The present disclosure relates to an osmotic pump tablet, preparation method therefor and use thereof. The osmotic pump tablet comprises a tablet core and a coating membrane that wraps around the tablet core, with a drug-release orifice in the coating membrane. The tablet core includes a drug-containing layer, which contains an active pharmaceutical ingredient, a hydrophilic polymer, and a surfactant. The hydrophilic polymer includes hydroxypropyl cellulose, and the surfactant includes poloxamer; or the drug-containing layer contains an active pharmaceutical ingredient and a hydrophilic polymer, but no surfactant. The hydrophilic polymer includes povidone K29/32; or the osmotic pump tablet includes a drug-containing immediate release overcoat, which contains an active pharmaceutical ingredient and a pharmaceutical excipient, which is a binding agent. The osmotic pump tablet disclosed herein features high drug loading capacity, enabling it to achieve optimal therapeutic efficacy.
Provided are an osmotic pump tablet, a method for preparing same, and use thereof. The osmotic pump tablet comprises a tablet core and a coating film enclosing the tablet core. The coating film is provided with a drug release hole. The tablet core comprises a drug-containing layer. The drug-containing layer comprises an active pharmaceutical ingredient, a hydrophilic polymer, and a surfactant, the hydrophilic polymer comprises hydroxypropyl cellulose, and the surfactant comprises poloxamer. Alternatively, the drug-containing layer comprises an active pharmaceutical ingredient and a hydrophilic polymer, but does not comprise a surfactant, and the hydrophilic polymer comprises povidone K29/32. Alternatively, the osmotic pump tablet comprises a drug-containing quick-release outer coating, the drug-containing quick-release outer coating comprises an active pharmaceutical ingredient and a pharmaceutically acceptable excipient, and the pharmaceutically acceptable excipient is a binder.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
3.
METHOD FOR MEASURING CONTENT OF HYDRAZINE IN CARBIDOPA-CONTAINING DRUG
A method for measuring the content of hydrazine in a carbidopa-containing drug, comprising the following steps: (1) in a solvent, under the action of acid, mixing a sample under test with an aldehydes substance, said sample being a carbidopa-containing drug, and hydrazine in said sample and the aldehydes substance being derivatized to obtain a test solution; and (2) measuring the content of the hydrazine in the test solution. Compared with the prior art, the method for measuring the content of hydrazine in a carbidopa-containing drug does not require pretreatment to remove carbidopa, introduces negligible hydrazine during measurement, is easy to operate, does not need to accurately control derivatization time and sample introduction time, and exhibits good repeatability and accurate measurements.
PHARMACEUTICAL COMPOSITION, FORMULATION CONTAINING PHARMACEUTICAL COMPOSITION, KIT CONTAINING PHARMACEUTICAL COMPOSITION, PREPARATION METHOD FOR PHARMACEUTICAL COMPOSITION, AND USE OF PHARMACEUTICAL COMPOSITION
A pharmaceutical composition, a formulation containing the pharmaceutical composition, a kit containing the pharmaceutical composition, a preparation method for the pharmaceutical composition, and a use of the pharmaceutical composition. The pharmaceutical composition comprises the following components: an active pharmaceutical ingredient and a hot-melt adhesive, wherein the mass percentage of the active pharmaceutical ingredient is 0.3%-50%; the hot-melt adhesive is Poloxamer P188 and/or Poloxamer P407; and the mass percentage of the hot-melt adhesive in the pharmaceutical composition is 5%-30%. According to the pharmaceutical composition, the formulation containing the pharmaceutical composition, and the kit containing the pharmaceutical composition, the active pharmaceutical ingredient can be rapidly released to achieve a fast onset of action, the stability of the active pharmaceutical ingredient is improved, the swallowing of patients can be further improved, and the patient compliance during actual medicine-taking can be further improved.
