IT201800020185A1 - FORMULATIONS CONTAINING VITAMIN D3 IN EDIBLE FILM FOR THE TREATMENT OF PATIENTS WITH MALABSORPTION - Google Patents
FORMULATIONS CONTAINING VITAMIN D3 IN EDIBLE FILM FOR THE TREATMENT OF PATIENTS WITH MALABSORPTION Download PDFInfo
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- IT201800020185A1 IT201800020185A1 IT102018000020185A IT201800020185A IT201800020185A1 IT 201800020185 A1 IT201800020185 A1 IT 201800020185A1 IT 102018000020185 A IT102018000020185 A IT 102018000020185A IT 201800020185 A IT201800020185 A IT 201800020185A IT 201800020185 A1 IT201800020185 A1 IT 201800020185A1
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- vitamin
- patients
- treatment
- malabsorption
- edible film
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- 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 title claims description 20
- 239000000203 mixture Substances 0.000 title claims description 11
- 206010025476 Malabsorption Diseases 0.000 title description 5
- 208000004155 Malabsorption Syndromes Diseases 0.000 title description 4
- 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 claims description 18
- 235000005282 vitamin D3 Nutrition 0.000 claims description 18
- 239000011647 vitamin D3 Substances 0.000 claims description 18
- 229940021056 vitamin d3 Drugs 0.000 claims description 18
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 10
- 238000009472 formulation Methods 0.000 claims description 9
- 201000003883 Cystic fibrosis Diseases 0.000 claims description 8
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 7
- 229940088594 vitamin Drugs 0.000 claims description 6
- 229930003231 vitamin Natural products 0.000 claims description 6
- 235000013343 vitamin Nutrition 0.000 claims description 6
- 239000011782 vitamin Substances 0.000 claims description 6
- 235000019168 vitamin K Nutrition 0.000 claims description 6
- 239000011712 vitamin K Substances 0.000 claims description 6
- 229930003448 Vitamin K Natural products 0.000 claims description 5
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 claims description 5
- 150000003721 vitamin K derivatives Chemical class 0.000 claims description 5
- 229940046010 vitamin k Drugs 0.000 claims description 5
- 235000019155 vitamin A Nutrition 0.000 claims description 4
- 239000011719 vitamin A Substances 0.000 claims description 4
- 235000019165 vitamin E Nutrition 0.000 claims description 4
- 239000011709 vitamin E Substances 0.000 claims description 4
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims description 3
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 3
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 claims description 3
- 229930003268 Vitamin C Natural products 0.000 claims description 3
- 229930003427 Vitamin E Natural products 0.000 claims description 3
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims description 3
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 3
- 230000003232 mucoadhesive effect Effects 0.000 claims description 3
- 235000019154 vitamin C Nutrition 0.000 claims description 3
- 239000011718 vitamin C Substances 0.000 claims description 3
- 229940046009 vitamin E Drugs 0.000 claims description 3
- 229940045997 vitamin a Drugs 0.000 claims description 3
- 208000000412 Avitaminosis Diseases 0.000 claims description 2
- 206010047627 Vitamin deficiencies Diseases 0.000 claims description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 5
- 238000010521 absorption reaction Methods 0.000 description 3
- 230000007812 deficiency Effects 0.000 description 3
- 210000000496 pancreas Anatomy 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 102000012605 Cystic Fibrosis Transmembrane Conductance Regulator Human genes 0.000 description 2
- 108010079245 Cystic Fibrosis Transmembrane Conductance Regulator Proteins 0.000 description 2
- 102000004127 Cytokines Human genes 0.000 description 2
- 108090000695 Cytokines Proteins 0.000 description 2
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- MECHNRXZTMCUDQ-UHFFFAOYSA-N Vitamin D2 Natural products C1CCC2(C)C(C(C)C=CC(C)C(C)C)CCC2C1=CC=C1CC(O)CCC1=C MECHNRXZTMCUDQ-UHFFFAOYSA-N 0.000 description 2
- 235000010323 ascorbic acid Nutrition 0.000 description 2
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- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 2
