ES1286975U - Compressed containing 25-Oh vitamin D3 (Machine-translation by Google Translate, not legally binding) - Google Patents
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- ES1286975U ES1286975U ES202130151U ES202130151U ES1286975U ES 1286975 U ES1286975 U ES 1286975U ES 202130151 U ES202130151 U ES 202130151U ES 202130151 U ES202130151 U ES 202130151U ES 1286975 U ES1286975 U ES 1286975U
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- JWUBBDSIWDLEOM-UHFFFAOYSA-N 25-Hydroxycholecalciferol Natural products C1CCC2(C)C(C(CCCC(C)(C)O)C)CCC2C1=CC=C1CC(O)CCC1=C JWUBBDSIWDLEOM-UHFFFAOYSA-N 0.000 title claims abstract description 15
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 10
- JWUBBDSIWDLEOM-DCHLRESJSA-N 25-Hydroxyvitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C/C=C1\C[C@@H](O)CCC1=C JWUBBDSIWDLEOM-DCHLRESJSA-N 0.000 claims abstract description 9
- JWUBBDSIWDLEOM-NQZHSCJISA-N 25-hydroxy-3 epi cholecalciferol Chemical compound C1([C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=CC=C1C[C@H](O)CCC1=C JWUBBDSIWDLEOM-NQZHSCJISA-N 0.000 claims abstract description 9
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 16
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 10
- 239000000843 powder Substances 0.000 claims description 8
- 239000000377 silicon dioxide Substances 0.000 claims description 8
- 229960001866 silicon dioxide Drugs 0.000 claims description 8
- 235000012239 silicon dioxide Nutrition 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 7
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 7
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 7
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 7
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 6
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 6
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 claims description 6
- 229960000913 crospovidone Drugs 0.000 claims description 6
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 6
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 6
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 5
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 5
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims description 5
- 239000011627 DL-alpha-tocopherol Substances 0.000 claims description 2
- 235000001815 DL-alpha-tocopherol Nutrition 0.000 claims description 2
- 229920000881 Modified starch Polymers 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 239000011230 binding agent Substances 0.000 claims description 2
- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 2
- 239000007884 disintegrant Substances 0.000 claims description 2
- -1 fluidizers Substances 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 229940057948 magnesium stearate Drugs 0.000 claims description 2
- 229940057917 medium chain triglycerides Drugs 0.000 claims description 2
- 229960005055 sodium ascorbate Drugs 0.000 claims description 2
- 235000010378 sodium ascorbate Nutrition 0.000 claims description 2
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims description 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims description 2
- 239000005720 sucrose Substances 0.000 claims description 2
- 229960004793 sucrose Drugs 0.000 claims description 2
- 229960000984 tocofersolan Drugs 0.000 claims description 2
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- JWUBBDSIWDLEOM-DTOXIADCSA-N calcidiol Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C\C=C1\C[C@@H](O)CCC1=C JWUBBDSIWDLEOM-DTOXIADCSA-N 0.000 description 22
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 description 5
- 239000000203 mixture Substances 0.000 description 5
- 235000021318 Calcifediol Nutrition 0.000 description 4
- 229960004361 calcifediol Drugs 0.000 description 4
- 235000005911 diet Nutrition 0.000 description 4
- 239000008194 pharmaceutical composition Substances 0.000 description 4
- 230000000378 dietary effect Effects 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000007901 soft capsule Substances 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 235000005282 vitamin D3 Nutrition 0.000 description 3
- 239000011647 vitamin D3 Substances 0.000 description 3
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 3
- 229940021056 vitamin d3 Drugs 0.000 description 3
- 229930003316 Vitamin D Natural products 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 235000019166 vitamin D Nutrition 0.000 description 2
- 239000011710 vitamin D Substances 0.000 description 2
- 150000003710 vitamin D derivatives Chemical class 0.000 description 2
- 229940046008 vitamin d Drugs 0.000 description 2
- 208000013725 Chronic Kidney Disease-Mineral and Bone disease Diseases 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 206010025476 Malabsorption Diseases 0.000 description 1
- 208000004155 Malabsorption Syndromes Diseases 0.000 description 1
- 208000001132 Osteoporosis Diseases 0.000 description 1
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 230000004097 bone metabolism Effects 0.000 description 1
- 239000004067 bulking agent Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 230000003750 conditioning effect Effects 0.000 description 1
- 239000003246 corticosteroid Substances 0.000 description 1
- 229960001334 corticosteroids Drugs 0.000 description 1
