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(12) Patent Application Publication (10) Pub. No.: US 2010/0159007 A1 Staniforth (43) Pub US 20100159007A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0159007 A1 Staniforth (43) Pub. Date: Jun. 24, 2010 (54) PHARMACEUTICAL COMPOSITIONS FOR (30) Foreign Application Priority Data TRANSMUCOSAL DELIVERY OFA THERAPEUTICALLY ACTIVE AGENT ON Dec. 19, 2006 (GB) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - O625322.3 THE BASIS OF SUBMCRON PARTICLES O O Publication Classification (75) Inventor: John Nicholas Staniforth, Bath (51) Int. Cl. (GB) A6IR 9/14 (2006.01) C d Add A63L/404 (2006.01) orrespondence CSS Davidson, Davidson & Kappel, LLC (52) U.S. Cl. .......................... 424/484; 424/489: 514/415 485 7th Avenue, 14th Floor (57) ABSTRACT New York, NY 10018 (US) The present invention relates to improved compositions for (73) Assignee: PHARMAKODEX LIMITED, transmucosal administration, the compositions enabling Bath (GB) rapid and efficient uptake of a therapeutically active agent to provide a rapid, effectively durable, predictable and consis (21) Appl. No.: 12/520,417 tent therapeutic effect. In particular, the compositions are intended for buccal and/or sublingual delivery. The invention (22) PCT Filed: Dec. 19, 2007 is particularly suitable for administering therapeutically active agents which have an effect on the central nervous (86). PCT No.: PCT/GB2OOTAOSO766 system and even more particularly where rapid onset of this effect is desired or beneficial. The invention is also particu S371 (c)(1), larly Suitable for administering active agents in low solubility (2), (4) Date: Jan. 25, 2010 base or acid forms. Patent Application Publication Jun. 24, 2010 Sheet 1 of 9 US 2010/O159007 A1 {}{}{}{}? Patent Application Publication Jun. 24, 2010 Sheet 2 of 9 US 2010/O159007 A1 {}{}{}{}}. |(lugzeugz)901m-wººgzno?i?gwºprooeae-1 |(lugz/bugz)goin-vg-szol?ºvepropeº-------||(lugz/bugz)goin-ºgrszowi?zvepropes—| Patent Application Publication Jun. 24, 2010 Sheet 3 of 9 US 2010/O159007 A1 9'91-' (ugurp)ºzis |(lugz/bugz)901n-v9/92/01+8×8propeº}|(lugz/bugz)90.ln-vg-szowi?6vepropes------- |(lugz/bugz)9oin-ºgrszowi?ogepropeº— (%) Asieu Patent Application Publication Jun. 24, 2010 Sheet 5 of 9 US 2010/O159007 A1 -43 : Sumatript&n 833e - F.G. 5 -6 crowdextesso N '. 3.8 kg East &aycroRs^ 8 g attof $ 2 8 g Sween 80 N3.2a-------------------------------- kg Purified water/ S8 &:right Ray aspeak: a 38-33's 36 g - plac 5 Sir 8: 8xxx 8:38;s&e 3.28°C; 3: for : 3:3 to practice at: :::::: Sassession Real terrperature (38-38&} EAC S.SENSE AQUEous solution 8 a .88 SSSSSE3, its S.38: 3 3: 33 ξ te:a::ge 33-33°3 33 EYES S3. spray oryne RCESS &pray digi: 8x8; 33.8e &ntis:::::c 8: 833 &eighing K82 AXS NES : Patent Application Publication Jun. 24, 2010 Sheet 6 of 9 US 2010/O159007 A1 { 8 : { s issalation: tire air ** 8atch 3sixt x ** 88tc. 3 *&act { *8ate 8 Patent Application Publication Jun. 24, 2010 Sheet 7 of 9 US 2010/O159007 A1 FG. 7 53% ww vesses : 3 & 80% wiw vesses 4-6 Spray Died 20 3racetarro if J. C. 8. is 80 -(-Wessel S; --Wesse 2 & ex-Wessei 3 -k-Wesse 4 20 ~x-vesse 5 f --vesse 6 o t 2 3. fine inities: 53% wiw Wesses : 3 & 80% wiw (Wesses 4-8) Spray Rieg 13, -Paracetano in Water 3. & asses E. s e resexes s 8 S. is 60 -K-Wesse: ; -O-Wesse 3 at . -ss-vesse: 3 ox-Wesse 4 --vesse 5 -0-vessel 6 stresserrerrer 10 2} 3. ine rhinutes) Patent Application Publication Jun. 24, 2010 Sheet 8 of 9 US 2010/O159007 A1 FIG 1 O 3S3: 48% $::matripter saro particis terriation * i-pressesse: 83ratsitar 333 "Baik {33 2008 t {{ s : 3. - so 20 3. & so 60 Tinas (h Patent Application Publication Jun. 24, 2010 Sheet 9 of 9 US 2010/O159007 A1 US 2010/O 159007 A1 Jun. 24, 2010 PHARMACEUTICAL COMPOSITIONS FOR ity in the pharmacokinetic absorption and in pharmacody TRANSMUCOSAL DELVERY OFA namics which has an impact on the efficacy of the absorbed THERAPEUTICALLY ACTIVE AGENT ON active agent. THE BASIS OF SUBMCRON PARTICLES 0005 GI administration of pharmaceutical compositions may also be adversely affected by GI disturbances (including nausea and Vomiting). These conditions (which may be related to the condition to be treated by the pharmaceutical 0001. The present invention relates to improved composi composition, or may actually be caused by the composition tions for transmucosal administration, the compositions being administered) lead to uncertainty as to the dose deliv enabling rapid and efficient uptake of a therapeutically active ered, as well as variable absorption and efficacy of the dose agent to provide a rapid, effectively durable, predictable and that is delivered. consistent therapeutic effect. In particular, the compositions 0006. Upon administration of a pharmaceutical composi are intended for buccal and/or sublingual delivery of the tion to the GI tract, the composition and the active agent active agent. The invention is particularly suitable for admin contained therein will be exposed to acids and enzymes which istering