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United States Patent (19) 20 United States Patent (19) 11 Patent Number: 5,043,165 Radhakrishnan (45) Date of Patent: "Aug. 27, 1991 (54) NOVELLIPOSOME COMPOSITION FOR (56) References Cited SUSTANED RELEASE OF STEROIDAL U.S. PATENT DOCUMENTS DRUGS 4,224,179 9/1980 Schneider ........................... 424/450 4,235,871 11/1980 Parahadjopoulos et al........ 424/450 (75) Inventor: Ramachandran Radhakrishnan, 4,515,736 5/1985 Deaner ................................... 424/9 Fremont, Calif. 4,693,999 9/1987 Axelsson et al. .................... 514/18O 4,746,516 5/1988 Moro et al. ........................... 514/36 73 Assignee: Liposome Technology, Inc., Menlo 4,780,455 10/1988 Lieberman et al. ................. 514/82 Park, Calif. Primary Examiner-Thurman K. Page Assistant Examiner-P. L. Prater * Notice: The portion of the term of this patent Attorney, Agent, or Firm-Hana Dolezalova subsequent to Mar. 6, 2007 has been (57 ABSTRACT disclaimed. This invention relates to a novel, non-conventional liposome formulation for the sustained release and de 21 Appl. No.: 284,216 livery of steroids. The formulation provides prolonged release of the drug, improved therapeutic ratio, lower (22 Filed: Dec. 14, 1988 toxicity, reduced systemic side effects and is stable for up to three months. The formulation is suitable for sus 51) Int. Cl............................................... A61K 37/22 tained delivery of steroid via inhalation, parenteral, 52 U.S. C. ..................................... 424/450; 424/1.1; intrathecal, intraarticular, topical, ophthalmic, and oral 424/9; 514/180 administration. 58) Field of Search ............................ 424/450, 9, 1.1; 514/180 43 Claims, 7 Drawing Sheets 5O OO E 5O N s 20 L to s CO 5 C - OL 2 O O.5 O 5 2.O 2.5 HOURS U.S. Patent Aug. 27, 1991 Sheet 1 of 7 5,043,165 3 s e 8 OO OCN O O CN u/5u 39W WWSWild U.S. Patent Aug. 27, 1991 Sheet 2 of 7 5,043,165 OOO O O O O O 8 OOON CO O V NO CN 9 u/Bu'39W WWSWld U.S. Patent Aug. 27, 1991 Sheet 3 of 7 5,043,165 SEIWOSOCJITTVÅLITEN-NOLLVTILLSNI*LºlO—o SEIWOSOGITOINOINV-NOLLVTILLSNIºLºl•—• OOOO O O O O O O| O9| OOdo N. O LO V NO CN u/Bu '9W WWSW U.S. Patent Aug. 27, 1991 Sheet 4 of 7 5,043,165 to33 : e g 3 8 O u/6u'dO9-0 U.S. Patent Aug. 27, 1991 Sheet 5 of 7 5,043,165 09 OOO! OO! Ju/5u'dO8 SWALINILOWOIOvy WWSWild U.S. Patent Aug. 27, 1991 Sheet 6 of 7 5,043,165 FIG. 6 OOO O co Z D - 2 iO.O Z Z C > i.o O N R O. OO O.5 O 5 2.O 2.5 3.O HOURS BDP (mg/kg) Ty2Chr) CHSO4/CH/EPC/4C-BDP O-O O.OO7 . 2.4 3O/O/6O/ 2 a-a O. 87 O.68 53/37/O/9 V-V. O.26O O9 5O/4O/O/O o-O O.26O O89 55/4O/O/5 O-O O.O35 O.78 5O/4O/O/O O-O O.OO8 3.O CFREE BDP, i.v.) U.S. Patent Aug. 27, 1991 Sheet 7 of 7 5,043,165 (E.LV/WILSE%12)dC]8BBH-3–––– (E_1\/W?LSE%2.1)dC].8GBLVTITISdVONE· O| OOO! u/Bu'd09-0 5,043,165 1. 2 undesirable side effects accompanying steroid therapies NOVELLIPOSOME COMPOSITION FOR would be diminished. SUSTAINED RELEASE OF STEROIDAL DRUGS Some of the difficulties connected with steroid for mulation are due to the fact that steroids are poorly BACKGROUND OF THE INVENTION 5 soluble or insoluble in water. For that reason, Inethods 1. Field of the Invention previously used to obtain effective formulation have The present invention relates to a novel nonconven relied either on use of organic solvents or on crystalline tional liposome composition enabling an efficient load suspensions in an aqueous medium. Organic solvents such as ethanol, butanol, propanol and others are prone ing and sustained release of steroidal drugs. The compo O to cause tissue irritation and may be painful when ad sition is particularly useful in formulating steroids for ministered by certain routes. inhalation, targeted systemic, parenteral, oral, intrathe To avoid the severe systemic side effects, one of the cal, intraarticular, nasal, ophthalmic and topical admin commonly used preferred route of administration of istrations for human and veterinary therapeutic applica steroids for treatment of pulmonary conditions is via tions. 5 inhalation. However, the inhalation of normally formu 2. Related Disclosures lated steroids leads to a rapid absorption, introducing Steroids, in particular corticosteroids, have been the possibility of overdose or necessitating the more found to have a wide repertoire of therapeutic applica frequent dosing when lower doses are used, which in tions. For pharmaceutical use, these steroids are synthe turn, cause the heightening of systemic side effects. sized as structural analogues of the adrenocortical hor 20 Notwithstanding, even the normally formulated steroi mone hydrocortisone. Corticosteroids have powerful dal inhalants are preferable for replacing systemically effects on immunologic and hormonal processes, and administered steroids because they reduce, albeit not are very effective in treating a wide range of inflamma