A preliminary pharmacokinetic study of liposomal leuprolide dry powder inhaler: A technical note
Tóm tắt
The developed liposomal DPI of LEU (LLEUn-DPI) demonstrated approximately 50% bioavailability compared with SC route. The studies justify the role of the pulmonary route as a promising alternative to the presently available SC route. The components of liposomal vesicles may be suitably changed to achieve higher bioavailability. Pulmonary delivery of LEU is expected to help in improving patient compliance, self-administration and avoiding the complications related to injection procedure. The developed LEU-DPI may be employed for both male and female contraception and treatment of prostate cancer in men and early puberty in children. In women it may be used for ovarian, endometrial, pancreas, and breast cancer; endometriosis; Uterine Leiomyoma; and anemia due to uterine fibroid tumors. However, the role of LEU-DPI in clinical practice can only be justified only after in vivo studies on 2 species of animals followed by extensive clinical trials.
Tài liệu tham khảo
Jiang G, Qiu W, Deluca PP. Preparation and in vitro/in vivo evaluation of insulin-loaded poly (acryloyl-hydroxyethyl starch)-PLGA composite microspheres.Pharm Res. 2003;20:452–459.
Hildebrand GE, Tack JW. Microencapsulation of peptides and proteins.Int J Pharm. 2000;196:173–176.
Haeckel S, Sachse S, Albayrak C, Müller RH. Preparation and characterization of insulin-loaded microcapsules produced by the induced phase separation method. In: Proceedings of the World Meeting, Association of Industrial Galenique Pharmacy/Association of Primate Veterinarians; May 25–28, 1998; Paris, France. 1998. 507–508.
Wall DA. Pulmonary absorption of peptides and proteins.Drug Deliv. 1995;2:1–20.
Stanley SD. Delivery of peptide and non-peptide drugs through the respiratory tract.Pharm Sci Tech Today. 1999;12:450–459.
Niven RW. Delivery of biotherapeutics by inhalation aerosol.Crit Rev Ther Drug Carrier Syst. 1995;12:151–231.
Patton JS, Trinchero P, Platz RM. Bioavailability of pulmonary delivered peptide and protein: interferon alpha, calcitonin and parathyroid hormones.J Control Release. 1994;28:79–85.
Edwards DA, Hanes J, Caponetti G, et al. Large porous particles for pulmonary drug delivery.Science. 1997;276:1868–1871.
Berelowitz M, Becker G. Inhaled insulin: clinical pharmacology and clinical study results.Respir Drug Deliv. 2000;7:151–154.
Clauson PG, Balent B, Okikawa J, et al. PK-PD of four different doses of pulmonary insulin delivered with AERx Diabetes management system.Respir Drug Deliv. 2000;7:155–161.
Adjei A, Hui J, Finley R, Lin T, Fort F. Pulmonary bioavailability of leuprolide acetate following multiple dosing to beagle dogs: some pharmacokinetic and pre-clinical issues.Int J Pharm. 1994;107:57–66.
Garber RA, Cappelleri JC, Kourides IA, Gelgend RA, Chandler LP, Gorkin L. Improved patient satisfaction with inhaled insulin in subjects with Type I diabetes mellitus: results from a multi-center randomized controlled trial.Diabetes. 1999;48:A13.
Ganderton D. Targeted delivery of inhaled drugs: current challenges and future trends.J Aerosol Med. 1999;12:3–8.
Saari M, Vidgren MT, Koskinen MO, Turjanmaa VMH, Nieminen MM. Pulmonary distribution and clearance of two beclomethasone liposome formulations in healthy volunteers.Int J Pharm. 1999;181:1–9.
Waldrep JC, Gilbert BE, Knight CM, et al. Pulmonary delivery of beclomethasone liposome aerosol in volunteers. Tolerance and safety.Chest. 1997;111:316–323.
Kimelberg HK, Mayhew EG. Properties and biological effects of liposomes and their uses in pharmacology and toxicology.CRC Crit Rev Toxicol. 1978;6:25–79.
Szoka F, Papahadjopoulos D. Liposomes: preparation and characterization. In: Knight CG, ed.Liposomes: From Physical Structure to Therapeutic Applications. New York, NY: Elsevier/North-Holland Biomedical Press; 1981:51–82.
Poznansky MJ, Juliano RL. Biological approaches to the controlled delivery of drugs: a critical review.Pharmacol Rev. 1984;36:277–336.
Knight CG.Liposomes: From Physical Structure to Therapeutic Applications. New York, NY: Elsevier/North-Holland Biomedical Press; 1981.
Akwete LA, Hsu L. Leuprolide and other LH-RH analogues in stability and characterization of protein and peptide drugs: case histories. In: Wang YJ, Pearlman R, eds.Formation, Characterization, and Stability of Protein Drugs. New York, NY: Plenum Press; 1993:159–199.
Enna SJ, Schanker LS. Absorption of drugs from the rat lung.Am J Physiol. 1972;223:1227–1231.
Poulain FR, Allen L, Williams MC, Hamilton RL, Hawgood S. Effects of surfactant apolipoproteins on liposome structure: implications for tubular myelin formation.Am J Physiol. 1992;262:L730-L739.