Disclosed in the present invention are an oral medication dispenser, a manufacturing method therefor and a use thereof. The oral medication dispenser comprises a core assembly and a fixing device; the core assembly comprises a molar matching functional area and a medication carrying functional area which are integrally formed; the molar matching functional area comprises a first section close to the medication carrying functional area and a second section far away from the medication carrying functional area; one end of the first section is connected to one end of the second section, and the other end of the first section and the other end of the second section are open ends, so as to form a U-shaped structure; the first section and the second section match the buccal side and the lingual side of teeth, respectively; the medication carrying functional area comprises a first ring and a second ring which are coaxially arranged; the fixing device is used for enhancing the fixing effect of the core assembly on the teeth; and the fixing device is a fixator or a fixing layer. When in use, the oral medication dispenser has high wearing firmness, high safety, high comfort and a small influence on the appearance of the face.
A61M 31/00 - Dispositifs pour l'introduction ou la rétention d'agents, p. ex. de remèdes, dans les cavités du corps
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
6.
ORAL RETENTION DEVICE AND OSMOTIC PUMP TABLET, PREPARATION METHOD THEREFOR AND APPLICATION THEREOF
The present disclosure relates to an oral retention device and an osmotic pump tablet, preparation method therefor and application thereof. The medicinal tablet is inserted into the oral retention device to form a pharmaceutical device composition. The pharmaceutical device composition is fixed on the matching teeth in the oral cavity to achieve sustained release of the drug within a certain period of time. A high-dose osmotic pump tablet of the present disclosure with the absorption window of active pharmaceutical ingredients limited to the upper gastrointestinal tract has a high drug loading capacity and can achieve a good therapeutic effect.
A delayed timed release pharmaceutical composition, a preparation method therefor, and use thereof. The pharmaceutical composition comprises a tablet core. The tablet core comprises a drug-containing layer and a boosting layer stacked on the drug-containing layer. The drug-containing layer comprises a drug active ingredient. The drug active ingredient is levodopa or a derivative thereof, or a mixture of levodopa or a derivative thereof and a DOPA decarboxylase inhibitor, and accounts for 5-72.5 wt% of the content of the drug-containing layer. The pharmaceutical composition is a capsule-shaped tablet, can realize the effects of 1-3 h delayed release of the drug active ingredient and reaching a peak concentration at 6-10 h, can be used for reducing morning stiffness in patients with Parkinson's disease, and has good application prospects.
Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, an amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and a hydrophilic polymer of polyoxyethylene-polyoxypropylene glycol block copolymer. The mass percentage of the active pharmaceutical ingredient in the pharmaceutical composition is 5 wt % to 60 wt %; the mass percentage of the amphiphilic polymer in the pharmaceutical composition is 3 wt % to 40 wt %; and the mass percentage of the hydrophilic polymer in the pharmaceutical composition is 10 wt % to 90 wt %. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
A drug accommodating device of a solid oral formulation and an oral administration and delivery apparatus comprising same. The drug accommodating device comprises a filtering component and a supporting component; the filtering component and the supporting component cooperate with each other to form a space used for bearing drug particles or multiple pills; the filtering component has one or more pore channels allowing a liquid to pass; the pore channels are distributed in the filtering component in an up-down intricate intersection mode; alternatively, a water-soluble polymer material layer is provided on the filtering component. Alternatively, the drug accommodating device is a cylindrical structure with a top end being an opening and a bottom part being a screen mesh; the inner surface of the screen mesh is provided with the water-soluble polymer material layer; an inner cavity having the cylindrical structure above water-soluble polymer material layer is used for accommodating the drug particles or multiple pills. The drug accommodating device can overcome the problem that fluid resistance is large when the drug particles or multiple pills are leaked and sipped.
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
Disclosed is an oral drug delivery device, comprising a tubular member, a drug holding part, a device cap and a turbulence-creating means. The tubular member has openings at both ends and an inner cavity; the opening at one end is a first opening and the opening at the other end is a second opening; the inner cavity communicates the first opening and the second opening. The turbulence-creating means comprises a step structure or a fold structure, and is disposed in the inner cavity and positioned between the second opening and the drug holding part. By using the oral drug delivery device of the present invention, turbulence can be generated during a normal sipping process, thereby providing ample mixing of drug-containing granules or multi-particulates with drinkable liquids. Moreover, the device is telescopic, which reduces the size and is convenient to carry.
