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Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1

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US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG . 1A *Release FIG . 1B Postabsorption . Plasmadruglevel groupon.www Blimination hoolimason Absorption cocinio concentration , Coax Time FIG . 1C Patent Application Publication Jun . 27 , 2019 Sheet 2 of 20 US 2019 /0192440 A1 Plasmadruglevel FIG . 1D over 1011 FIG . 2A %Release FIG . 2B Patent Application Publication Jun . 27 , 2019 Sheet 3 of 20 US 2019 /0192440 A1 203 202 201 * W e want to enter FIG . 3 Patent Application Publication Jun . 27 , 2019 Sheet 4 of 20 US 2019 /0192440 A1 ETVE WORLD 2X41 ter FIG . 4A HAFA 2222222222222222222 FIG . 4B WASCETTEV 2222 XaN FIG . 4C t. MAR res FIG . 4D Patent Application Publication Jun . 27 , 2019 Sheet 5 of 20 US 2019 /0192440 A1 ** * FIG . 4E yung ** * *** * * D L . SOLODRUG FLUID ansan k FIG . 5 Patent Application Publication Jun . 27 , 2019 Sheet 6 of 20 US 2019 /0192440 A1 300 ve 301 - 304 exames 302 LEEY T 'INNYA T?rne 1 DT FIG . 6 - 401 FIG . 7 Patent Application Publication Jun . 27 , 2019 Sheet 7 of 20 US 2019 /0192440 A1 *** * * * * * **22 * * * FIG . SA Kelease FIG . SB Patent Application Publication Jun . 27 , 2019 Sheet 8 of 20 US 2019 /0192440 A1 wordmoet wwwm . a son FIG . 9 Patent Application Publication Jun . 27 , 2019 Sheet 9 of 20 US 2019 /0192440 A1 700 -707 705 TTT 103 canli smo FIG . 10A FIG . 10B Patent Application Publication Jun . 27, 2019 Sheet 10 of 20 US 2019 /0192440 A1 *Release ti t2t3 FIG . 10C Plasandruglevel FIG . 10D Patent Application Publication Jun . 27, 2019 Sheet 11 of 20 US 2019 /0192440 A1 Prescription With Bacific doso said .* 19 ** * Patient FIG . 11 Patent Application Publication Jun . 27, 2019 Sheet 12 of 20 US 2019 /0192440 A1 XXXV FIG . 12A spot misrae***** *Release sünnitaminwist ir E FIG . 12B Patent Application Publication Jun . 27, 2019 Sheet 13 of 20 US 2019 /0192440 A1 900 900 - 902. 901 903 | | || TL II FIG . 13A rimitrittsitsi *Release p insmásitseine FIG . 13B Patent Application Publication Jun . 27, 2019 Sheet 14 of 20 US 2019 /0192440 A1 1000 - w . 1001 1002 - 1003 FIG . 14A CA 1102 _ 11031 FIG . 14B iero **** * *Release ingen susitsit FIG . 14C Patent Application Publication Jun . 27, 2019 Sheet 15 of 20 US 2019 /0192440 A1 1200 - 1201 JO . FIG . 15A Release uti . FIG . 15B Patent Application Publication Jun . 27, 2019 Sheet 16 of 20 US 2019 /0192440 A1 1300 1302 1303 wwware 1304 0918011301 www FIG . 16A *ReleaseSA FIG . 16B Patent Application Publication Jun . 27, 2019 Sheet 17 of 20 US 2019 /0192440 A1 1402 1400 1403 * 1401 imeno 1404 FIG . 17A re E * * rfsmeistos Release ** FIG . 17B *Release FIG . 17C Patent Application Publication Jun . 27, 2019 Sheet 18 of 20 US 2019 /0192440 A1 1500 1503 1502 ** Y : * FIG . 18A FIG . 18B Benzoic acid release percentage measured PBC8000 release percentage DRESUred by Gel Perseatich ReleasePercentage(%) Chronstography sazin?ts Helo se tice / & * X FIG . 18C Patent Application Publication Jun . 27, 2019 Sheet 19 of 20 US 2019 /0192440 A1 1600 FIG . 19A 1602 ***** * * * ** ***** * YKY FIG . 19B Patent Application Publication Jun . 27, 2019 Sheet 20 of 20 US 2019 /0192440 A1 0 . 30 0 . 25 0 . 20 Abs 0 . 15 0 . 