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
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- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
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- 208000001132 Osteoporosis Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 206010041969 Steatorrhoea Diseases 0.000 description 1
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- POIUWJQBRNEFGX-XAMSXPGMSA-N cathelicidin Chemical compound C([C@@H](C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CO)C(O)=O)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@H](CC(C)C)NC(=O)[C@@H](N)CC(C)C)C1=CC=CC=C1 POIUWJQBRNEFGX-XAMSXPGMSA-N 0.000 description 1
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Classifications
-
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
Description
Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:
FORMULAZIONI CONTENENTI VITAMINA D3 IN FILM EDIBILE PER IL TRATTAMENTO DI PAZIENTI AFFETTI DA MALASSORBIMENTO FORMULATIONS CONTAINING VITAMIN D3 IN EDIBLE FILM FOR THE TREATMENT OF PATIENTS WITH MALABSORPTION
RIASSUNTO DELL’INVENZIONE SUMMARY OF THE INVENTION
La presente invenzione ha per oggetto formulazioni in forma di film edibili contenente Vitamina D3 per il trattamento di situazioni carenziali legate al malassorbimento di Vitamina D3, specialmente in condizioni di ridotta funzionalità pancreatica come ad esempio in pazienti affetti da fibrosi cistica. The present invention relates to formulations in the form of edible films containing Vitamin D3 for the treatment of deficiency situations linked to the malabsorption of Vitamin D3, especially in conditions of reduced pancreatic function such as in patients suffering from cystic fibrosis.
STATO DELLA TECNICA STATE OF THE TECHNIQUE
Le Vitamine del gruppo D hanno un ruolo essenziale nel favorire l’assorbimento del calcio a livello osseo. Una loro carenza è un fattore che contribuisce all’insorgenza di malattie ossee, come l’osteoporosi o il rachitismo. Vitamins of group D play an essential role in promoting the absorption of calcium in the bone. Their deficiency is a factor that contributes to the onset of bone diseases, such as osteoporosis or rickets.
La Vitamina D2 o ergocalciferolo si trova negli alimenti di origine vegetale mentre la vitamina D3 o colicalciferolo è presente nei prodotti di origine animale, in particolare generalmente nei grassi. Sono ricchi di vitamina D3 l’olio di fegato di merluzzo, il burro e il fegato di animali da allevamento. Vitamin D2 or ergocalciferol is found in foods of plant origin while vitamin D3 or colicalciferol is present in products of animal origin, particularly generally in fats. Cod liver oil, butter and the liver of farm animals are rich in vitamin D3.
Oltre alle proprietà note sul metabolismo del calcio e del fosforo, le Vitamine D esercitano una importante azione immunoregolatrice. In particolare la Vitamina D3 modula la proliferazione dei linfociti T e la produzione di citochine, diminuendo le Th1 e inibendo lo sviluppo delle Th17. Vi è inoltre una stretta correlazione tra livelli di Vitamina D3 e funzione polmonare. Alti livelli di Vitamina D3 sono associati ad una migliore funzione polmonare e a una più bassa incidenza di esacerbazioni infettive. In addition to the known properties on the metabolism of calcium and phosphorus, Vitamins D exert an important immunoregulatory action. In particular, Vitamin D3 modulates the proliferation of T lymphocytes and the production of cytokines, decreasing Th1 and inhibiting the development of Th17. There is also a close correlation between Vitamin D3 levels and lung function. High levels of Vitamin D3 are associated with better lung function and a lower incidence of infectious exacerbations.
L’effetto della Vitamina D3 nel proteggere la funzione respiratoria sembra anche legato ad un’azione inibitoria sui livelli di citochine pro-infiammatorie e alla capacità di inibire lo stress ossidativo e l’omeostasi di proteasi-antiproteasi, con riduzione della degradazione del collagene e del rimodellamento polmonare. The effect of Vitamin D3 in protecting respiratory function also appears to be linked to an inhibitory action on the levels of pro-inflammatory cytokines and to the ability to inhibit oxidative stress and protease-antiprotease homeostasis, with a reduction in the degradation of collagen and lung remodeling.
