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IPR2019-00449, No. 1026-42 Exhibit - Kibbe, editor, Handbook of Pharmaceutical Excipients, Third Edition 2000, American Pharmaceutical Association, Washington DC Kibbe (P.T.A.B. Jan. 28,...
The publisher makes no representation, express or ot accept any legal responsibility or implied, with regard to the accuracy of the information contained in this book and canu liability for any errors or omissions that may be made.
Applications in Pharmaceutical Formulation or Technology Alpha tocopherol is primarily recognized as a source of vi— tamin E and the commercially available materials and speci- fications reflect this purpose.
Comments: «tocopherois excipient is described in the USP as a vegetable oil solution containing not less than 50.0% of total tocopherois, of which not less than 80.0% consists of varying amounts of beta, delta, and gamma tocopherols.
(5] However, a 2% v/v aqueous solution in a polyethylene cone tainer, stored at 20°C, may lose up to 15% of its benzyl alu coho] content in 13 weeksml Losses to polyvinyl chloride and polypropylene containers under similar conditions are usually 13.
Regulatory Status Included in the FDA Inactive Ingredients Guide (injections, oral capsules, solutions and tablets, topical, and vaginal prep- arations).
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IPR2019-00449, No. 1026-42 Exhibit - Kibbe, editor, Handbook of Pharmaceutical Excipients, Third Edition 2000, American Pharmaceutical Association, Washington DC Kibbe (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1042-60 Exhibit - PDR 54th Edition 2000, DIASTAT¿¿ diazepam rectal gel MIACALCIN¿¿ Calcitonin Nasal Spray VALIUM¿¿ diazepam injection, Physicians¿¿¿ Desk Reference (P...
None of the content of this publication may be reproduced, stored in a retrieval system, resold, redistributed, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior ...
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IPR2019-00449, No. 1042-60 Exhibit - PDR 54th Edition 2000, DIASTAT¿¿ diazepam rectal gel MIACALCIN¿¿ Calcitonin Nasal Spray VALIUM¿¿ diazepam injection, Physicians¿¿¿ Desk Reference (P.T.A.B. Jan. 2
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IPR2019-00449, No. 1003-4 Exhibit - US Patent No 8,895,546, Administration Of Benzodiazepine Compositions, filed June 13, 2012 ¿¿¿546 Patent (P.T.A.B. Jan. 28, 2019)
In this context, it is intended that bioavail- ability be determined by a suitable pharmacodynamic method, such as comparison of area under the blood plasma concentration curve (AUC) for the nasally and intravenously administered drug.
In some embodiments, the composition consists essentially of a benzodiazepine drug that is fully dissolved in a solvent con- sisting of one or more natural or synthetic tocopherols or tocotrienols, one or more alcohols or glycols, and optionally one or more alkyl glycosides wherein the solution is at least substantially free of water.
In some embodiments, the composition consists essentially of a benzodiazepine drug that is fully dissolved in a solvent con- sisting of one or more natural or synthetic tocopherols or tocotrienols, one or more alcohols or glycols, and optionally one or more alkyl glycosides.
drug in a form including benzodiazepine microparticles and/ or nanoparticles suspended in a carrier system comprising Vitamin E TPGS, methylparaben, propylparaben, propylene glycol, povidone and water.
In some embodiments, the composition con- sists of a benzodiazepine drug in a form including benzodi- azepine microparticles and/or nanoparticles suspended in a carrier system consisting ofVitamin E TPGS, methylparaben, propylparaben, propylene glycol, povidone and water.
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IPR2019-00449, No. 1003-4 Exhibit - US Patent No 8,895,546, Administration Of Benzodiazepine Compositions, filed June 13, 2012 ¿¿¿546 Patent (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1004-6 Exhibit - Part 2 ¿¿¿ Pages 351 700 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 28, 2019)
Noneof these references, or any other reference that describes nanoparticulate compositions, relates to a nanoparticulate composition having a combination of immediate release and controlled release characteristics.
None of the described prior art teaches an immediate release dosage form in which a poorly soluble active ingredient is in a nanoparticulate form.
For compoundsof the formula NRyR»R3R4”: 10 {i} (ii) (iii) (iv) (v} 15 none of R1-R4 are CH3; one of Ry-R4 is CH; three of Ry-Ry are CH3; all of Ry-Rg are CH; two of R,-Ryz are CHs, one of Ry-Ry is CgHsCHo, and one of Ry-Ry is an alkyl ...
