.
  • Examples Examples 1-3 Chewable tablets comprising 600 mg Ca
  • Examples 4-6 Chewable tablets comprising 600 mg Ca and 10 micrograms of Vitamin D3
  • Examples 11-14 Chewable tablets comprising 600 mg Ca [and further 10 micrograms of Vitamin D3 in Examples 11-13]
  • the chewable tablets are manufactured as follows.
  • Method 1 (batch size 12.6 kg) for Examples 1 , 3, 8 and 10: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate (a), calcium carbonate, xylitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
  • Method 2 (batch size 12.6 kg) for Examples 4 and 13: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate(a), the dispersion of cholecalciferol, calcium carbonate, xylitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine
  • Method 3 (batch size 12.6 kg) for Examples 2, 7 and 9: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients:The granulate(a), calcium carbonate, isomalt, mannitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
  • Method 4 (batch size 12.6 kg) for Examples 5-6 and 11-12: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate(a), the dispersion of cholecalciferol, calcium carbonate, isomalt, mannitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
  • Method 5 (batch size 12.6 kg) for Example 14: Introduce into a container the following ingredients: calcium carbonate, tricalcium phosphate, isomalt, mannitol, aspartame, acesulfam K, orange flavor, citric acid monohydrate and sodium chloride. Then the mixture is mixed using a container. Magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to chewable tablets comprising tricalcium phosphate and calcium carbonate in a certain weight ratio. Said chewable tablets are characterized by an excellent mouthfeel and palatability.

