Hi,we have an issue with stability of serratiopeptidase.It is quite stable in capsules,where as in tablets we face stability issues with in 3 months of manufacturing, even though overages added about 50%.someone let me know how to rectify it.
Please provide following information,
- Are these enteric coated tablets?
- What kind of polymers used for coating ?
- What is the granulation type (aqueous / non-aqueous) and which binder is used ?
- Stability at what temperature and humiduty conditions is poor?
- And what is the packaging material used?
- How much assay are you getting at the end of 3 months and any other degradation observed?
sir,we purchase the serratiopeptidase raw material in form of enteric coated granules.We manufacture 3 product with respect to serratiopeptidase.
Product 1:Film coated tablet containing combination of serratiopeptidase+famotidone+diclofenac potassium.
Product 2: Film coated tablet containing combination of serratiopeptidase+aceclofenac+paracetamol.
Product 3 : capsule containing combination of serratiopeptidase+amoxycillin trihydrate+lactic acid bacillus EC spores.
Film coating material used is insta moist shield.
serratiopeptidase is added in the lubrication step.
The products are stored in room temperature 25-27 C and at RH 72-80.
The tablets are packed in PVDC blister packing.
AT the end of 3 months the assay value is about 75 - 80%
Thanks for providing information about Serratiopeptidase formulation.
You may try enteric coated (OR Delayed release) tablets formulation (R&D batches) as follows,
Serratiopeptidase can be formulated using HPMC phthalate as enteric coating polymer in optimum concentrations to optimize delayed drug release profile and to target the drug release in the small intestine regions and good stability of tablets.
- Lactose and maize starch are dry mixed and granulated using starch paste in hot water containing Methyl & Propyl parabens Sodium salts.
- Wet granules are screened and dried at around 65 deg C in FBD
- Add Mgnesium stearate, Maize starch as lubricants and Serratiopeptidase raw material. Mix and lubricate.
- Compress lubricated granules into tablets using standard concave upper & lower punches.
- Do enteric coating using first subcoating of HPMC polymer (15 cps), Propylene glycol & Methylene chloride solvent.
- Do enteric coating using HPMC Phthalate, Cetyl alcohol, Diethyl phthalate, and Acetone, IPA as solvents, and colourant (Iron Oxide & Titanium Oxide or any other). Perform coating and drying the tablets at around 55- 60 deg C in concentional coating pan.
- Packing of tablets can be done in PVDC blisters.