La Vitamina D3 protegge il sistema respiratorio da infezioni anche grazie alla capacità di indurre l’espressione genica di peptidi antimicrobici quali catelicidina e beta defensine. Bassi livelli di Vitamina D3 sono stati infatti identificati in pazienti affetti da tubercolosi. Vitamin D3 protects the respiratory system from infections also thanks to its ability to induce gene expression of antimicrobial peptides such as cathelicidin and beta defensins. Low levels of Vitamin D3 have in fact been identified in patients with tuberculosis.
Le Vitamine del gruppo D risultano carenti in larghe fasce della popolazione ma in particolare nei pazienti caratterizzati da malassorbimento principalmente per insufficienza pancreatica come ad esempio i pazienti affetti da Fibrosi Cistica (FC), una malattia genetica autosomica recessiva diffusa nella popolazione caucasica, con un’incidenza di circa 1/4.000 nati vivi. Vitamins of group D are deficient in large sections of the population but in particular in patients characterized by malabsorption mainly due to pancreatic insufficiency such as patients with Cystic Fibrosis (CF), an autosomal recessive genetic disease widespread in the Caucasian population, with a incidence of about 1 / 4,000 live births.
La FC è causata da una mutazione del gene CFTCR (Cystic Fibrosis Transmembrane Conductance Regulator), presente sul cromosoma 7, che codifica una proteina di 1480 aminoacidi, situata sulla membrana cellulare delle cellule epiteliali, la cui funzione è quella di trasportare il cloro attraverso le membrane cellulari a livello della membrana apicale delle cellule epiteliali delle vie aeree, del pancreas, dell’intestino, delle ghiandole sudoripare, delle ghiandole salivari e dei vasi deferenti. CF is caused by a mutation in the CFTCR (Cystic Fibrosis Transmembrane Conductance Regulator) gene, present on chromosome 7, which encodes a protein of 1480 amino acids, located on the cell membrane of epithelial cells, whose function is to transport chlorine through the cell membranes at the level of the apical membrane of epithelial cells of the airways, pancreas, intestine, sweat glands, salivary glands and vas deferens.
Negli organi interessati, le secrezioni mucose, essendo anormalmente viscose e poco scorrevoli, determinano un’ostruzione dei dotti principali, provocando l’insorgenza di gran parte delle manifestazioni cliniche tipiche della malattia, come la comparsa di infezioni polmonari ricorrenti, insufficienza pancreatica, steatorrea, stati di malnutrizione, cirrosi epatica, ostruzione intestinale e infertilità maschile. In the affected organs, mucous secretions, being abnormally viscous and poorly flowing, cause obstruction of the main ducts, causing the onset of most of the typical clinical manifestations of the disease, such as the appearance of recurrent lung infections, pancreatic insufficiency, steatorrhea, states of malnutrition, liver cirrhosis, intestinal obstruction and male infertility.
Il pancreas è colpito nell’80% dei casi con un ristagno dei succhi pancreatici nei dotti e formazione di cisti. Il pancreas di un paziente affetto da fibrosi cistica è di conseguenza meno funzionalmente capace di secernere un succo pancreatico in grado di facilitare la digestione dei grassi e di conseguenza, in questi pazienti, l’assorbimento e la metabolizzazione enzimatica dei lipidi risulta molto compromessa con conseguenti gravi condizionamenti dietetici. Tra i lipidi scarsamente assorbiti di particolare rilevanza sono le vitamine liposolubili A, D, E e K (ADEK). Per questa ragione il malato FC è carente di vitamine liposolubili ed in particolare di Vitamine del gruppo D. The pancreas is affected in 80% of cases with a stagnation of pancreatic juices in the ducts and the formation of cysts. The pancreas of a patient with cystic fibrosis is consequently less functionally capable of secreting a pancreatic juice capable of facilitating the digestion of fats and consequently, in these patients, the absorption and enzymatic metabolization of lipids is very compromised with consequent severe dietary conditioning. Among the poorly absorbed lipids of particular relevance are the fat-soluble vitamins A, D, E and K (ADEK). For this reason, the CF patient is deficient in fat-soluble vitamins and in particular in Vitamins of group D.
