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1. WO2009050738 - AN ORALLY ADMINISTERABLE SOLID PHARMACEUTICAL COMPOSITION AND A PROCESS THEREOF

N.º de publicación WO/2009/050738
Fecha de publicación 23.04.2009
Nº de la solicitud internacional PCT/IN2008/000683
Fecha de presentación internacional 16.10.2008
Se presentó la solicitud en virtud del Capítulo II 24.06.2009
CIP
A61K 38/28 2006.1
ANECESIDADES CORRIENTES DE LA VIDA
61CIENCIAS MEDICAS O VETERINARIAS; HIGIENE
KPREPARACIONES DE USO MEDICO, DENTAL O PARA EL ASEO
38Preparaciones medicinales que contienen péptidos
16Péptidos que tienen más de 20 aminoácidos; Gastrinas; Somatostatinas; Melanotropinas; Sus derivados
17que provienen de animales; que provienen de humanos
22Hormonas
28Insulinas
A61K 47/14 2006.1
ANECESIDADES CORRIENTES DE LA VIDA
61CIENCIAS MEDICAS O VETERINARIAS; HIGIENE
KPREPARACIONES DE USO MEDICO, DENTAL O PARA EL ASEO
47Preparaciones medicinales caracterizadas por los ingredientes no activos utilizados, p. ej. portadores o aditivos inertes; Agentes de direccionamiento o agentes modificadores enlazados químicamente al ingrediente activo
06Compuestos orgánicos, p. ej. hidrocarburos naturales o sintéticos, poliolefinas, aceite mineral, petrolato u ozoquerita
08que contienen oxígeno
14Esteres de ácidos carboxílicos, p. ej. monoglicéridos de ácidos grasos, triglicéridos de cadenas medianas, parabenos o ésteres de ácidos grasos y de polietilenglicol (PEG)
A61K 47/12 2006.1
ANECESIDADES CORRIENTES DE LA VIDA
61CIENCIAS MEDICAS O VETERINARIAS; HIGIENE
KPREPARACIONES DE USO MEDICO, DENTAL O PARA EL ASEO
47Preparaciones medicinales caracterizadas por los ingredientes no activos utilizados, p. ej. portadores o aditivos inertes; Agentes de direccionamiento o agentes modificadores enlazados químicamente al ingrediente activo
06Compuestos orgánicos, p. ej. hidrocarburos naturales o sintéticos, poliolefinas, aceite mineral, petrolato u ozoquerita
08que contienen oxígeno
12Acidos carboxílicos; Sus sales o anhídridos
A61K 47/48 2006.1
ANECESIDADES CORRIENTES DE LA VIDA
61CIENCIAS MEDICAS O VETERINARIAS; HIGIENE
KPREPARACIONES DE USO MEDICO, DENTAL O PARA EL ASEO
47Preparaciones medicinales caracterizadas por los ingredientes no activos utilizados, p. ej. portadores o aditivos inertes; Agentes de direccionamiento o agentes modificadores enlazados químicamente al ingrediente activo
48estando el ingrediente no activo químicamente unido al ingrediente activo, p. ej. conjugados polímero-medicamento
CPC
A61K 38/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
28Insulins
A61K 47/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/50
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
A61K 47/542
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
54the modifying agent being an organic compound
542Carboxylic acids, e.g. a fatty acid or an amino acid
A61K 47/543
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
54the modifying agent being an organic compound
543Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
A61K 9/1617
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1617Organic compounds, e.g. phospholipids, fats
Solicitantes
  • BIOCON LIMITED [IN]/[IN] (AllExceptUS)
  • KHEDKAR, Anand [IN]/[IN] (UsOnly)
  • RANGAPPA, Sharath, Kumar, Mallapura [IN]/[IN] (UsOnly)
  • SUBRAMANI, Ramesh [IN]/[IN] (UsOnly)
