Omeprazole Efervescent Tablets Tablets
Manuacturing Directions 1. Core material : magnesium omeprazole, 12. !g" nonpareil cores, 12. !g" #$%ro&$prop$l met#$lcellulose, 1.' !g" (ater puri)e%, *+. !g. -uspension la$ering is perorme% in a ui%/be% apparatus.Magnesium omeprazole is spra$e% onto inert suger see%s 0non/pareil cores rom a (ater suspension containing t#e %issolve% bin%er. 2. -eparating la$er core material 0step 1, 2*.+ !g" #$%ro&$prop$l cellulose, 2.*+ !g" talc, .* !g" magnesium stearate, .* !g" (ater puri)e%, '. !g. T#e prepare% core material is coating la$ere% (it# a separating la$er in a ui%/be% apparatus (it# a #$%ro&$prop$l cellulose solution containing talc an% magnesium stearate. *. Enteric coating la$er pellets (it# t#e la$er 0step 2, 2. !g" met#acr$lic aci% copol$mer 0*3 suspension, *'.4 !g" triet#$l citrate, *.' !g" mono/ an% %igl$ceri%es 056, .+' !g" pol$sorbate ', .7 !g" (ater puri)e%, 22.7' !g. T#e enteric coating la$er consisting o met#acr$lic aci% copol$mer, mono/ an% %igl$ceri%es, triet#$lcitrate, an% pol$sorbate is spra$e% onto t#e pellets 0la$ere% (it# a separating la$er in a ui%/be% apparatus. apparatus. 8n t#e same t$pe o apparatus t#e enteric coating la$ere% pellets are coate% (it# #$%ro&$prop$l met#$lcellulose9Mg/stearate suspension. . Over/coating la$er enteric/coate% pellets 0step *, .4 !g" #$%ro&$prop$l met#$lcellulose, .+' !g" mgstearate, .2 !g" (ater puri)e%, 11.7 !g. T#e pellets covere% b$ an over/coating la$er are classi)e% b$ sieving. +. T#e obtaine% enteric coating la$ere% pellets are mi&e% (it# prepare% granules an% ot#er components as %escribe% belo( an% t#ereater compresse% to efevescent tablets. 7. ranulation 01 tablets: citric aci% an#$%rous, 7+ g" Mannitol %rie%, 2 g" riboavin, .1 g" pol$vin$lp$rroli%one ;/2+ 0<=< ;/2+, 7. g" EtO> 3 0(9v, g. 4. <=< ;/2+ is %issolve% in et#anol to give t#e granulating solution. 8n t#is solution riboavin is %isperse%. Citric aci% an% mannitol are mi&e% an% t#e li?ui% is a%%e% an% t#e mass urt#er mi&e%. T#en t#e mass is put on a tra$ an% %rie% in a %r$ing oven or appro&imatel$ 2 #ours at ++@C. T#e granulate is mille% to pass sieve 1. mm. '. A premi& consisting o t#e ollo(ing is prepare% b$ %r$ mi&ing in a mi&er: -o%ium carbonate an#$%rous, *7 g" so%ium %o%ec$l sulate, 1 g" so%ium stear$lumarate, 1 g" essence orange, 2. g" sacc#arine so%ium, 2. g" pol$vin$l p$rroli%one cross/lin!e%, 4 g" enteric/coate% pellets rom above, +.4 g. . 6inal mi&ing: ranulate rom above, '11.1 g, premi& rom above, 22.4 g, so%ium bicarbonate, +* g. T#e )nal mi&ing time is minutes. 1. Compression to tablets is %one on a tabletting mac#ine e?uippe% (it# punc#es giving 2/mm %iameter at tablets (it# bevelle% e%ges. Tablet (eig#t is 1'+ mg.