- 229960005168 croscarmellose Drugs 0.000 description 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000018823 dietary intake Nutrition 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000001007 flame atomic emission spectroscopy Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 230000003054 hormonal effect Effects 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 201000006409 renal osteodystrophy Diseases 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 230000036561 sun exposure Effects 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- FIAFUQMPZJWCLV-UHFFFAOYSA-N suramin Chemical compound OS(=O)(=O)C1=CC(S(O)(=O)=O)=C2C(NC(=O)C3=CC=C(C(=C3)NC(=O)C=3C=C(NC(=O)NC=4C=C(C=CC=4)C(=O)NC=4C(=CC=C(C=4)C(=O)NC=4C5=C(C=C(C=C5C(=CC=4)S(O)(=O)=O)S(O)(=O)=O)S(O)(=O)=O)C)C=CC=3)C)=CC=C(S(O)(=O)=O)C2=C1 FIAFUQMPZJWCLV-UHFFFAOYSA-N 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
Description
DESCRIPCIÓNDESCRIPTION
Comprimido que contiene 25-OH vitamina D3Tablet containing 25-OH vitamin D3
Breve descripción de la invenciónBrief description of the invention
La presente invención se refiere a una nueva composición que comprende 25-hidroxivitamina D3 ("25(OH)D3"). Esta composición está destinada al uso como suplemento dietético, y se puede utilizar para complementar una dieta carente o deficiente en ingesta de vitamina D.The present invention relates to a new composition comprising 25-hydroxyvitamin D3 ("25(OH)D3"). This composition is intended for use as a dietary supplement, and can be used to supplement a diet lacking or deficient in vitamin D intake.
Estado de la técnica anteriorState of the prior art
Se conoce que la vitamina D3 participa en numerosos sistemas fisiológicos, especialmente en el metabolismo óseo. A lo largo de los años también se ha reconocido su papel en varias funciones, incluyendo la regulación de la glucosa, la fuerza muscular, y la inmunidad.Vitamin D3 is known to participate in numerous physiological systems, especially bone metabolism. Over the years, its role in various functions has also been recognized, including glucose regulation, muscle strength, and immunity.
Se conoce que la vitamina D3 es producida por el cuerpo humano en respuesta a la exposición solar. Se metaboliza a 25-hidroxivitamina D3 (también conocida como calcifediol), a la que también se hace referencia como la forma circulante de la vitamina D3. Posteriormente, se metaboliza a 1-alfa-25-dihidroxivitamina D, la forma “activa” u “hormonal” .Vitamin D3 is known to be produced by the human body in response to sun exposure. It is metabolized to 25-hydroxyvitamin D3 (also known as calcifediol), which is also referred to as the circulating form of vitamin D3. Subsequently, it is metabolized to 1-alpha-25-dihydroxyvitamin D, the “active” or “hormonal” form.
Se conocen algunas formulaciones orales de 25-hidroxivitamina D3 ("25(OH)D3") en el estado de la técnica, aunque se trata de composiciones fundamentalmente farmacéuticas. En este sentido, se conoce ampliamente que las cantidades de 25(OH)D3 utilizadas en composiciones farmacéuticas, con un fin terapéutico, son claramente superiores a las cantidades de 25(OH)D3 para uso dietético o alimentario.Some oral formulations of 25-hydroxyvitamin D3 ("25(OH)D3") are known in the state of the art, although they are essentially pharmaceutical compositions. In this sense, it is widely known that the amounts of 25(OH)D3 used in pharmaceutical compositions, for therapeutic purposes, are clearly higher than the amounts of 25(OH)D3 for dietary or food use.
Específicamente, de acuerdo con la Opinión Científica establecida por la EFSA (European Food Safety Authority) en 2012 respecto al límite superior tolerable de ingesta de vitamina D a través de productos dietéticos y nutrición, la dosis máxima recomendada es de 100 microgramos/día de 25(OH)D3 para adultos, 50 microgramos/día de 25(OH)D3 para niños de 1-10 años, y 25 microgramos/día de 25(OH)D3 para niños menores de 10 años. Sin embargo, las formulaciones farmacéuticas contienen cantidades significativamente superiores de 25(OH)D3: por ejemplo, la formulación líquida comercial HIDROFEROL (FAES Farma, España), destinada al tratamiento de osteoporosis, osteodistrofía renal, problemas óseos derivados del tratamiento previo con corticoides, o el tratamiento en pacientes con síndrome de malabsorción, contiene 266 microgramos (16.000 UI) de 25(OH)D3, una cantidad significativamente superior a la dosis máxima recomendada para la ingesta dietética o alimentaria.Specifically, according to the Scientific Opinion established by the EFSA ( European Food Safety Authority) in 2012 regarding the tolerable upper limit of vitamin D intake through dietary products and nutrition, the maximum recommended dose is 100 micrograms/day of 25 (OH)D3 for adults, 25(OH)D3 50 micrograms/day for children 1-10 years, and 25(OH)D3 25 micrograms/day for children under 10 years. However, pharmaceutical formulations contain significantly higher amounts of 25(OH)D3: for example, the commercial liquid formulation HIDROFEROL (FAES Farma, Spain), intended for the treatment of osteoporosis, renal osteodystrophy, bone problems derived from previous treatment with corticosteroids, or treatment in patients with syndrome of malabsorption, contains 266 micrograms (16,000 IU) of 25(OH)D3, an amount significantly higher than the maximum recommended dose for dietary or dietary intake.