  • DAVE, Nitesh [IN]/[IN] (UsOnly)
  • RADHAKRISHNAN, Devesh [IN]/[IN] (UsOnly)
  • SHANKAR, Sundaresh [IN]/[IN] (UsOnly)
  • CHIVUKULA, Sudheer [IN]/[IN] (UsOnly)
  • RAMAKRISHNA, Ranjith [IN]/[IN] (UsOnly)
  • MURTHY, Shanmugam, Thandava [IN]/[IN] (UsOnly)
  • PAI, Harish Venkatraman [IN]/[IN] (UsOnly)
  • SENGUPTA, Nilanjan [IN]/[IN] (UsOnly)
  • MELARKODE, Ramakrishnan [IN]/[IN] (UsOnly)
  • IYER, Harish [IN]/[IN] (UsOnly)
Inventores
  • KHEDKAR, Anand
  • RANGAPPA, Sharath, Kumar, Mallapura
  • SUBRAMANI, Ramesh
  • DAVE, Nitesh
  • RADHAKRISHNAN, Devesh
  • SHANKAR, Sundaresh
  • CHIVUKULA, Sudheer
  • RAMAKRISHNA, Ranjith
  • MURTHY, Shanmugam, Thandava
  • PAI, Harish Venkatraman
  • SENGUPTA, Nilanjan
  • MELARKODE, Ramakrishnan
  • IYER, Harish
Mandatarios
  • MARAM, Suresh, Gupta
Datos de prioridad
00714/CHE/200824.03.2008IN
02340/CHE/200716.10.2007IN
Idioma de publicación Inglés (en)
Idioma de solicitud Inglés (EN)
Estados designados
Título
(EN) AN ORALLY ADMINISTERABLE SOLID PHARMACEUTICAL COMPOSITION AND A PROCESS THEREOF
(FR) COMPOSITION PHARMACEUTIQUE SOLIDE ADMINISTRABLE PAR VOIE ORALE ET PROCÉDÉ ASSOCIÉ
Resumen
(EN) The invention relates to improvised pharmaceutical compositions permitting ingestion via oral delivery of proteins/peptides or their conjugates, and/or cation-insulin conjugate complexes demonstrating desirable pharmacokinetic profiles and potency in efficacy models of diabetes in dogs and humans. A preferred formulation comprises 0.01% - 20% w/w of insulin, insulin compound conjugates and/or cation insulin conjugates, 10% - 60% w/w of one or more fatty acid components selected from saturated or unsaturated C4-C12 fatty acids and/or salts of such fatty acids and additionally contains optimal amounts of other pharmaceutically suitable polymer excipients which permit improved solubility, dissolution rate and effective bioavailability of poorly water soluble compositions and consistent in-vivo release profiles upon scalability during manufacture. A further aspect of the invention features the process of preparing the aforesaid formulations.
(FR) La présente invention concerne des compositions pharmaceutiques améliorées permettant l'ingestion par voie orale de protéines/peptides ou de leurs conjugués, et/ou de complexes conjugués cation-insuline présentant une efficacité et un profil pharmacocinétique intéressants dans des modèles d'efficacité de diabète chez le chien et l'être humain. Une composition préférée comprend de 0,01 à 20 % poids/poids d'insuline, de conjugués d'un composé d'insuline et/ou de conjugués cation-insuline, de 10 à 60 % poids/poids d'au moins un composant de type acide gras choisi parmi les acides gras en C4-C12 saturés ou insaturés et/ou parmi les sels desdits acides gras et, en outre, des quantités optimales d'autres excipients polymériques acceptables d'un point de vue pharmaceutique et permettant l'amélioration de la solubilité, du taux de dissolution et de la biodisponibilité effective de compositions faiblement solubles dans l'eau, ainsi que l'obtention de profils de libération in vivo cohérents en cas de mise en œuvre de quantités plus importantes lors de la fabrication. Un aspect supplémentaire de l'invention concerne le procédé de préparation des compositions susmentionnées.
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