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Wo 2011/060945 A2 (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 26 May 2011 (26.05.2011) WO 201 1/060945 A2 (51) International Patent Classification: (72) Inventor; and A61K 9/16 (2006.01) A61K 9/50 (2006.01) (75) Inventor/Applicant (for US only): PARENTE DUENA, A61K 9/48 (2006.01) A61K 31/403 (2006.01) Antonio [ES/ES]; Passeig Can Sagrera 17-21, E-08960 San Just Desvern - Barcelona (ES). (21) International Application Number: PCT/EP20 10/007025 (74) Agent: CARVAJAL Y URQUIJO, Isabel; Clarke, Mod- et & Co., C/Goya 11, E-28001 Madrid (ES). (22) International Filing Date: 19 November 2010 (19.1 1.2010) (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, English (25) Filing Language: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (26) Publication Langi English CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (30) Priority Data: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 200931024 20 November 2009 (20.1 1.2009) ES KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (71) Applicants (for all designated States except US): GP ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, PHARM, S.A. [ES/ES]; Poligono Industrial Els Vinyets - NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, Els Fogars, Ctra. Comarcal 244, km. 22, 08777 Sant SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, Quinti de Mediona, Barcelona (ES). DEFIANTE FAR- TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. MACEUTICA, S.A. [PT/PT]; Rua dos Ferreiros, 260, (84) Designated States (unless otherwise indicated, for every Funchal - Madeira, 9000 082 (PT). kind of regional protection available): ARIPO (BW, GH, (71) Applicants (for US only): SINGROSSI, Maria, Gabriel- GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, la (heiress of the deceased inventor) [ΓΓ/ΙΤ]; Via Agnello, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 19, 1-20121 Milan (IT). CARMINATI, Silvia (heiress of EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, the deceased inventor) [IT/IT]; Via Guido d'Arezzo, 11, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Milan (ΓΓ). CARMINATI, Giuseppe, Paolo (heir of the SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, deceased inventor) [ΓΓ/ΙΤ]; Via Pacini, 24, Milan (IT). GW, ML, MR, NE, SN, TD, TG). (72) Inventor: CARMINATI, Paolo (deceased). Published: — without international search report and to be republished upon receipt of that report (Rule 48.2(g)) < © o o (54) Title: CAPSULES OF ACTIVE PHARMACEUTICAL INGREDIENTS AND POLYUNSATURATED FATTY ACID E S TERS FOR THE TREATMENT OF CARDIOVASCULAR DISEASES (57) Abstract: Pharmaceutical composition in the form of a capsule which contains polyunsaturated fatty acid alkyl esters (PUFA) and active pharmaceutical ingredients for the treatment and/or prevention of cardiovascular diseases. CAPSULES OF ACTIVE PHARMACEUTICAL INGREDIENTS AND POLYUNSATURATED FATTY ACID ESTERS FOR THE TREATMENT OF CARDIOVASCULAR DISEASES FIELD OF THE INVENTION This invention relates to a pharmaceutical composition in the form of a capsule which comprises a suspension of polymeric microcapsules suspended in an oil which contains polyunsaturated fatty acid alkyl esters (PUFA), wherein the microcapsules contain at least one polymer and one active pharmaceutical ingredient, and its use for the treatment and/or prevention of cardiovascular diseases. BACKGROUND OF THE INVENTION Among the most used active pharmaceutical ingredients for the treatment of cardiovascular diseases, in particular for the treatment of hypertension, there are the angiotensin-converting enzyme inhibitors (ACE inhibitors) and the angiotensin II receptor blockers (ARB, angiotensin II receptor antagonists). ACE inhibitors and ARBs act on the renin-angiotensin system. ACE inhibitors inhibit the angiotensin-converting enzyme, preventing the conversion of angiotensin I to angiotensin II. They are very effective anti-hypertensive agents which are also used for the treatment of heart failure and myocardial infarction. The majority of ACE inhibitors are administered with the carboxyl group in alpha position with regards to the secondary amino group in the form of diethyl ester, although its acids are the biologically active form. The ARBs act by blocking the angiotensin II receptor in the arteries, preventing its action. Therefore, the ARBs are also a first-line treatment for hypertension, particularly in the case of patients who develop cough due to ACE inhibitors. ARBs are also used for the treatment of heart failure and diabetic nephropathy. Polyunsaturated fatty acids (PUFA) also possess a known beneficial effect on the prevention of cardiovascular events and are often used in combination therapy in patients who have suffered some type of cardiovascular episode. There are numerous studies on anti-hypertensive, reduction of serum cholesterol, anti-hypertriglyceridemic, antiarrhythmic, antiplatelet