En US 10,525,018 se describe una cápsula blanda que contiene una composición farmacéutica libre de ceras que a su vez comprende 25(OH)D3, un componente oleoso y un disolvente orgánico. Sin embargo, se conoce que las formulaciones en forma de cápsula blanda presentan habitualmente una elevada sensibilidad frente a las condiciones ambientales (p. ej. humedad), por lo que presentan una vida útil (shelf-life) relativamente corta. Además, el coste de fabricación de dichas cápsulas blandas suele ser más elevado en comparación con otras formas farmacéuticas.US 10,525,018 describes a soft capsule containing a wax-free pharmaceutical composition which in turn comprises 25(OH)D3, an oily component and an organic solvent. However, it is known that formulations in soft capsule form usually have a high sensitivity to environmental conditions (eg humidity), so they have a relatively short shelf-life . In addition, the manufacturing cost of said soft capsules is usually higher compared to other pharmaceutical forms.
Descripción detallada de la invenciónDetailed description of the invention
La presente invención se refiere a una formulación en forma de comprimido de 25(OH)D3, que comprende hasta 25 microgramos de 25(OH)D3, preferentemente hasta 10 microgramos de 25(OH)D3, y otros excipientes. Este comprimido tiene las ventajas de ser fácil de producir, un tamaño cómodo y una buena homogeneidad del ingrediente que está presente en una concentración baja en el comprimido.The present invention relates to a formulation in tablet form of 25(OH)D3, comprising up to 25 micrograms of 25(OH)D3, preferably up to 10 micrograms of 25(OH)D3, and other excipients. This tablet has the advantages of easy production, convenient size and good homogeneity of the ingredient which is present in a low concentration in the tablet.
En realizaciones preferidas, el comprimido comprende calcifediol secado por pulverización y otros compuestos de excipiente, tales como aglutinantes, agentes de carga, fluidificantes adyuvantes, disgregantes y lubricantes. En realizaciones preferidas, estos se pueden elegir entre: celulosa microcristalina, hidrógeno fosfato de calcio dihidrato, dióxido de silicio, crospovidona, croscarmelosa sódica y estearato de magnesio.In preferred embodiments, the tablet comprises spray-dried calcifediol and other excipient compounds, such as binders, bulking agents, flow aids, disintegrants, and lubricants. In preferred embodiments, these can be chosen from: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, silicon dioxide, crospovidone, croscarmellose sodium, and magnesium stearate.
Los porcentajes preferidos (% en peso) de los excipientes en una gama de comprimidos son los siguientes:Preferred percentages (% by weight) of excipients in a range of tablets are as follows:
• Celulosa microcristalina: el 50-75 %, preferentemente el 60-70 %, más preferentemente el 65-68%. En una realización, es del 67,5 %.• Microcrystalline cellulose: 50-75%, preferably 60-70%, more preferably 65-68%. In one embodiment, it is 67.5%.
• Hidrógeno fosfato de calcio dihidrato: el 18-35 %, preferentemente el 20-30 %, más preferentemente el 24-25%. En una realización, es del 25 %.• Calcium hydrogen phosphate dihydrate: 18-35%, preferably 20-30%, more preferably 24-25%. In one embodiment, it is 25%.
• Dióxido de silicio: el 0,5-2,0 %; preferentemente el 1,0-1,5 %. En una realización, es del 1,3 %.• Silicon dioxide: 0.5-2.0%; preferably 1.0-1.5%. In one embodiment, it is 1.3%.
• Crospovidona: el 0,5-1,0 %. En una realización, es del 0,67 %. • Crospovidone: 0.5-1.0%. In one embodiment, it is 0.67%.
• Croscarmelosa sódica: el 0,5-1 %. En una realización, es del 0,67 %.• Croscarmellose sodium: 0.5-1%. In one embodiment, it is 0.67%.
• Estearato de magnesio: el 1,0-3 %, preferentemente el 1-1,5 %. En una realización, es del 1,3 %.• Magnesium stearate: 1.0-3%, preferably 1-1.5%. In one embodiment, it is 1.3%.