Description

PHARMACEUTICAL COMPOSITIONS COMPRISING TRICALCIUM PHOSPHATE AND CALCIUM
CARBONATE
The present invention concerns calcium supplements, more specifically chewable tablets comprising calcium. "Calcium" typically means calcium in salt form, i.e. in ionic form, namely as Ca(2+). Calcium supplements are widely being used as mineral supplements e.g. to maintain and increase bone density in the prevention of osteoporosis, e.g. in postmenopausal women.
Chewable tablets comprising calcium are known in the art. One reason for using them is that the normal dosages of calcium required would make an - ordinary, immediately swallowable - tablet very large and therefore difficult to swallow. Chewable tablets also have the advantage of providing a rapid delivery system without the use of any liquid e.g. water.
However, one of the issues for chewable tablets which is circumvented by the ordinary swallowable tablet is that the chewing action and residence in the mouth makes the taste of the active substances and other excipients a factor in its acceptability for the patient. More generally, the active substances and excipients for chewable tablets are chosen not only as appropriate for the dose form, but also to provide the best possible aesthetics for the compositions, including texture, flavor, after-taste, etc.
In spite of the large amount of research directed to providing aesthetically-acceptable calcium chewable tablet compositions, there continues to be a need for compositions which have further improvements in aesthetics. Typical complaints by patients include "chalky mouthfeel"; "poor intrabuccal sensations" causing marked discomfort, especially roughness or dustiness, during or after ingestion; "boring and disgusting sensation" upon chewing, and so forth.
Thus, it is an object of the present invention to provide chewable calcium tablet compositions containing a level of calcium useful as calcium supplement which are recognized as having improved aesthetics, in particular improved palatability.
Calcium supplements and nutritional supplements comprising calcium - including those in the form of a chewable tablet - typically comprise calcium in the form of calcium salts, e.g. as calcium carbonate, a calcium phosphate salt, calcium gluconate, calcium lactate, calcium lactate gluconate or calcium citrate. A "calcium phosphate salt" is e.g. monocalcium phosphate, anhydrous dicalcium phosphate, dicalcium phosphate dihydrate or tricalcium phosphate.
In a particular embodiment of the invention, the goal is to provide the patient not only with an appropriate amount of calcium but also with a substantial amount of the recommended daily dose of elementary phosphorus (700 mg), preferably at least 15% thereof (105 mg) and in particular at least 20% thereof (140 mg), at the same time. Obviously, this could be achieved, in principle, by using a calcium phosphate salt. Unfortunately, however, the above mentioned drawbacks regarding the aesthetics of calcium chewable tablets - especially unsatisfying mouthfeel, chalkiness, roughness and dustiness - are particularly pronounced when using calcium phosphate salts as a combined calcium and phosphorus source. Thus, it is another object of the invention to provide calcium chewable tablets which comprise a calcium phosphate salt as a combined calcium and phosphorus source, and which nevertheless have good aesthetics.
It has now been found, surprisingly, that when combining tricalcium phosphate with calcium carbonate at a certain ratio in a chewable tablet, the aesthetics thereof, especially mouthfeel and palatability, are substantially improved.
The invention therefore concerns a chewable tablet comprising tricalcium phosphate and calcium carbonate,
(a) wherein calcium, calculated as elementary calcium, is present in amount of 250 to 1500 mg, and
(b) wherein the weight ratio of elementary calcium provided by tricalcium phosphate to elementary calcium provided by calcium carbonate is from 30:70 to 70:30.
Tricalcium phosphate is a well recognized and widely commercially available substance, e.g. under the trade names and Calipharm T®, TCP-DC™ or Tri-Tab® (all of Rhodia, USA) or as tricalcium phosphate powder. In particular, "tricalcium phosphate" includes all materials which are complying with the specifications of the United States Pharmacopeia (USP 28, "Tribasic Calcium Phosphate") or those of the European Pharmacopoeia (Ph. Eur. 5.2, "Calcium Phosphate"). The empirical formulae given there are 10 CaO-SP2O5-H2O and Ca5(OH)(PO4)3. Tricalcium phosphate has also been frequently described as tricalcium (di)orthophosphate [= Ca3(PO4J2], see e.g. The Merck Index, 12th Ed., No. 1741 , Whitehouse Station, NJ, USA 1996.
Calcium carbonate has the molecular formula CaCO3. It is a widely commercially available substance, e.g under the trade names Destab 95 MD Ultra 250® and Destab 95 AHD Ultra 250®.
Preferably, the amount of calcium in the chewable tablet, calculated as elementary calcium, is 300 to 1300 mg, especially 500 to 1200 mg, more especially 600 to 1000 mg, in particular 600 to 800 mg; or 300 to 800 mg.
Preferably, tricalcium phosphate and calcium carbonate are present in a weight ratio of 40:60 to 70:30, especially 40:60 to 60:40 and in particular 50:50 to 60:40.
Moreover, the chewable tablets of the invention comprise usual excipients as known in the art, for example sweeteners, e.g. isomalt, mannitol, xylitol, aspartame or acesulfame K, and flavors, e.g. orange or lemon flavors.
The beneficial properties of the chewable tablets of the invention are demonstrated e.g. by carrying out sensory evaluation tests with volunteers in randomized studies. The texture of the tablets is appreciated as being either very good, good, acceptable, bad or very bad. The chewable tablets of the invention reach high ratings, e.g. between 75 and more than 95% of accumulated "very good/good/acceptable" and up to 75% of accumulated "very good/good" appraisals.
Examples Examples 1-3: Chewable tablets comprising 600 mg Ca
Figure imgf000005_0001
Examples 4-6: Chewable tablets comprising 600 mg Ca and 10 micrograms of Vitamin D3
Figure imgf000006_0001
Examples 7-10: Chewable tablets comprising 600 mg Ca
Figure imgf000007_0001
Examples 11-14: Chewable tablets comprising 600 mg Ca [and further 10 micrograms of Vitamin D3 in Examples 11-13]
Figure imgf000008_0001
The chewable tablets are manufactured as follows.
Method 1 (batch size 12.6 kg) for Examples 1 , 3, 8 and 10: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate (a), calcium carbonate, xylitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
Method 2 (batch size 12.6 kg) for Examples 4 and 13: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate(a), the dispersion of cholecalciferol, calcium carbonate, xylitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine
Method 3 (batch size 12.6 kg) for Examples 2, 7 and 9: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients:The granulate(a), calcium carbonate, isomalt, mannitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. The mixture is mixed using a container blender. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
Method 4 (batch size 12.6 kg) for Examples 5-6 and 11-12: Introduce into a high-speed mixer/granulator tricalcium phosphate and Povidone K-30 and mix. Then purified water is added. Mix again. The wet granulate is dried using a fluid bed dryer [granulate(a)]. Introduce into a container the following ingredients: The granulate(a), the dispersion of cholecalciferol, calcium carbonate, isomalt, mannitol, croscarmellose sodium, aspartame, acesulfam K, orange flavor, citric acid and sodium chloride. Then magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.
Method 5 (batch size 12.6 kg) for Example 14: Introduce into a container the following ingredients: calcium carbonate, tricalcium phosphate, isomalt, mannitol, aspartame, acesulfam K, orange flavor, citric acid monohydrate and sodium chloride. Then the mixture is mixed using a container. Magnesium stearate is added and the mixture is mixed again. The final mixture is compressed into tablet using a rotating tabletting machine.

