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WO 2018/004576 A2 04 January 2018 (04.01.2018) W !P O PCT

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WO 2018/004576 A2 04 January 2018 (04.01.2018) W !P O PCT (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/004576 A2 04 January 2018 (04.01.2018) W !P O PCT (51) International Patent Classification: Declarations under Rule 4.17: A61K 9/70 (2006.01) — as to applicant's entitlement to applyfor and be granted a (21) International Application Number: patent (Rule 4.1 7(H)) PCT/US20 16/040228 — of inventorship (Rule 4.1 7(iv)) (22) International Filing Date: Published: 30 June 2016 (30.06.2016) — without international search report and to be republished upon receipt of that report (Rule 48.2(g)) (25) Filing Language: English (26) Publication Language: English (71) Applicant: TAHO PHARMACEUTICALS LTD.; 3rd Fl, No. 550, Ruiguang Rd, Neihu District, Taipei, 114 (TW). (72) Inventors: WANG, Chien-Chiao; 3F, No. 126, Sanmin Rd., Luzhou District, New Taipei City, 247 (TW). LIN, Fang-Chu; No. 122 Chaha'er 2nd Street, Samin Dis trict, Kaohsiung City, 807 (TW). LEE, Catherine; 3852 Fairhaven Dr., West Linn, OR 97068 (US). (74) Agent: HSU, Rei-Cheng; No. 20-1, Lane 61, LinYi Rd., Taipei, 100 (TW). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). < (54) Title: A FAST ACTING ORALLY DISINTEGRATING FILM FOR ADMINISTRATION OF LOCAL ANESTHESIA (57) Abstract: A fast acting orally disintegrating film (ODF) for administration of local anesthetic for alleviating physical and psycho logical discomfort in the oral cavity during procedures such as dental procedures or for relieving pain generally such as toothaches. The ODF comprises an active pharmaceutical ingredient such as lidocaine free base or a pharmaceutically acceptable salt thereof in a o therapeutically acceptable amount such as about 24 mg, at least one primary hydrophilic film forming polymer, at least one secondary © hydrophilic film forming polymer, wherein the ratio of the primary hydrophilic film forming polymer to the secondary hydrophilic film 0 0 forming polymer is about 1 : 1 to about 20: 1 by weight. The ODF further comprises a plasticizer wherein the ratio of the total weight o of primary and secondary hydrophilic film forming polymer to the weight of the plasticizer is about 4: 1 to about 4:3. A FAST ACTING ORALLY DISINTEGRATING FILM FOR ADMINISTRATION OF LOCAL ANESTHESIA FIELD OF THE INVENTION The present invention relates to a fast acting orally disintegrating film (ODF) containing lidocaine, uses thereof and a method of producing the ODF. BACKGROUND OF THE INVENTION Local anesthetics are drugs used for mitigating pain sensation at site of administration. An example of a local anesthetic is lidocaine with chemical name acetamide 2-(diethylamino)-N- (2,6-dimethylphenyl). Lidocaine is often used in dentistry to alleviate physical discomfort as well as psychological tension in patients during dental procedures such as oral surgery, tooth extraction, root canal as well as to mitigate pain from toothaches, oral ulcers, cold sores or teething etc. ... For the dental procedures, lidocaine is commonly administered by injection such as "Xylocaine® Cartridge for Dental Use" (Fujisawa Pharmaceutical Co., Ltd.). However, the invasive nature of the injection can itself cause both physical as well as psychological discomfort for the patient. In addition, for applications aside from dental procedures such as alleviation of pain from toothaches, a non-invasive form of administration is usually preferred. Furthermore, a method of administering lidocaine that is quick to provide therapeutic effect is beneficial for both doctors as well as patients. Therefore, there is a need for a method for administration of local anesthetic that is both non-invasive as well as fast acting. SUMARY OF THE INVENTION Accordingly, it is one objective of the present invention to provide a fast acting orally disintegrating film (ODF) for administration of local anesthetic. The present invention provides a fast acting ODF comprising lidocaine free-base or a pharmaceutically acceptable salt thereof, at least one primary film-forming polymer, at least one secondary film-forming polymer and at least one plasticizer, wherein the primary film-forming polymer and the secondary film-forming polymer are present at a ratio of about 1:1 to 20:1 by weight and wherein the primary film-forming polymer and the secondary film-forming