Formulation and Evaluation of Perindopril Sublingual Tablets
Formulation and Evaluation of Perindopril Sublingual Tablets
Formulation and Evaluation of Perindopril Sublingual Tablets
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International Journal <strong>of</strong> Research in Pharmaceutical <strong>and</strong> Biomedical Sciences ISSN: 2229-3701The prepared tablets in all formulations possessedgood mechanical strength with sufficient hardnessin the range <strong>of</strong> 3.6 to2.8 kg/sq.cm. The tablet meanthickness was almost uniform in all formulations.The thickness varies between 3.9 to 3.8 mm.The friability varies between 0.39 to 0.33 %. Thefriability values between 1% were an indication <strong>of</strong>good mechanical resistance <strong>of</strong> tablets.The drug content in all formulations (F1toF4) washighly uniform <strong>and</strong> in the range <strong>of</strong> 100.87 to 98.82%.The wetting time was found to be in the range <strong>of</strong>132 sec to 45 sec. The water absorption ratio in allformulations (F1toF4) was found to be in the range<strong>of</strong> 55 to 27.It was observed that wetting time <strong>and</strong>water absorption ratio increased as theconcentration <strong>of</strong> crospovidone increased. Thedisintegration time in all formulations wereobserved within fraction <strong>of</strong> second. Thedisintegration time in all formulations (F1toF4) wasfound to be in the range 237 sec to 98 sec. It wasobserved that concentration <strong>of</strong> crospovidoneincreases disintegration time not decreasedsignificantly but the formulation F4, containg 8%crospovidone as superdisintegrant showed fasterdisintegration rate as compared to otherformulations.The in-vitro dissolution studies <strong>of</strong> all formulations(F1toF4) were conducted <strong>and</strong> the results are shownin table 03.The percentage <strong>of</strong> drug release forformulation, F1 was found to be 14.88 % during2min. And maximum percentage <strong>of</strong> drug releasewas found to be 97.01% during 26 min. Thepercentage <strong>of</strong> drug release for formulation, F2 wasfound to be 20.52 % during 2min. And maximumpercentage <strong>of</strong> drug release was found to be 98.51%during 22 min. The percentage <strong>of</strong> drug release forformulation, F3 was found to be 23.13 % during2min. And maximum percentage <strong>of</strong> drug releasewas found to be 97.76 % during 26 min. Thepercentage <strong>of</strong> drug release for formulation, F4 wasfound to be 35.51% during 2min. And maximumpercentage <strong>of</strong> drug release was found to be 99.88 %during12 min .From the above studies, it wasobserved that increase in concentration <strong>of</strong>superdisintegrant i.e. crospovidone, the percentage<strong>of</strong> drug release increased. Among the allformulations (F1toF4) , the best in-vitro drugrelease observed in formulation ,F4 was found tobe 99.88 %, as increase the concentration <strong>of</strong>crospovidone that is due to result <strong>of</strong> rapiddisintegration. During the dissolution studies, itwas observed that the tablets were initially swelled<strong>and</strong> erodible over period <strong>of</strong> time.The in-vitro drug release data <strong>of</strong> all <strong>Perindopril</strong>sublingual tablets were subjected to goodness <strong>of</strong> fittest by linear regression analysis according to Zeroorder equation, Ist order equation, Higuchi’sequation <strong>and</strong> Krosmeyer-Peppas equation toascertain the mechanism <strong>of</strong> drug release. Theresults <strong>of</strong> linear regression analysis includingregression coefficient are presented in table04.Among the regression correlation co-efficient(R 2 ) values <strong>of</strong> Ist order equation was found to behigher, similarly among the Higuchi’s equation <strong>and</strong>Krosmeyer-Peppas equation, the (R 2 ) values <strong>of</strong>Higuchi’s equation was found to be higher .Hencethe drug release followed the Ist order releasekinetics with diffusion mechanism.Table 1: <strong>Formulation</strong> Composition <strong>of</strong> Fast Dissolving<strong>Sublingual</strong> <strong>Tablets</strong> <strong>of</strong> <strong>Perindopril</strong>Ingredients F1 F2 F3 F4<strong>Perindopril</strong> 4 4 4 4Crospovidone 4 8 12 16Sodium saccharine 10 10 10 10Mannitol 85 85 85 85Micro crystalline cellulose 91 87 83 79Talc 3 3 3 3Magnesium stearate 3 3 3 3Table 2: Weight variation, Hardness, Thickness <strong>and</strong>Friability <strong>of</strong> <strong>Perindopril</strong> sublingual tablets<strong>Formulation</strong> codeWeightVariationHardness(kg/cm 2 )Thickness(mm)Friability(% )F1 202.15 3.1 3.9 0.29F2 200.18 2.8 3.7 0.33F3 201.86 3.5 3.8 0.35F4 199.98 3.5 3.8 0.321196Vol. 2 (3) Jul – Sep 2011www.ijrpbsonline.com