and anti-inflammatory effects of PUFAs [Bucher H.C. et al. Am. J. Med. 112: 298-304 (2002); Benatti P. et al. J. Am. Coll. Nutr. 23: 281-302 (2004); Lee J.H. et al. Mayo Clin. Proc. 83: 324-332 (2008); Heinz R. Adv. Ther. 26: 675-690 (2009)]. PUFAs are essential fatty acids and should be obtained from a person's diet. They are divided into omega-3 and omega-6 fatty acids depending on the position of the first unsaturation (n-3 and -6 respectively). The principal omega-3 fatty acids are found in fish oils, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). PUFAs can be found in the form of triglycerides or alkyl esters. Commercial compositions of omega-3 fatty acid alkyl esters vary in purity and content of fatty acids and are normally expressed in relation to the content in EPA and DHA. PUFAs, in any of their forms, are easily oxidized and should be stored under an inert atmosphere and protected from light. Commercial compositions contain antioxidants to minimize their degradation. The great instability of the aforementioned pharmaceutical antihypertensive active ingredients is also known, particularly of the ACE inhibitors. ACE inhibitors can suffer from three types of degradation: a) internal cyclization to form diketopiperazines, b) hydrolysis of the ester group of the side chain to give the diacid, and c) oxidation that produces unwanted colored products. Degradation occurs both in liquid and solid state. According to WO 2006/050533 A2, EP 0317878 B 1, US 5442008 A , US 5151433 A , WO 2004/064809 A 1 and EP 1429748 B 1, the instability of the known formulations of ramipril is influenced by different factors, such as mechanical stress (compression), the manufacturing process, excipients, storage conditions, heat and moisture. As a consequence, ramipril needs very controlled formulation conditions to minimize the decomposition and avoid the formation of the aforementioned degradation products (diketopiperazine and diacid). According to WO 2008/000040 A 1 and WO 2008/001 184 A2, the choice of the different excipients can affect the stability of ramipril and other ACE inhibitors such as quinapril, enalapril or spirapril, accelerating their degradation; furthermore, a significant cause of decomposition is mechanical stress associated with the manufacturing process. According to US 2007281000 A 1, to improve the stability of the active pharmaceutical ingredients sensitive to moisture, water scavenger compounds can be incorporated in the formulation, such as copovidone in the case of cilazapril. Fosinopril is unstable since it is susceptible to hydrolytic degradation in the ester and phosphodiester groups, and the same occurs with the trandolapril ester group; in EP 1906931 B 1 the compositions of these two active ingredients are stabilized with dimethicone, so that cyclization, hydrolysis and/or oxidation are inhibited. There are numerous examples in the literature which confirm that different ACE inhibitors decompose during the formulation of the active pharmaceutical ingredient, even during the process of preparation of the tablet. This problem is attempted to be solved, for example, by adding acid stabilizers [EP 0264888 B 1; EP 0468929 B 1; US 4830853 A], the formation of enalapril salts [WO 01/32689], with meglumine [WO 2005/041940 A1], by mixing the ACE inhibitor with a metal dispersion in alcohol [WO 04/071526 A1], through the use of alkali carbonates or alkaline earth metals to inhibit the cyclization or changes in color and a saccharide to inhibit hydrolysis [US 4743450 A], or with magnesium oxide as a stabilizer against the cyclization and means of moisture control [EP 1083931 B 1; WO 2008/000040 A1]. The approaches to the stabilization of pharmaceutical compositions which contain ACE inhibitors that do not use the addition of stabilizing excipients would be those which use polymer coatings, such as polymer coatings of agglomerate [US 5151433 A] or of individual particles of ramipril in the final solid formulation [WO 2006/050533 A2], or coating an inert nucleus with the active ingredient itself [US 2005202081 A1] that would avoid degradation induced both by the mechanical stress of compression and the contact of the active ingredient with potentially incompatible excipients. Some ARBs also show formulation problems, it being necessary to avoid the presence of water according to that deduced from the formulations described in the literature for valsartan [EP 1674080 A1]. Irbesartan, valsartan (both bulky powders) and candesartan cilexetil (sticky), for example, are very difficult to formulate in tablets or capsules due to the physical properties of the solids [EP 0747050 B 1, EP 1774967 A 1, WO 2008/012372 A1]. Formulations as suspensions of the losartan potassium salt degrade in the presence of light, resulting in the destruction of the imidazole ring [Seburg R.A.
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