DESCRIZIONE DELL’INVENZIONE DESCRIPTION OF THE INVENTION
L’invenzione riguarda composizioni dietetiche o farmaceutiche comprendenti vitamina D3 ed eventualmente altre vitamine liposolubili in forma di film edibile mucoadesivo, per uso nel trattamento di carenze vitaminiche in pazienti affetti da fibrosi cistica. The invention relates to dietary or pharmaceutical compositions including vitamin D3 and possibly other fat-soluble vitamins in the form of an edible mucoadhesive film, for use in the treatment of vitamin deficiencies in patients suffering from cystic fibrosis.
La forma di film edibile mucoadesivo è in grado di sciogliersi in bocca in meno di un minuto e di facilitare l’assorbimento trans-mucosale della Vitamina D3. The mucoadhesive edible film form is able to dissolve in the mouth in less than a minute and facilitate the trans-mucosal absorption of Vitamin D3.
Le formulazioni dell’invenzione permettono di ridurre lo stato carenziale nei pazienti con malassorbimento intestinale. La somministrazione trans-mucosale consente di ridurre la quota che deve essere assorbita per via gastrointestinale. Viene ridotta di conseguenza l’importanza del deficit pancreatico. The formulations of the invention allow to reduce the deficiency status in patients with intestinal malabsorption. Transmucosal administration allows to reduce the amount that must be absorbed via the gastrointestinal route. Consequently, the importance of the pancreatic deficit is reduced.
Il film edibile è inoltre in grado di facilitare la somministrazione della Vitamina D3 a pazienti che presentano difficoltà di deglutizione, quali bambini ed anziani. Il film edibile inoltre non necessita di acqua per essere assunto, è facilmente aromatizzabile e di conseguenza risulta di facile e piacevole assunzione. Trattandosi inoltre di un trattamento che deve essere effettuato cronicamente, la facilità e la gradevolezza della assunzione risultano ulteriormente vantaggiosi. The edible film is also able to facilitate the administration of Vitamin D3 to patients with swallowing difficulties, such as children and the elderly. Furthermore, the edible film does not require water to be taken, it is easily flavored and consequently it is easy and pleasant to take. Furthermore, since it is a treatment that must be carried out chronically, the ease and pleasantness of the intake are further advantageous.
Le formulazioni dell’invenzione comprendono tra 1000 e 10.000 UI di Vitamina D3 ed eventualmente una o più di Vitamina A, Vitamina E, Vitamina K e Vitamina C, in dosaggi compresi tra 5.000 e 10.000 UI di Vitamina A, tra 100 e 200 UI di Vitamina E e da 0,3 a 0,5 mg di Vitamina K. The formulations of the invention comprise between 1000 and 10,000 IU of Vitamin D3 and possibly one or more of Vitamin A, Vitamin E, Vitamin K and Vitamin C, in dosages between 5,000 and 10,000 IU of Vitamin A, between 100 and 200 IU of Vitamin E and 0.3 to 0.5 mg of Vitamin K.
La Vitamina C può essere presente in dosi da 60 a 100 mg. E’ preferita una formulazione comprendente Vitamina D3 e Vitamina K. Vitamin C can be present in doses from 60 to 100 mg. A formulation comprising Vitamin D3 and Vitamin K is preferred.
Il film edibile è preparato a partire da polimeri idrosolubili mucoadesivi scelti fra cellulosa, derivati di cellulosa (idrossipropilcellulosa, idrossietilcellulosa, carbossimetilcellulosa), polivinilacetato/polivinilalcol, polietilenglicol, gomme naturali quali gomma guar, gomma xantana, gomma arabica. La percentuale sul peso totale del film di detti polimeri è compresa tra il 50 ed il 75%. The edible film is prepared starting from water-soluble mucoadhesive polymers selected from cellulose, cellulose derivatives (hydroxypropylcellulose, hydroxyethylcellulose, carboxymethylcellulose), polyvinyl acetate / polyvinyl alcohol, polyethylene glycol, natural gums such as guar gum, xanthan gum, arabic gum. The percentage of the total weight of the film of said polymers is between 50 and 75%.