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
A61K 31/137 - Arylalkylamines, p. ex. amphétamine, épinéphrine, salbutamol, éphédrine
A61K 31/138 - Aryloxyalkylamines, p. ex. propranolol, tamoxifène, phénoxybenzamine
A61K 31/167 - Amides, p. ex. acides hydroxamiques ayant des cycles aromatiques, p. ex. colchicine, aténolol, progabide ayant l'atome d'azote d'un groupe carboxamide lié directement au cycle aromatique, p. ex. lidocaïne, paracétamol
A61K 31/197 - Acides carboxyliques, p. ex. acide valproïque ayant un groupe amino les groupes amino et carboxyle étant liés à la même chaîne carbone acyclique, p. ex. acide gamma-aminobutyrique [GABA], bêta-alanine, acide epsilon-aminocaproïque ou acide pantothénique
A61K 31/43 - Composés contenant des systèmes cycliques thia-4 aza-1 bicyclo [3.2.0] heptane, c.-à-d. composés contenant un système cyclique de formule , p. ex. pénicillines, pénèmes
A61K 31/4402 - Pyridines non condenséesLeurs dérivés hydrogénés substituées uniquement en position 2, p. ex. phéniramine, bisacodyl
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
A61K 31/4748 - QuinoléinesIsoquinoléines formant une partie de systèmes cycliques pontés
A61K 31/7048 - Composés ayant des radicaux saccharide et des hétérocycles ayant l'oxygène comme hétéro-atome d'un cycle, p. ex. leucoglucosane, hespéridine, érythromycine, nystatine
11.
ORAL RETENTION DEVICE AND PREPARATION METHOD THEREFOR
Disclosed are an oral retention device and a preparation method therefor. The oral retention device comprises a tooth fitting component and a drug loading component. The tooth fitting component is connected to the drug loading component. The tooth fitting component is used for bridging a tooth in the oral cavity and matching same and the tooth. The drug loading component can accommodate at least one tablet, and is used for making the tablet retained in the oral cavity. The preparation method for the oral retention device is selected from any one of 3D printing, injection molding, or stamp molding. When the tablet is inserted into the oral retention device of the present invention, a drug-device combination product can be formed, the drug-device combination product is fixed onto the fitting teeth in the oral cavity, and the tablet is not easy to fall off in the oral cavity, so that the medicine can be continuously released within a certain time, the tablet can be replaced, and the medicine is continuously and stably released.
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
12.
Pharmaceutical composition containing dabigatran etexilate and preparation method thereof
Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and a amphiphilic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23 to 1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
A61K 47/10 - AlcoolsPhénolsLeurs sels, p. ex. glycérolPolyéthylène glycols [PEG]PoloxamèresAlkyléthers de PEG/POE
A61K 47/12 - Acides carboxyliquesLeurs sels ou anhydrides
A61K 47/26 - Hydrates de carbone, p. ex. polyols ou sucres alcoolisés, sucres aminés, acides nucléiques, mono-, di- ou oligosaccharidesLeurs dérivés, p. ex. polysorbates, esters d’acide gras de sorbitan ou glycyrrhizine
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
Disclosed are a controlled-release dosage form with an absorption window in the upper gastrointestinal tract and a preparation method therefor, wherein the controlled-release dosage form comprises a controlled-release platform and a retention platform. The controlled-release platform is a pharmaceutical composition comprising a tablet core and a coating membrane; and the retention platform holds the controlled-release platform in the oral cavity. The operation steps of the controlled-release dosage form are as follows: placing the controlled-release platform in the retention platform, and fixing the retention platform on matching teeth in the oral cavity; taking out the controlled-release dosage form after 4-24 hours and replacing same with a new controlled-release platform; and re-fixing the retention platform on the matching teeth in the oral cavity to achieve the sustained and stable release of drugs.
