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Current Trends in Biotechnology and PharmacyVol. 5 (2) 1173-1182 April 2011. ISSN 0973-8916 (Print), 2230-7303 (Online)1181Fig 4. Formulations LE4 and LP3 showedmaximum drug permeation among their series.The patches LE1, LE2, LE3, LE4 LP2, LP3 andLP4 could meet the target flux (12.16 µg cm -2h -1 ). However, the formulations showed higherlag times except formulation LE4. Therefore thepatches LE4 (2282.3 µg) and LP3 (2765.7 µg)were considered to be optimum formulations. Inex vivo permeation studies, the permeationpattern is similar to in vitro release pattern. Theresults revealed that LCDP was released fromthe formulation and permeated through ratabdominal skin and hence could possibly permeatethrough the human skin. The permeation profileswere found follow higuchi kinetics as it wasevidenced from correlation coefficients (0.976-0.996)FTIR studies: The FTIR spectral analysis ofLCDP alone showed that the principal peakswere observed at wave numbers of 3349.8,2974.9, 1702, 1675.4, 1496.4 and 1310.8. In thespectra of the physical mixture of LCDP, ERLand PVP were 3349.7, 2979.5, 1702.6, 1675.7,1498, and 1311.3; 3349.4, 2974.5, 1675.8, 1497.9and 1311.3 wave numbers were observed for themixture of LCDP, ethyl cellulose and PVP.However, some additional peaks were observedwith physical mixtures, which could be due to thepresence of polymers. These results suggest thatthere is no interaction between the drug andpolymers used in the study. The polymers usedare in controlled/sustained release matrix typepatches because of their compatibility with anumber of drugs (19).Stability study: The stability of the optimizedformulations (LE4 and LP5) was investigated asper ICH guidelines. On storing the TDDS at atemperature of 40±2 °C/75±5 % RH for 6 months,1.52 % (LE4) and 1.89 % (LP3) degradation wasobserved. As the degradation is less than 5 % inthe formulation, a shelf life of 2 years could beassigned.ConclusionsMatrix type transdermal therapeuticsystems of lacidipine could be prepared with therequired flux having suitable mechanicalproperties. Further work is recommended insupport of its efficacy claims by long termpharmacokinetic and pharmacodynamic studiesin human beings.AcknowledgementsOne of the authors (Ramesh Gannu) thankAICTE, New Delhi, India for providing financialassistance in the form of National DoctoralFellowship (NDF).References1. Chien, Y. W. (1987). TransdermalTherapeutic System. In Controlled DrugDelivery Fundamentals and Applications,2nd ed.; Robinson, J R., Lee, V H, Eds.;New York: Marcel Dekker, 1987; pp 524–552.2. Kanikannan, N., Andega, S., Burton, S.,Babu, R.J. and Singh, M. (2004).Formulation and in vitro evaluation oftransdermal patches of melatonin. DrugDev. Ind. Pharm. 30: 205-212.3. Lee, C.R and Bryson, H.M. (1994).Lacidipine: a review of its pharmacodynamicand pharmacokinetic properties andtherapeutic potential in the treatment ofhypertension. Drugs 48: 274-2964. Mc Cormack, P.L and Wagstaff, A.J.(2003). Lacidipine a review of its use in themanagement of hypertension, Drugs 63:2327-23565. Mukherjee B, Mahapatra S, Gupta R, PatraB, Tiwari A and Arora P. (2005). Acomparison between povidone-ethylcellulose and povidone-eudragit transdermaldexamethasone matrix patches based on inDevelopment of matrix type transdermal patches of lacidipine
Current Trends in Biotechnology and PharmacyVol. 5 (2) 1173-1182 April 2011. ISSN 0973-8916 (Print), 2230-7303 (Online)1182vitro skin permeation. Eu J Pharm Biopharm59: 475-483.6. Ramesh, G., Chinna, R.P., Vamshi, V.Y.,Shravan, K.Y and Madhusudan, R.Y.(2010). Enhanced bioavailability oflacidipine via microemulsion basedtransdermal gels: formulation optimization,ex vivo and in vivo characterization. Int JPharm 388: 231-2417. Ramesh, G., Vamshi, V.Y., Chinna, R.P.,Shravan, K.Y and Madhusudan, R.Y.(2009). Development of high performanceliquid chromatography method for lacidipinein rabbit serum: application topharmacokinetic study. Anal Chim Acta632: 278–2838. Costa, P. and Lobo, SJM. (2001). Modelingand comparison of dissolution profiles. EurJ Pharm Sci 13:123-1339. Kusum, D.V., Saisivam, S., Maria, G.R andDeepti, P.U. (2003). Design and evaluationof matrix diffusion controlled transdermalpatches of verapamil hydrochloride. DrugDev. Ind. Pharm. 29: 495–50310. Korsmeyer, R.W., Gurny, R., Doelker, E.,Buri, P. and Peppas, N. A. (1983).Mechanism of solute release from poroushydro-matrices and other factors may beresponsible. Int. J. Pharm. 15: 25–3511. Gupta, R. and Mukarjee, B. (2003).Development and invitro evaluation ofdiltiazem hydrochloride transdermal patchesbased on povidone-ethyl cellulose matrices.Drug Dev. Ind. Pharm 29 (1): 1-712. Levang, A.K., Zhao, K and Singh, J. (1999).Effect of ethanol/propylene glycol on the invitro percutaneous absorption of aspirin,biophysical changes and macroscopic barrierproperties of the skin. Int J Pharm.181: 255-26313. Hayton, W.L and Chen, T. (1982).Correction of perfusate concentration forsample removal. J Pharm Sci. 71: 820 – 82114. Clarke’s Analysis of Drugs and Poisons(2007) www. medicinescomlete.com.15. ICH stability guidelines (No. QIA) (R2).Federal Register 2003, 68 (225), 65717.16. Mutalic, S and Udupa, N. (2004).Glibenclamide transdermal patches:physicochemical, pharmacodynamic andPharmacokinetic evaluation. J. Pharm. Sci.93(6): 1577-1594.17. Arora, P. and Mukherjee, B. (2002). Design,development, physicochemical, in vitro andin vivo evaluation of transdermal patchescontaining diclofenac diethyl ammonium salt.J Pharm Sci, 91: 2076-2089.18. Aulton, M.E., Abdul-Razzak, M.H. andHogan, J.E. (1981). The mechanicalproperties of hydroxypropyl methylcellulosefilms derived from aqueous systems: theinfluence of solid inclusions. Drug Dev. Ind.Pharm. 7: 649–668.19. Raymond, CR., Paul, JS and Marian, EQ.(2009). Hand book of pharmaceuticalexcipients. Washinton, DC: PharmaceuticalPress and American PharmacistsAssociation., 262-267, 525-533 and 581-585Ramesh Gannu et al
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