Ai polimeri mucoadesivi possono essere aggiunti uno o più dei seguenti componenti: alginati, maltodestrine, glicerina, mono e digliceridi, tensioattivi, preferibilmente tensioattivi non ionici, mannitolo, polivinilpirrolidone, plasticizzanti a base di polioli, sucralosio, antiossidanti quali acido ascorbico, tocoferolo, acqua ed eventualmente coloranti ed aromatizzanti. One or more of the following components can be added to the mucoadhesive polymers: alginates, maltodextrins, glycerin, mono and diglycerides, surfactants, preferably non-ionic surfactants, mannitol, polyvinylpyrrolidone, polyol-based plasticizers, sucralose, antioxidants such as ascorbic acid, tocopherol, water and possibly dyes and flavorings.
Si riporta di seguito un esempio di formulazione dell’invenzione. Below is an example of the formulation of the invention.
ESEMPIO 1 EXAMPLE 1
Vitamina D3: 100 mcg Vitamin D3: 100 mcg
Sodio alginato: 0,5-5% Sodium alginate: 0.5-5%
Glicerolo: 10% -20% Glycerol: 10% -20%
Acqua: 20% Water: 20%
Acido ascorbico: 1-5% Ascorbic acid: 1-5%
polivinilacetato/polivinilalcol: 50-75%. polyvinyl acetate / polyvinyl alcohol: 50-75%.
Claims (4)
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| Application Number | Priority Date | Filing Date | Title |
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| IT102018000020185A IT201800020185A1 (en) | 2018-12-19 | 2018-12-19 | FORMULATIONS CONTAINING VITAMIN D3 IN EDIBLE FILM FOR THE TREATMENT OF PATIENTS WITH MALABSORPTION |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102018000020185A IT201800020185A1 (en) | 2018-12-19 | 2018-12-19 | FORMULATIONS CONTAINING VITAMIN D3 IN EDIBLE FILM FOR THE TREATMENT OF PATIENTS WITH MALABSORPTION |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030224044A1 (en) * | 2002-02-13 | 2003-12-04 | Weibel Michael K. | Drug dose-form and method of manufacture |
| US20150038594A1 (en) * | 2013-07-31 | 2015-02-05 | Bluepharma | Oral dispersible films |
| US9439913B1 (en) * | 2013-11-15 | 2016-09-13 | MVW Nutritionals, Inc. | Fat-soluble vitamin formulations |
| CN105982072A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Vitamin D3 calcium carbonate oral cavity instant films and preparation method thereof |
| WO2017147420A1 (en) * | 2016-02-25 | 2017-08-31 | The University Of Florida Research Foundation, Inc. | Methods and compositions with vitamin d compounds for treatment of cystic fibrosis and respiratory disorders |
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2018
- 2018-12-19 IT IT102018000020185A patent/IT201800020185A1/en unknown
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030224044A1 (en) * | 2002-02-13 | 2003-12-04 | Weibel Michael K. | Drug dose-form and method of manufacture |
| US20150038594A1 (en) * | 2013-07-31 | 2015-02-05 | Bluepharma | Oral dispersible films |
| US9439913B1 (en) * | 2013-11-15 | 2016-09-13 | MVW Nutritionals, Inc. | Fat-soluble vitamin formulations |
| CN105982072A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Vitamin D3 calcium carbonate oral cavity instant films and preparation method thereof |
| WO2017147420A1 (en) * | 2016-02-25 | 2017-08-31 | The University Of Florida Research Foundation, Inc. | Methods and compositions with vitamin d compounds for treatment of cystic fibrosis and respiratory disorders |
Non-Patent Citations (1)
| Title |
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| CHESDACHAI SUPAVIT ET AL: "Treatment of vitamin D deficiency in cystic fibrosis", JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY, ELSEVIER SCIENCE LTD., OXFORD, GB, vol. 164, 10 September 2015 (2015-09-10), pages 36 - 39, XP029797775, ISSN: 0960-0760, DOI: 10.1016/J.JSBMB.2015.09.013 * |
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