10 0 .05 0 . 00 0 20 40 60 80 100 120 Time (min ) FIG . 190 Abs - 0 .02 20 40 60 80 100 Time (min ) FIG . 19D US 2019 /0192440 A1 Jun . 27 , 2019 ORAL DRUG DOSAGE FORM COMPRISING erodible polymer . In certain embodiments , the thermoplastic DRUG IN THE FORM OF NANOPARTICLES material is selected from the group consisting of polyvinyl caprolactam - polyvinyl acetate - polyethylene glycol graft CROSS -REFERENCE TO RELATED copolymer 57 / 30 / 13 , polyvinylpyrrolidone - co - vinyl- acetate APPLICATIONS (PVP - VA ), polyvinylpyrrolidone -polyvinyl acetate copoly mer (PVP - VA ) 60 / 40 , polyvinylpyrrolidone (PVP ), polyvi [ 0001 ] This application is a continuation of U . S . patent nyl acetate (PVAc ) and polyvinylpyrrolidone (PVP ) 80 / 20 , application Ser . No . 16 / 028 , 305 , filed Jul . 5 , 2018 , and Ser . polyethylene glycol- polyvinyl alcohol graft copolymer No . 15 / 173 , 596 , filed Jun . 3 , 2016 , which claims priority to 25 / 75 , kollicoat IR - polyvinyl alcohol60 /40 , polyvinyl alco U . S . Provisional Patent Application Ser. Nos . 62 / 170 ,645 , hol (PVA or PV -OH ), poly ( vinyl acetate ) (PVAc ), poly (butyl filed Jun . 3 , 2015 , 62 /296 , 087 , filed Feb . 17 , 2016 , and methacrylate- co - ( 2 -dimethylaminoethyl ) methacrylate - co 62 /313 , 092 , filed Mar. 24 , 2016 , the disclosures of which are methyl methacrylate ) 1 : 2 : 1 , poly (dimethylaminoethylmeth incorporated herein by reference in their entirety . acrylate - co -methacrylic esters ) , poly ( ethyl acrylate - co methyl methacrylate -co - trimethylammonioethyl FIELD OF THE INVENTION methacrylate chloride ) , poly (methyl acrylate - co -methyl [ 0002] The present invention generally relates to a phar methacrylate - co -methacrylic acid ) 7 : 3 : 1 , poly (methacrylic maceutical dosage form and controlled release of biologi acid - co -methylmethacrylate ) 1 : 2 , poly (methacylic acid - co cally active agents , diagnostic agents , reagents , cosmetic ethyl acrylate ) 1 : 1 , poly (methacylic acid - co -methyl meth agents , and agricultural/ insecticide agents . acrylate ) 1 : 1 , poly ( ethylene oxide ) (PEO ) , poly ( ethylene glycol ) (PEG ), hyperbranched polyesteramide , hydroxypro BACKGROUND pyl methylcellulose phthalate , hypromellose phthalate , [ 0003] Pharmaceutical drug products must be manufac hydroxypropyl methylcellulose or hypromellose (HMPC ) , tured into dosage forms in order to be marketed for use . hydroxypropyl methylcellulose acetate succinate or Conventional dosage forms typically involve a mixture of hypromellose acetate succinate (HPMCAS ) , poly ( lactide active pharmaceutical ingredients and inactive components co - glycolide ) (PLGA ) , carbomer, poly ( ethylene -co - vinyl ( excipients ) , along with other non - reusable materials such as acetate ), ethylene - vinyl acetate copolymer , polyethylene a capsule shell. Categories of dosage forms include liquid (PE ) , and polycaprolactone (PCL ) , hydroxyl propyl cellu dosage forms ( e . g ., solutions , syrups , elixirs , suspensions lose (HPC ) , Polyoxyl 40 Hydrogenerated Castor Oil, Methyl and emulsions ) , solid dosage forms ( e . g ., tablets , capsules , cellulose (MC ) , Ethyl cellulose ( EC ) , Poloxamer , hydroxy caplets and gel - caps ) , and semi- solid dosage form ( e . g ., propyl methylcellulose