El polvo secado por pulverización que comprende 25(OH)D3, contiene en sí mismo sacarosa, ascorbato de sodio, triglicéridos de cadena media, dióxido de silicio, dl-alfa-tocoferol y almidón alimenticio modificado. El polvo de 25(OH)D3 secado por pulverización está disponible a través de DSM Nutritional Products, Suiza, como "Calcifediol 0,25 % SD/S".The spray dried powder comprising 25(OH)D3, itself contains sucrose, sodium ascorbate, medium chain triglycerides, silicon dioxide, dl-alpha-tocopherol and modified food starch. Spray dried 25(OH)D3 powder is available from DSM Nutritional Products, Switzerland as "Calcifediol 0.25% SD/S".
Un método de preparación del comprimido implica a) obtener un polvo secado por pulverización que comprende 25(OH)D3; b) añadir diversos excipientes para la formación del comprimido; y c) formar un comprimido.One method of tablet preparation involves a) obtaining a spray-dried powder comprising 25(OH)D3; b) adding various excipients for the formation of the tablet; and c) forming a tablet.
La cantidad de 25(OH)D3 en un comprimido individual se puede ajustar según la experiencia del experto habitual.The amount of 25(OH)D3 in an individual tablet can be adjusted according to the experience of the ordinary skilled person.
El comprimido en sí mismo tiene preferentemente un peso final de 75-200 mg. La Tabla 1 del Ejemplo contiene las cantidades finales de los diversos ingredientes del comprimido, tal como se calculan para un comprimido de 150 mg. Estas cantidades se pueden ajustar al alza o a la baja cuando se cambia el tamaño del comprimido.The tablet itself preferably has a final weight of 75-200 mg. Example Table 1 contains the final amounts of the various tablet ingredients, as calculated for a 150 mg tablet. These amounts can be adjusted up or down when changing tablet size.
Preferentemente, el comprimido contiene una cantidad de 25(OH)D3 que puede variar desde 1 microgramo hasta 25 microgramos, preferentemente de 5 a 15 microgramos y más preferentemente 10-13 microgramos. Un comprimido particularmente preferido contiene 10 microgramos y, opcionalmente, una pequeña cantidad (hasta tres microgramos) de "excedente" para garantizar la provisión de 10 microgramos completos.Preferably, the tablet contains an amount of 25(OH)D3 that can vary from 1 microgram to 25 micrograms, preferably from 5 to 15 micrograms and more preferably 10-13 micrograms. A particularly preferred tablet contains 10 micrograms and, optionally, a small amount (up to three micrograms) of "surplus" to ensure provision of the full 10 micrograms.
El siguiente Ejemplo no limitante se presenta para ilustrar adicionalmente la invención.The following non-limiting Example is presented to further illustrate the invention.
EJEMPLO 1EXAMPLE 1
Producción del comprimidoTablet production
Se mezcla polvo de calcifediol al 0,25 % secado por pulverización con una parte de celulosa microcristalina para preparar una premezcla. A esta premezcla se le añade hidrógeno fosfato de calcio dihidrato, dióxido de silicio, crospovidona, croscarmelosa y la celulosa microcristalina restante y se mezclan minuciosamente en una mezcladora de doble cono. El polvo mezclado resultante se transfiere a un recipiente a granel.Spray dried 0.25% calcifediol powder is mixed with a portion of microcrystalline cellulose to prepare a premix. Calcium hydrogen phosphate dihydrate, silicon dioxide, crospovidone, croscarmellose and microcrystalline cellulose are added to this premix. remaining and thoroughly mixed in a double cone mixer. The resulting blended powder is transferred to a bulk container.
El polvo mezclado se comprime en una máquina de compresión de comprimidos para producir comprimidos de núcleo, que se pueden almacenar en un recipiente a granel hasta que se formen las etapas finales de inspección y acondicionamiento.The blended powder is compressed in a tablet compression machine to produce core tablets, which can be stored in a bulk container until the final inspection and conditioning stages are formed.
Un comprimido final (peso total de 150 mg) se detalla en la TABLA 1, a continuación.A final tablet (total weight 150 mg) is listed in TABLE 1 below.
TABLA 1: composición de comprimido finalTABLE 1: Final Tablet Composition
Claims (10)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES202130151U ES1286975Y (en) | 2021-01-27 | 2021-01-27 | Tablet containing 25-OH vitamin D3 |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES202130151U ES1286975Y (en) | 2021-01-27 | 2021-01-27 | Tablet containing 25-OH vitamin D3 |
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| Publication Number | Publication Date |
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| ES1286975U true ES1286975U (en) | 2022-02-22 |
| ES1286975Y ES1286975Y (en) | 2022-05-17 |
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