It is generally observed that during dissolution of stability samples of hard gelatin capsules, pellicle are formed which decreases the dissolution. In such cases USP recommend the use of Pepsin/ Pancreatin. So i would like to know:
While performing dissolution for the hard gelatin capsules with Pepsin/ Pancreatin,
Should I set the pH of the buffer [for eg. pH 4.5] and then add Pepsin/ Pancreatin.
or
Should I add Pepsin/ Pancreatin to the media and then set the required pH [pH 4.5]?
Thanks/ Regards
The enzymes you mentioned are proteolytic enzymes and they are sensitive to pH ranges. Its a better way to set pH of buffer and add the enzyme.
When you add ENZYME and set pH , due to sensitivity of enzyme there is every possibility that it might get denatured or precipitate when it comes it its Isolectric pH.
Dear Sir,
Thanx for your reply.
USP says, in case of hard gelatin capsules, if dissolution fails due to the cross linkage of the gelatin, dissolution can be performed again in the same media specified in the monograph by adding enzyme. I the pH of media is 6.8 then pepsin should be used and if the ph of media is more than 6.8 pancreatin should be used.
Our media pH is less than 6.8. So we are preparing the media setting the desired ph and when adding Pepsin the pH decreases by about 1 unit.
Regards