Claims

Claims
1. A chewable tablet comprising tricalcium phosphate and calcium carbonate,
(a) wherein calcium, calculated as elementary calcium, is present in amount of 250 to 1500 mg, and
(b) wherein the weight ratio of elementary calcium provided by tricalcium phosphate to elementary calcium provided by calcium carbonate is from 30:70 to 70:30.
2. A chewable tablet according to claim 1 , wherein calcium, calculated as elementary calcium, is present in amount of 300 to 1300 mg.
3. A chewable tablet according to claim 1 , wherein calcium, calculated as elementary calcium, is present in amount of 300 to 800 mg.
4. A chewable tablet according to any one of claims 1-3, wherein the weight ratio of elementary calcium provided by tricalcium phosphate to elementary calcium provided by calcium carbonate is from 40:60 to 70:30.
5. A chewable tablet according to any one of claims 1-4, which comprises Vitamin D3.
6. A chewable tablet according to claim 5, which comprises Vitamin D3 in an amount of 5 to 15 micrograms.
7. A chewable tablet according to any one of claims 1-6, which comprises at least 105 mg of elementary phosphorus.
PCT/EP2006/067773 2005-10-28 2006-10-25 Pharmaceutical compositions comprising tricalcium phosphate and calcium carbonate WO2007048811A1 (en)

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Cited By (7)

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GR1007316B (en) * 2010-05-31 2011-06-14 Uni-Pharma Κλεων Τσετης Φαρμακευτικα Εργαστηρια Αβεε Με Δ.Τ. Uni-Pharma Abee, Pharmaceutical composition of carbon calcium tablets
US20120004157A1 (en) * 2007-06-08 2012-01-05 Bergen Teknologioverforing As Hydroxyproline compositions and uses thereof
WO2013088440A1 (en) * 2011-12-13 2013-06-20 Amorphical Ltd. Amorphous calcium carbonate for the treatment of calcium malabsorption and metabolic bone disorders
WO2014122658A1 (en) * 2013-02-11 2014-08-14 Amorphical Ltd. Amorphous calcium carbonate for accelerated bone growth
WO2016016895A1 (en) * 2014-07-31 2016-02-04 Amorphical Ltd. Non-aqueous liquid and semi-solid formulations of amorphous calcium carbonate
US11052108B2 (en) 2016-10-25 2021-07-06 Amorphical Ltd. Amorphous calcium carbonate for treating a leukemia
US11052107B2 (en) 2015-06-04 2021-07-06 Amorphical Ltd. Amorphous calcium carbonate stabilized with polyphosphates or bisphosphonates

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US20030031726A1 (en) * 2001-08-09 2003-02-13 Lewis Hendricks Calcium dietary supplement
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US4327076A (en) * 1980-11-17 1982-04-27 Life Savers, Inc. Compressed chewable antacid tablet and method for forming same
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US20040180097A1 (en) * 2003-03-13 2004-09-16 Nanotrend Ino-Tech Inc. Stable and taste masked pharmaceutical dosage form using porous apatite grains

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120004157A1 (en) * 2007-06-08 2012-01-05 Bergen Teknologioverforing As Hydroxyproline compositions and uses thereof
GR1007316B (en) * 2010-05-31 2011-06-14 Uni-Pharma Κλεων Τσετης Φαρμακευτικα Εργαστηρια Αβεε Με Δ.Τ. Uni-Pharma Abee, Pharmaceutical composition of carbon calcium tablets
WO2013088440A1 (en) * 2011-12-13 2013-06-20 Amorphical Ltd. Amorphous calcium carbonate for the treatment of calcium malabsorption and metabolic bone disorders
US10064890B2 (en) 2011-12-13 2018-09-04 Amorphical Ltd. Amorphous calcium carbonate for the treatment of calcium malabsorption and metabolic bone disorders
US10688124B2 (en) 2011-12-13 2020-06-23 Amorphical Ltd Amorphous calcium carbonate for the treatment of calcium malabsorption and metabolic bone disorders
WO2014122658A1 (en) * 2013-02-11 2014-08-14 Amorphical Ltd. Amorphous calcium carbonate for accelerated bone growth
CN105007925A (en) * 2013-02-11 2015-10-28 艾玛菲克有限公司 Amorphous calcium carbonate for accelerated bone growth
WO2016016895A1 (en) * 2014-07-31 2016-02-04 Amorphical Ltd. Non-aqueous liquid and semi-solid formulations of amorphous calcium carbonate
US11602542B2 (en) 2014-07-31 2023-03-14 Amorphical Ltd. Non-aqueous liquid and semi-solid formulations of amorphous calcium carbonate
US11052107B2 (en) 2015-06-04 2021-07-06 Amorphical Ltd. Amorphous calcium carbonate stabilized with polyphosphates or bisphosphonates
US12115184B2 (en) 2015-06-04 2024-10-15 Amorphical Ltd. Amorphous calcium carbonate stabilized with polyphosphates or bisphosphonates
US11052108B2 (en) 2016-10-25 2021-07-06 Amorphical Ltd. Amorphous calcium carbonate for treating a leukemia

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