Noneofthese references describe nanoparticulate active agent compositions comprising a peptide surface stabilizer.
For compoundsofthe formula NR:RoR3Ry?: (i) none of R ...
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IPR2019-00449, No. 1004-6 Exhibit - Part 2 ¿¿¿ Pages 351 700 File History for ¿¿¿546 Patent, Ser No 13495,942 ¿¿¿546 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1007-16 Exhibit - Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1007-16 Exhibit - Part 2 ¿¿¿ Pages 401 800 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1008-24 Exhibit - Provisional Patent Application No 61040,558, filed March 28, 2008 ¿¿¿558 Provisional (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1008-24 Exhibit - Provisional Patent Application No 61040,558, filed March 28, 2008 ¿¿¿558 Provisional (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1007-18 Exhibit - Part 4 ¿¿¿ Pages 1201 1600 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019...
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IPR2019-00449, No. 1007-18 Exhibit - Part 4 ¿¿¿ Pages 1201 1600 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1020-36 Exhibit - Meezan et al, US Patent No 5,661,130, Absorption Enhancers For Drug Administration, issued August 26, 1997 Meezan¿¿¿130 (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1020-36 Exhibit - Meezan et al, US Patent No 5,661,130, Absorption Enhancers For Drug Administration, issued August 26, 1997 Meezan¿¿¿130 (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1023-39 Exhibit - Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 Bioavailability and Bioequivalence, Drug Intelligence Publications, Illinois, 1992 Ritschel (P.T.A...
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IPR2019-00449, No. 1023-39 Exhibit - Ritschel, Handbook of Basic Pharmacokinetics, Chapter 36 Bioavailability and Bioequivalence, Drug Intelligence Publications, Illinois, 1992 Ritschel (P.T.A.B. Jan.
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IPR2019-00449, No. 1041-59 Exhibit - Declaration of Dr Nicholas A Peppas (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1041-59 Exhibit - Declaration of Dr Nicholas A Peppas (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1007-17 Exhibit - Part 3 ¿¿¿ Pages 801 1200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1007-17 Exhibit - Part 3 ¿¿¿ Pages 801 1200 File History for Non Provisional Patent Application Serial No 12413,439, filed March 27, 2009 ¿¿¿439 FH (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1037-53 Exhibit - Colombo, Mucosal Drug Delivery, Nasal, pp 592 605, Vol 2, Encyclopedia of Controlled Drug Delivery Mathiowitz, editor, John Wiley Sons, 1999 Colombo (P...
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IPR2019-00449, No. 1037-53 Exhibit - Colombo, Mucosal Drug Delivery, Nasal, pp 592 605, Vol 2, Encyclopedia of Controlled Drug Delivery Mathiowitz, editor, John Wiley Sons, 1999 Colombo (P.T.A.B. Jan
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IPR2019-00449, No. 1031-47 Exhibit - Rowe et al, editors, Handbook of Pharmaceutical Excipients, 2003, 4th Edition, ¿¿¿Alcohol¿¿¿ ie, ethanol, American Pharmaceutical Association Rowe (P.T.A...
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IPR2019-00449, No. 1031-47 Exhibit - Rowe et al, editors, Handbook of Pharmaceutical Excipients, 2003, 4th Edition, ¿¿¿Alcohol¿¿¿ ie, ethanol, American Pharmaceutical Association Rowe (P.T.A.B. Jan. 2
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IPR2019-00449, No. 1018-34 Exhibit - Tenta, US Patent No 3,949,072, Seborrheic Keratosis Treatment, issued April 6, 1976 Tenta (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1018-34 Exhibit - Tenta, US Patent No 3,949,072, Seborrheic Keratosis Treatment, issued April 6, 1976 Tenta (P.T.A.B. Jan. 28, 2019)
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IPR2019-00449, No. 1024-40 Exhibit - Osborne et al, Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 Osborne (P.T.A.B. Jan. 28, 201...
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IPR2019-00449, No. 1024-40 Exhibit - Osborne et al, Skin Penetration Enhancers Cited in the Technical Literature, Pharmaceutical Technology, November 1997 Osborne (P.T.A.B. Jan. 28, 2019)
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