eliminate, the side effects when inhaled at recom tory diseases, such as arthritis, rheumatoid arthritis, mended doses. The need for repeated dosing however allergic reactions and conditions such as asthma, pulmo 25 remains. That need can only be avoided by providing nary fibrosis and other lung diseases, and are widely the formulation allowing for sustained controlled re used for treatment of ophthalmic and dermatological lease of the steroid. irritations. The advantage of inhalation administration of ste As with many potent drugs given systemically, the roids over the systemic administration can best be illus therapeutic benefits of corticosteroids are accompanied 30 trated using, for example, a potent antiinflammatory by an array of deleterious side effects, such as, among steroid dexamethasone. Dexamethasone is normally others, muscular atrophy, disruption of adrenal-pitui administered systemically by i.v. injection in doses tary axis resulting in stunted growth in children, edema, hypertension, osteoporosis, glaucoma, damage to the ranging from 0.5 to 9 mg/day with even higher doses 35 required in certain severe conditions. Where, however, immune system leading to susceptibility to viral and dexamethasone is administered via inhalation, the dose fungal infections, psychological disorders, and even is approximately 0.084 mg. The total dose of inhaled heart failure. dexanethasone daily, even when the inhalation is re Attempts to minimize these complications were not peated at the maximum dosing frequency, i.e. 12 times a very successful. For example, daily systemic adminis 40 day, corresponds to 0.4 to 0.6 mg to a maximum of tration of smaller, insufficient and inadequate doses of around 1.0 mg of absorbed dexamethasone a day. PDR: steroids for desired therapy led to unsuccessful or pro 1312 and 1315 (1988). That is a substantial decrease in longed treatments. On the other hand, an administration steroids' dose needed per day to achieve the same thera of the higher doses of steroids on alternate days led to peutic effect. uneven levels and peaks in the blood level of the steroid. 45 Beclomethasone, halogenated synthetic analog of High level peaks of steroid were followed by the side cortisol used in a form of beclomethasone dipropionate effects. Both, extended treatment and side effects, were (BDP) faces a similar problem. BDP is currently used found to be highly undesirable. for inhalation and as a nasal spray for treatment of bron Thus, it would be greatly advantageous to provide a chial asthma and seasonal and perennial rhinitis. Be pharmaceutical formulation which would allow slow 50 cause beclomethasone dipropionate is poorly soluble in but sustained release of steroids preferably only at the water, it is currently formulated as a microcrystalline target organ. suspension in halogenated alkane (Freon) propellants Some improvements were achieved by focusing on (PDR:1003 (1988). administration of steroids via routes that diminish the The secondary adverse reactions following the use of systemic side effects elsewhere in the body, or by for 55 these inhalers and sprays include localized infection of mulating them in delivery systems that might improve the mouth and pharynx with Candida albicans or Asper the benefit-to-toxicity therapeutic ratio. However, be gillus niger, hoarseness and dry mouth. Simultaneous cause of steroids' poor solubility in water, these at use of these steroids with other aerosols is not recom tempts to formulate steroids in an appropriate vehicles mended due to potential toxicity from the inhaled fluo for particular therapies have been, in general, unsuc rocarbon propellants. Further, tissue irritation has been cessful. reported due to drug crystallization and sedimentation Thus, it would be advantageous to have available a during storage. steroid composition formulated in such a way as to The advantages connected with using inhalation carry to and release in the particular organ in need of route rather than systemic administration are lessened such therapy an effective dose for extended periods of 65 by the necessity of multiple dosing. Such dosing is in time using the minimum amount of steroid. By solving convenient, unpleasant, and may lead to nasal or oral such formulation challenges, that is, by developing an mucosal tissue damage caused by repeated application appropriate formulation vehicle for each therapy, the of fluorocarbon, a drug carrying propeliant, or by a 5,043,165 3 4. solvent, or other additives necessary for nasal or oral pharmaceutical agents which improve the therapeutic inhalation administration. value of a wide variety of compounds. Thus, it would be highly desirable to have a steroid Liposome drug delivery Systems are reviewed in formulation in the form of an inhalation system provid detail in Cancer Res., 43:4730 (1983).
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