Formulation and Evaluation of Vaginal Suppositories Containing Lactobacillus

The objective of this study was to develop vaginal suppository containing lactobacillus. Four kinds of vaginal suppositories containing Lactobacillus paracasei HL32 were formulated: 1) a conventional suppository with Witepsol H-15 as a base, 2) a conventional suppository with mixed polyethylene glycols (PEGs) as a base, 3) a hollow-type suppository with Witepsol H-15 as a base and 4) a hollow-type suppository with mixed PEGs as a base. The release studies demonstrated that the hollow-type suppository with mixed PEGs as the base gave the highest release of L. paracasei HL32 and was microbiological stable after storage at 2- 8°C over the period of 3 months.




References:
[1] S. Uehara, K. Monden, K. Nomoto, Y. Seno, R. Kariyam, and H.
Kumon, "A pilot study evaluating the safety and effectiveness of
lactobacillus vaginal suppositories in patients with recurrent urinary tract
infectin," Int. J. Microbiol. Agent, vol. 285, pp. 530-534, 2006.
[2] F.M.E. Wagenlehner, and K.G. Naber, "Treatment of bacterial urinary
tract infections presence and future," Eur. Urol. vol. 49, pp. 235-244,
2006.
[3] G. Reid, "Potential prevents strategies and therapies in urinary tract
infection," World J. Urol., vol. 17, pp. 359-363, 1999.
[4] C.M. Slaver, "Lactobacillus: a Review," Clin. Microbiol. Newsletter,
vol. 30, pp. 23-27, 2008.
[5] Report of a joint FAO/WHO Expert consultation on health and
nutritional properties of probiotics in food including powder milk with
live lactic acid bacteria. American and Cordopa Park Hotel, Cordoba,
Argentina, 1-4 October 2001.
http://www.who.int/foodsafety/publications/fs_management
/en/probiotics.pdf.
[6] C. Dunne, L. O-Mahony, G. Thomton, G.M. Feeney, C. Daly, G.
O-Sullivan, and K. Collins, "In vitro selection criteria for probiotic
bacteria of human origin correlation with in vitro findings," Am. J. Clin.
Nutr., vol. 73, pp. 386-392, 2001.
[7] J. Lepargneur, and V. Rousseau, "Role protecteur de la flore de
Doderlein," J. Gynecol. Obstet. Biol. Reprod., vol. 31, pp. 485-494,
2002.
[8] G. Reid, and J. Burton, "Use of lactobacillus to prevent infection by
pathogenic bacteria," Microbes. Infect., vol. 4, pp. 319-324, 2002.
[9] A. Hallen, C. Jarstran, and C. Pahlson, "Treatment of bacterial vaginosis
with lactobacilli," Sex Transm. Dis., vol 19, pp. 146-148, 1992.
[10] Shalev, S. Battino, E. Weiner, R. Colodner, Y. Keness, "Ingestion of
yogurt containing Lactobacillus acidophilus compared with pasteurized
yogurt as prophylaxis for recurrent candidial vaginitis and bacterial
vaginosis," Arch. Farm. Med., vol. 5, pp. 593-596, 1996.
[11] V.V. Kale, R.V. Trivedi, and P. Sanjay, "Development and evaluation of
a suppository formulation containing lactobacillus and its application in
vaginal diseases," Ann. N.Y. Acad. Sci., vol. 1056, pp. 359-365, 2005.
[12] K. Pongsomboon, S. Kaewnopparat, T. Pitakpornpreecha, and T.
Srichana, "Antibacterial activity of a bacteriocin from Lactobacillus
paracasei HL32 against Porphyromonas gingivalis," Arch. Oral. Biol.,
vol. 51(9), pp. 784-93. 2006.
[13] Y. Watanabe, et. al., "Pharmaceutical evaluation of hollow type
suppositories. IV. Improvement of bioavailability of propranolol in
rabbits after rectal administration," J. Pharmacobiodyn., vol. 9. pp. 526-
531, 1986.
[14] Y. Watanabe, and M. Matsumoto, "Pharmaceutical evaluation of hollow
type suppository. I. Brilliant blue FCF release characteristics of
oleagenous hollow type suppository," Journal of the Pharmaceutical
Society of Japan, vol. 104(5), pp. 479-484, 1984.
[15] British Pharmacopoeia. London: The Stationary Office; 2001: p. 2015,
A235R.
[16] M. Tanaka, E. Kuwahara, M. Takahashi et al., "Enhanced rectal
absorption of amphotericin B lyophilized with glycyrrhizinate in
rabbits," Biol. Pharm. Bull., vol. 21, pp.853-857, 1998.
[17] E.A. Hosny, S.S. Abdeel-Hady, and K. El-Tahir, "Formulation, in vitro
release and ex vivo spasmolytic effects of mebeverine hydrochloride
suppositories containing polycarbophil or polysorbate 80," Int. J.
Pharm., vol. 142, pp.163-168, 1996.