Very hygroscopic drug (e.g. Betahistine dihydrochloride) absorb moisture from atmosphere and difficult to handling like compression in tablet dosage form.
I want to do academic project on tablet dosage form using Betahistine dihydrochloride. What i do ?. Any solution is available?. Coating of api / coating of granules with moisture proof polymer before lubrication/ comprssion is effective to prevent hygroscopic problem with lesser possiblilities?.
Please tell what i do.
Using a direct compression method. Use direct compressible MCC as a diluent.
First check the moisture adsorption isotherm in DVS.
Find out the handling RH for the material. Let's say 30% RH. So you need an environment where 30%RH or less moisture is present to work with the API.
Then you can go for direct compression or dry granulation process in Roller compactor.
Check the blend flow and BD.If the BD is less and the blend has poor flow , suggest you to go for dry granulation.Use excipients which does not adsorb moisture or binds the moisture within them (look into COAs or speak with vendors/literature search)(Starch1500).Check in how many cycles you achieve 60-granules and 40-fines ratio.If it's more than 2, tweak the formulation.Hope this helps
Mix the drug with non hygroscopic excepients followed by direct compression so that its hygroscopic property can be reduced/avoided