A drug accommodating device of a solid oral formulation, and an oral administration and delivery apparatus comprising same. The drug accommodating device comprises a filtering component and a supporting component; the filtering component and the supporting component cooperate with each other to form a space used for bearing drug particles or multiple pills; the filtering component has one or more pore channels allowing a liquid to pass; the pore channels are distributed in the filtering component in an up-down intricate intersection mode; alternatively, a water-soluble polymer material layer is provided on the filtering component. Alternatively, the drug accommodating device is a cylindrical structure with a top end being an opening and a bottom part being a screen mesh; the inner surface of the screen mesh is provided with the water-soluble polymer material layer; an inner cavity having the cylindrical structure above water-soluble polymer material layer is used for accommodating the drug particles or multiple pills. The drug accommodating device can overcome the problem that fluid resistance is large when the drug particles or multiple pills are leaked and sipped.
A61J 1/03 - Récipients spécialement adaptés à des fins médicales ou pharmaceutiques pour pilules ou comprimés
A61J 1/00 - Récipients spécialement adaptés à des fins médicales ou pharmaceutiques
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
15.
Pharmaceutical composition and preparation method therefor and use thereof
Disclosed are a pharmaceutical composition, an osmotic pump controlled-release drug delivery system comprising the pharmaceutical composition and a preparation method therefor. The pharmaceutical composition comprises a tablet core and a coating film. The tablet core comprises a drug-pulling layer, and the coating film comprises 50-90 wt % of cellulose acetate and 10-50 wt % of Copovidone. The Copovidone can be obtained by means of the polymerization of vinyl pyrrolidone and vinyl acetate in a molar ratio of 40:60-80:20.
A61K 31/197 - Acides carboxyliques, p. ex. acide valproïque ayant un groupe amino les groupes amino et carboxyle étant liés à la même chaîne carbone acyclique, p. ex. acide gamma-aminobutyrique [GABA], bêta-alanine, acide epsilon-aminocaproïque ou acide pantothénique
A61K 31/198 - Alpha-amino-acides, p. ex. alanine ou acide édétique [EDTA]
A61K 31/522 - Purines, p. ex. adénine ayant des groupes oxo liés directement à l'hétérocycle, p. ex. hypoxanthine, guanine, acyclovir
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
A solid particle, a preparation method therefor, and a pharmaceutical composition. The solid particle comprises a porous solid particle and a non-aqueous liquid formula. The non-aqueous liquid formula comprises 0.10-4.00 wt % of a hydrophobic active pharmaceutical agent, 28.00-99.90 wt % of a hydrophobic solubilizing solution, 0-70.00 wt % of a non-ionic surfactant, and 0-1.00 wt % of an antioxidant. The hydrophobic solubilizing solution comprises a medium-chain monoglyceride and diglyceride, and/or a propylene glycol fatty acid monoester.
Disclosed is an oral drug delivery device, comprising a tubular member, a drug accommodating part, a device cap and a turbulence generating part. The tubular member has openings at both ends and an inner cavity; the opening at one end is a first opening and the opening at the other end is a second opening; the inner cavity communicates the first opening and the second opening. The turbulence generating part comprises a step structure or a fold structure, and is disposed in the inner cavity and positioned between the second opening and the drug accommodating part. The drug accommodating part and the device cap have structures and connection relationship with the tubular member as described in the present invention. By using the oral drug delivery device of the present invention, turbulence can be generated during a normal sipping process, thereby providing ample mixing of drug-containing particles or multi-pills with drinkable liquids. Moreover, the device is telescopic, which reduces the size and is convenient to carry.
A61J 7/00 - Dispositifs pour administrer les médicaments par voie buccale, p. ex. cuillèresDispositifs pour compter les pilulesDispositions pour l'indication ou le rappel du moment où l'on doit prendre des médicaments
A61F 2/00 - Filtres implantables dans les vaisseaux sanguinsProthèses, c.-à-d. éléments de substitution ou de remplacement pour des parties du corpsAppareils pour les assujettir au corpsDispositifs maintenant le passage ou évitant l'affaissement de structures corporelles tubulaires, p. ex. stents
18.