phthalate (HPMCP ) , Poloxamer, ointments and suppositories ), among which solid dosage Hydrogenated Castor & Soybean Oil, Glyceryl Palmitoste forms are more advantages to administer drugs in systemic arate , Carnauba Wax , polylactic acid ( PLA ), polyglycolic effect through oral route . acid (PGA ) , Cellulose acetate butyrate (CAB ) , Colloidal [0004 ] Tablets are most commonly used solid dosage Silicon , Dioxide , Sucrose , Glucose, Polyvinyl Acetate forms, which shows more benefits in terms ofmanufactur Phthalate (PVAP ) and a combination thereof. ing , packaging and shipping , and easy to identify and [ 0007 ] In certain embodiments , the compartment has a swallow . After being administered into a living organism , a shape selected from the group consisting of a pie shape , a tablet undergoes interplay with the body in exerting phar cone shape , a pyramid shape, a cylindrical shape , a cubic or maceutical effects . The active pharmaceutical ingredient cuboidal shape , a triangular or polygonal prism shape , a must be released from the tablet before being absorbed into tetrahedron and a combination thereof. the blood circulation . The pharmaceutical ingredient then f0008 ] In certain embodiments , the first drug content is in disperses , disintegrates or dissolves throughout the fluids a form of nanoparticles , microneedles or forms a net . and tissues of the body. During drug absorption, disposition , [0009 ] In certain embodiments , the drug content com metabolism , and elimination process , dosage forms play a prises
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    ACACETIN ACEBUTOLOL HYDROCHLORIDE ACECLIDINE HYDROCHLORIDE ACEMETACIN ACETAMINOPHEN ACETAMINOSALOL ACETANILIDE ACETARSOL ACETAZOLAMIDE ACETOHYDROXAMIC ACID ACETRIAZOIC ACID ACETYL TYROSINE ETHYL ESTER ACETYLCARNITINE ACETYLCHOLINE ACETYLCYSTEINE ACETYLGLUCOSAMINE ACETYLGLUTAMIC ACID ACETYL-L-LEUCINE ACETYLPHENYLALANINE ACETYLSEROTONIN ACETYLTRYPTOPHAN ACEXAMIC ACID ACIVICIN ACLACINOMYCIN A1 ACONITINE ACRIFLAVINIUM HYDROCHLORIDE ACRISORCIN ACTINONIN ACYCLOVIR ADENOSINE PHOSPHATE ADENOSINE ADRENALINE BITARTRATE AESCULIN AJMALINE AKLAVINE HYDROCHLORIDE ALANYL-dl-LEUCINE ALANYL-dl-PHENYLALANINE ALAPROCLATE ALBENDAZOLE ALBUTEROL ALEXIDINE HYDROCHLORIDE ALLANTOIN ALLOPURINOL ALMOTRIPTAN ALOIN ALPRENOLOL ALTRETAMINE ALVERINE CITRATE AMANTADINE HYDROCHLORIDE AMBROXOL HYDROCHLORIDE AMCINONIDE AMIKACIN SULFATE AMILORIDE HYDROCHLORIDE 3-AMINOBENZAMIDE gamma-AMINOBUTYRIC ACID AMINOCAPROIC ACID N- (2-AMINOETHYL)-4-CHLOROBENZAMIDE (RO-16-6491) AMINOGLUTETHIMIDE AMINOHIPPURIC ACID AMINOHYDROXYBUTYRIC ACID AMINOLEVULINIC ACID HYDROCHLORIDE AMINOPHENAZONE 3-AMINOPROPANESULPHONIC ACID AMINOPYRIDINE 9-AMINO-1,2,3,4-TETRAHYDROACRIDINE HYDROCHLORIDE AMINOTHIAZOLE AMIODARONE HYDROCHLORIDE AMIPRILOSE AMITRIPTYLINE HYDROCHLORIDE AMLODIPINE BESYLATE AMODIAQUINE DIHYDROCHLORIDE AMOXEPINE AMOXICILLIN AMPICILLIN SODIUM AMPROLIUM AMRINONE AMYGDALIN ANABASAMINE HYDROCHLORIDE ANABASINE HYDROCHLORIDE ANCITABINE HYDROCHLORIDE ANDROSTERONE SODIUM SULFATE ANIRACETAM ANISINDIONE ANISODAMINE ANISOMYCIN ANTAZOLINE PHOSPHATE ANTHRALIN ANTIMYCIN A (A1 shown) ANTIPYRINE APHYLLIC
  • Tanibirumab (CUI C3490677) Add to Cart

    Tanibirumab (CUI C3490677) Add to Cart

    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor