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|I|||||||||||III USOO5418253A United States Patent (19) 11 Patent Number: 5,418,253 Cavazza Et Al

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|I|||||||||||III USOO5418253A United States Patent (19) 11 Patent Number: 5,418,253 Cavazza Et Al |I|||||||||||III USOO5418253A United States Patent (19) 11 Patent Number: 5,418,253 Cavazza et al. 45 Date of Patent: May 23, 1995 54 ESTERS OFL-CARNITINE AND ALKANOYL (56) References Cited L-CARNITNES WITH GLYCOLIC ACD OR U.S. PATENT DOCUMENTS ESTERS THEREOF AND PHARMACEUTICAL COMPOSITIONS 4,439,438 3/1984 Cavazza .............................. 424/263 4,443,475 4/1984 Cavazza ...... ... 560/170 CONTAINING SAME FORTREATING 4,743,621 5/1988 Cavazza .. ... 514/547 DERMATOSES 5,246,967 9/1993 Zezza .................................. 514/547 75 Inventors: Claudio Cavazza; Paolo Cavazza, FOREIGN PATENT DOCUMENTS both of Rome, Italy 902796 7/1985 Belgium. 73) Assignee: Avantgarde S.p.A., Rome, Italy 903270 3/1986 Belgium. 429403 5/1991 European Pat. Off. (21) Appl. No.: 280,663 442850 8/1991 European Pat. Off. 443996 8/1991 European Pat. Off. 22 Filed: Jul. 27, 1994 8502578 4/1987 Netherlands. Related U.S. Application Data Primary Examiner-José G. Dees Assistant Examiner-Samuel Barts 63 Continuation of Ser. No. 138,103, Oct. 20, 1993, aban Attorney, Agent, or Firm-Oblon, Spivak, McClelland, doned. Maier & Neustadt 30 Foreign Application Priority Data 57 ABSTRACT Oct. 20, 1992 IT Italy ............................. RM92AO761 Ester of L-carnitine and alkanoyl L-carnitines with 511 Int. Cl............................................. A61K 3/225 glycolic acid and esters thereof are disclosed, which are 52 U.S. C. .................................... 514/547; 514/561; formulated into topically applicable pharmaceutical 560/170,562/567 compositions for the treatment of dermatoses. 58) Field of Search ........................ 560/170,562/567; 514/547,561 6 Claims, No Drawings 5,418,253 1. 2 manifestation of a tumor process involving internal ESTERS OFLCARNITINE AND ALKANOYL Organs. LCARNTINES WITH GLYCOLIC ACID OR Xeroderma, the mildest form of ichthyosis is neither ESTERS THEREOF AND PHARMACEUTICAL congenital nor associated with systemic abnormalities. COMPOSITIONS CONTAINING SAME FOR 5 It usually occurs on the lower legs of middle-aged or TREATING DERMATOSES older patients, most often in cold weather and in pa This application is a continuation of application Ser. tients who bathe frequently. There may be mild to mod No. 08/138,103, filed on Oct. 20, 1993, now abandoned. erate itching and an associated dermatitis due to deter The present invention relates to esters of L-carnitine 10 gents or other irritants. and alkanoyl L-carnitines with glycolic acid or esters of The inherited ichthyoses, all characterized by exces glycolic acid and pharmaceutical compositions which sive accumulation of scale on the skin surface, are classi contain such esters as active ingredients, suitable to be fied according to clinical, genetic, and histologic crite topically applied for the treatment of dermatoses. at The esters of the present invention have the general 15 Known treatments of any form of ichthyosis com formula (I) prise topically applying to the skin hydrating emol lients. Furthermore, salicylic acid or vitamin A-contain ing ointments have been widely used. A keratolytic agent particularly effective in removing 20 CHGSN1\°-1Mx or, the scale in ichthyosis vulgaris, lameliar ichthyosis and CH3 o, O sex-linked ichthyosis contains 6% salicylic acid in a gel R composed of propylene glycol, ethyl alcohol, hydroxy propylene cellulose and water. wherein: Further known drugs for the treatment of this disor R is hydrogen or a straight or branched alkanoyl 25 der include: 50% propylene glycol in water, hydro group having 2-5 carbon atoms; philic petrolatum and water (in equal parts), and cold R1 is hydrogen or a straight or branched alkyl group cream and an a-hydroxy acid (e.g. lactic and pyruvic having 1-4 carbon atoms; and acid) in various bases. In lameliar ichthyosis, 0.1% treti X is the anion of a pharmacologically acceptable 30 noin (vitamin A acid; retinoic acid) cream has been salt. utilized. Encompassed by the compounds of the present in None of these treatments has been found satisfacto vention are also the inner salts of the compounds of the rily effective. general formula (I), having the general formula (I) Hyperkeratosis is a thickening of the stratum cor 35 neum of the skin. The treatment of choice is the topical CH3 O (I) application of drugs containing urea, propylene glycol N+ ous or salicylic acid. Also in this case, none of the known CHGN1\1\/ O treatment has proved to be satisfactorily effective. CH3 o, O It has now been found that the compounds of the R present invention, when topically applied as solutions, lotions, creams or ointments containing from 0.01% to If R is an alkanoyl, it is preferably selected from acetyl, propionyl, butyryl, isobutyryl, valleryl and isovaleryl. 20%, preferably from 1% to 15% and most preferably If R1 is an alkyl, it is preferably selected from methyl, from 2 to 10% by weight of a least one of the foregoing n-butyl and tert-butyl. 45 compounds, are potently effective in achieving com Pharmaceutically acceptable salts of the compound plete remission of ichthyotic conditions in humans and of formula (I) include, in addition to the inner salts, all in healing psoriasis and those disorders brought about pharmaceutically acceptable salts which are prepared by an altered keratinization, such as dandruff, acne and by the addition of acid to L-carnitine, and which do not palmar and plantar hyperkeratosis. give rise to undesirablie toxic or collateral effects. The 50 It has also been found that, if the solutions, creams or formation of pharmaceutically acceptable acid addition ointments of the invention are applied regularly on a salts is well known in pharmaceutical techonology. daily basis, within about two to three weeks the effected Non-limiting examples of suitable salts include the skin areas will return to norm conditions. chloride, bromide, orotate, acid aspartate, acid citrate, The compounds of formula (I) are prepared via a acid phosphate, fumarate, acid fumarate, lactate, male 55 process whose steps are illustrated in the following ate, acid maleate, acid oxalate, acid sulfate, glucose reaction scheme, wherein R, R1 and X have the previ phosphate, tartrate and acid tartrate salts. ously defined meanings. The dermatoses which are suitably treated with the compositions of the present invention are in particular ichthyosis, psoriasis and those dermatoses which are 60 induced by a defective keratinization, such as dandruff, CR -- acne and palmar and plantar hyperkeratosis. cis-N-N- -- Br-1a OR CH3 O O Ichthysosis is a dermatosis characterized by general N ized dryness, harshness and scaling of the skin. It may R occur as a hereditary disease present at birth, or as a (II) (III) metabolic disorder associated with hypothyroidism or with the intake of drugs (such as butyrophenols) inhibit ing lipid synthesis, or as a paraneoplastic syndrome, y 5,418,253 3. 4. ethyl ether under vigorous stirring for one hour, at 25 -continued C., resulting into a crystalline precipitate. CR -- The precipitate was quickly filtered and the residual CHGSN1)--N1 N OR solvent removed at 35° C. under reduced pressure. 15g c?B O O 5 of the title compound (M.W. 356,26) were obtained as a N colourless solid. Yield 84.2%. R M.P.. 100-101 C. a25D= - 10.3 (C= 1 in H2O) (IV) TLC: single spot (eluant CHCl3:MeOH:isoPrOH :AcOH 60:40:15:10:15) . O Silica gel plates 0.25 mm-60F254 (E. Merck) Detectors U.V.W. = 254 nm and iodine vapours Elementary Analysis (C13H26BrNOs) M.W. 356.26 Crs - CHS11N ON1N OR cí. X I 15 3 N calc. 2% C 43.88 H 7.36 Br 22.43 N 3.93 R found. 26 C 43.77 H 7.44 B. 22.35 N 3.78 HPLC Waters: spherisorb column RP1 (5), (I) inner diameter = 4 mm ... 20 length = 125 mm More specifically, carnitine or the alkanoylcarnitine mobile phase KH2PO4 0.05M/CH3CN 60:40, inner salt (II) is reacted with a bromoacetic acid ester t - 25 C. flow rate: 1 ml/min (III) in an organic aprotic solvent, such as dimethyl detector R.I. mod 40 formamide, tetrahydrofurane or acetonitrile, at 20 capacity factor (K) calculated on the Br C.-40 C., for 2-24 hours. 25 anion peak, K = 0.94 The reaction product is precipitated with ethyl ether, filtered off and dried under vacuum. The bromide (IV) thus obtained is optionally con verted to X salt, by eluting the bromide through a Varian 300 MHz (CDCl3) 8 (p.p.m.): 1.43 (9H,s,C column of a strongly basic ion exchange resin such as 30 (CH3)3); AMBERLITE IRA 402 activated in HCO3 form and 2.70–2.94 (2H, m, CH2COO); 3.49 (9H,s,+N(CH3)3); adding the stoichiometric amount of the pharmacologi 3.66-3.87 (2H,m,CH2N); 4.52 (2H, sist. AB, OCH cally acceptable acid HX to the eluate aqueous solution, 2COO); or by eluting the bromide through a column of a 4.78 (H.m,CHOH). strongly basic ion exchange resin such as IRA 402 acti-3s EXAMPLE 2. vated in X form. Preparation of the ester of acetyl L-carnitine bromide In either case, the solid product, salified with X, is with tert-butyl glycolate (ST 766). obtained by lyophilization. The title compound was prepared as described in If the inner salts of the formula (I) are desired, the Example 1, utilizing acetyl L-carnitine inner salt. suitable tert-butyl ester, e.g. the compound of Example 40 Pysico-chemical properties. 1 (ST 777), is kept under stirring in trifiuoroacetic acid M.P.s 131-133 C. or in a mixture of trifiuoroacetic acid and methylene a25D= - 16,8 (C-1 in H2O) chloride at room temperature for one hour or in a 30% TLC: as in Example 1 solution of anhydrous hydrobromic acid in acetic acid.
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