therapeutically active agents which have an effect on can cause degradation of the active agent and therefore result the central nervous system and even more particularly where in variable and reduced drug efficacy. rapid onset of this effect is desired or beneficial. The invention 0007 Administration of a therapeutically active agent via is also particularly suitable for administering active agents in the GI tract may also be adversely affected by efflux and/or low solubility base or acid forms. metabolism as the active agent crosses the GI mucosa or in the 0002 Whilst the pharmacologically active form of many liver (entero-hepatic metabolism). This can lead to abnor drugs is the base chemical form, or in a smaller number of mally low, or otherwise poor bioavailability or variable dis cases the acid chemical form, it is uncommon for these tribution, metabolism and/or excretion of the active agent due chemical forms to be administered to mammals, including to effects generally referred to as “first-pass metabolism. human mammals, via the peroral route, due to the low and 0008 Finally, in some cases, for example where the active often variable solubility of these chemical forms of the active agent is subject to active transport across the GI tract, includ agent in the fluid of the gastro-intestinal (GI) tract. The lower ing Saturable transport mechanisms, or is a cytochrome P450 and potentially variable solubility characteristics of many or other metabolism inhibitor, one active agent can block base and certain acid chemical forms of active agents in GI absorption or metabolism of the same or another therapeutic fluid has meant that pharmaceutical products are instead agent. This can lead to undesirable and potentially dangerous developed including a salt form or sometimes an esterform of drug interactions when such drugs are administered to the GI these active agents. For example, less Soluble base forms of tract active agents are frequently converted into a more soluble 0009. Some or all of these disadvantages associated with hydrochloride salt form for improved aqueous solubility and/ oral administration and absorption of the active agent via the or solution rate, and/or reduced solubility variability in order GI tract may be overcome by adopting a pre-gastric transmu to improve pharmacokinetic or other bioavailability param cosal route of delivery. It is well established that the rate of eters following peroral administration of a medicament con active agent uptake across the buccal, Sublingual, oesoph taining the active agent. In the case of poorly soluble acid ageal, pharyngeal, nasal and pulmonary mucosa can be much forms of drugs, these may be converted, for example, into the faster than that observed as a result of administration via the sodium salt of the acid chemical form in order to improve GI tract. Furthermore, where the active agent is able to rapidly aqueous solubility and/or solution rate, and/or reduced solu transfer into the systemic circulation from these mucosa, bility variability following peroral administration of a medi especially from the buccal cavity (including the Sublingual cament containing the active agent. However, once absorbed area), this avoids one or more of “food effects”, entero-he into the bloodstream of a patient, dissociation of the free base patic metabolism, active transport across GI tract and/or cyto or acid chemical form of the drug must usually occur as a chrome-mediated metabolism resulting from transfer across precursor to pharmacological activity. In cases where rapid GI tract, GI disturbances (including reduced or variable GI onset and/or central (CNS) therapeutic action is desired, the motility, absorption, nausea or Vomiting) and GI degradation. ability to deliver the immediately pharmacologically active 0010. As a result, transmucosal administration has the base, or sometimes acid, chemical form of the drug into the potential to provide drug delivery with great reproducibility, bloodstream and where appropriate the cerebrospinal fluid, efficiency and rapid onset of action. However, known formu would be advantageous if the problem of poor solubility lations provided for transmucosal delivery suffer from prob leading to poor and/or variable peroral drug absorption could lems that mean that the therapeutic potential of this route of be overcome. In consequence, many drugs have never been administration has not yet been fully realised. administered to humans, have never been administered via 0011 Formulations for oral transmucosal delivery via the the peroral route or have never been manufactured, registered Sublingual or buccal mucosa are known but they often result or sold as medicines or peroral medicines except in a salt in the majority of active agent dose being Swallowed and form. thereby being absorbed non-locally in the GI tract, resulting 0003) Whilst peroral administration leading to absorption in a slow and variable therapeutic effect.
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