polymer are hydrophilic. In some embodiments, the pharmaceutically acceptable lidocaine salt comprises lidocaine hydrochloride. In another embodiment, the lidocaine is present at an amount comprising at least about 10% to about 20% by dry weight of said film. In yet another embodiment, the primary film-forming polymer comprises hydroxylpropyl cellulose (HPC) or hydroxylpropyl methylcellulose (HPMC). In some embodiments, the secondary film-forming polymer comprises HPC, HPMC, pullulan and/or povidone (PVP). In another embodiment, the HPMC comprises HPMC 3cps, HPMC 6cps or HPMC 15cps. In yet another embodiment, the PVP comprises PVP K-30 or PVP K-90. In some embodiments, the at least one plasticizer comprises polyethylene glycol (PEG), glycerol or Tween 20. In another embodiment, the PEG comprises PEG 400, PEG 4000 and/or PEG 6000. In some embodiments, the dry weight of the primary polymer as compared to dry weight of the secondary polymer is in a ratio of about 1:1 to about 7:1. In another embodiment, the dry weight of the primary and secondary polymers as compared to the dry weight of the plasticizer are in a ratio of about 4:1. In yet another embodiment, the primary polymer comprises HPMC 6cps and the plasticizer comprises a plasticizer with high viscosity above about 500cps but below about 2000 cps and low molecular weight of below about 1000 Daltons. In some embodiments, the primary polymer comprises HPMC 15cps and the plasticizer comprises a plasticizer with low viscosity below about 200 cps but above 3cps and high molecular weight of above about 5000 Daltons but below about 5,000,000 Daltons. In other embodiments, the primary polymer comprises HPMC 15cps, the secondary polymer comprises HPMC 3cps or HPMC 6cps and the plasticizer comprises glycerol or PEG 6000, wherein the primary film-forming polymer, the secondary film-forming polymer and the plasticizer are present at a ratio of about 2:2:1 to about 7:1:2 by weight. In yet another embodiment, the primary polymer comprises HPMC 15cps, the secondary polymer comprises HPMC 3cps, HPMC 6cps or pullulan and the plasticizer comprises PEG 6000, wherein the primary film-forming polymer, the secondary film-forming polymer and the plasticizer present at a ratio of about 3:1:1 by weight. In some embodiments, the primary polymer comprises HPMC 6cps, the secondary polymer comprises HPMC 3cps or pullulan and the plasticizer comprises glycerol wherein the primary film-forming polymer, the secondary film-forming polymer and the plasticizer present at a ratio of about 3:1:1 by weight. In another embodiment, the primary polymer comprises HPMC 6cps, the secondary polymer comprises PVP K-90 and the plasticizer comprises PEG 4000 wherein the primary film-forming polymer, the secondary film-forming polymer and the plasticizer present at a ratio of about 7:1:2 by weight. In some embodiments, the fast acting ODF disintegrates within about 60 seconds of administration. In other embodiments, the dissolution rate of the fast acting ODF allows for release of about 90% of the lidocaine within about 5 minutes to about 10 minutes of administration. In yet another embodiments, the permeation rate of the fast acting ODF allows about 0.8 to about 1.7 mg/cm2 of lidocaine to permeate through the targeted area treated with the ODF within about 5 minutes of administration. In some embodiments, no trace of organic solvent is present in the composition. In some embodiments, the orally disintegrating film is produced by a method comprising the steps of mixing the local anesthetic, the two polymers and the at least one plasticizer in an aqueous solution, transferring the aqueous solution to a surface of a suitable carrier material and drying the aqueous solution on surface of the carrier material to form a film. The present invention also provides a method for providing local anesthesia to a patient in need, the method comprising: orally administering to the patient in need thereof an effective amount of a composition comprising lidocaine free-base or a pharmaceutically acceptable salt thereof, at least one primary film-forming polymer, at least one secondary film-forming polymer and at least one plasticizer, wherein the primary film-forming polymer and the secondary film-forming polymer are present at a ratio of about 1:1 to 20:1 by weight and wherein the primary film-forming polymer and the secondary film- forming polymer are hydrophilic.
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