CONTROLLED-RELEASE SYSTEM OF ACTIVE PHARMACEUTICAL INGREDIENT AND PREPARATION METHOD THEREFOR
Disclosed are a controlled-release dosage form with an absorption window in the upper gastrointestinal tract and a preparation method therefor, wherein the controlled-release dosage form comprises a controlled-release platform and a retention platform. The controlled-release platform is a pharmaceutical composition comprising a tablet core and a coating film; and the retention platform holds the controlled-release platform in the oral cavity. The operation steps of the controlled-release dosage form are as follows: placing the controlled-release platform in the retention platform, and fixing the retention platform on matching teeth in the oral cavity; taking out the controlled-release dosage form after 4-24 hours and replacing same with a new controlled-release platform; and re-fixing the retention platform on the matching teeth in the oral cavity to achieve the sustained and stable release of drugs.
Disclosed is a pharmaceutical composition containing dabigatran etexilate and a preparation method thereof. The pharmaceutical composition comprises a pharmaceutically active ingredient, dabigatran etexilate and/or dabigatran etexilate mesylate, and a zwitterionic polymer of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer. The mass ratio of the two is 1:0.23-1:3. The pharmaceutical composition not only increases the bioavailability of the pharmaceutically active ingredient, but also reduces absorption variability, and provides a more stable concentration of dabigatran in plasma, thereby reducing adverse side effects.
A61K 47/34 - Composés macromoléculaires obtenus par des réactions autres que celles faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. polyesters, acides polyaminés, polysiloxanes, polyphosphazines, copolymères de polyalkylène glycol ou de poloxamères
A61K 31/4439 - Pyridines non condenséesLeurs dérivés hydrogénés contenant d'autres systèmes hétérocycliques contenant un cycle à cinq chaînons avec l'azote comme hétéro-atome du cycle, p. ex. oméprazole
Disclosed are a pharmaceutical composition, an osmotic pump controlled-release drug delivery system comprising the pharmaceutical composition and a preparation method therefor. The pharmaceutical composition comprises a tablet core and a coating film. The tablet core comprises a drug-pulling layer, and the coating film comprises 50-90 wt% of cellulose acetate and 10-50 wt% of copovidone. The copovidone can be obtained by means of the polymerization of vinyl pyrrolidone and vinyl acetate in a molar ratio of 40: 60-80: 20.
A61K 47/32 - Composés macromoléculaires obtenus par des réactions faisant intervenir uniquement des liaisons non saturées carbone-carbone, p. ex. carbomères
A solid particle, a preparation method therefor, and a pharmaceutical composition. The solid particle comprises a porous solid particle and a non-aqueous liquid formula. The non-aqueous liquid formula comprises 0.10-4.00 wt% of a hydrophobic active pharmaceutical agent, 28.00-99.90 wt% of a hydrophobic solubilizing solution, 0-70.00 wt% of a non-ionic surfactant, and 0-1.00 wt% of an antioxidant. The hydrophobic solubilizing solution comprises a medium-chain monoglyceride and diglyceride, and/or a propylene glycol fatty acid monoester.
A61K 9/48 - Préparations en capsules, p. ex. de gélatine, de chocolat
A61K 31/58 - Composés contenant des systèmes cycliques du cyclopenta[a]hydrophénanthrèneLeurs dérivés, p. ex. stéroïdes contenant des hétérocycles, p. ex. danazol, stanozolol, pancuronium ou digitogénine
A61K 31/145 - Amines, p. ex. amantadine ayant des atomes de soufre, p. ex. thiurames (N-C(S)-S-C(S)-N ou N-C(S)-S-S-C(S)-N)Sulfinylamines (-N=SO)Sulfonylamines (-N=SO2)
A61K 47/44 - Huiles, graisses ou cires couvertes par plus d’un des groupes Huiles, graisses ou cires naturelles ou naturelles modifiées, p. ex. huile de ricin, huile de ricin polyéthoxylée, cire de lignite, lignite, gomme-laque, colophane, cire d’abeille ou lanoline
brevets
