Excipients proportion in solid dosage form

[Melisa_bd]

Hi everybody


Can anybody refer me
How percentage of lubricants i can use for a formulation
any guideline or link

Sincerely

[johnep]

Have you tried google magnesium stearate?
Took me all of two seconds to find this:
http://www.carterpharmaceuticalconsu...facturing.html

johnep

[Melisa_bd]

Thx jonep for the link
Sorry for the same question twice.

But still in problem
not very specific....like use of magnesium stearate or safe use % maximum, for extended release tablet, if there any regulatory problem?
Searched in google for couple of days....

Thx again

[johnep]

Well, you did not give sufficient information to start. Have you googled extended release tablets?. These are usually formulated as a wax matrix from which the active substance leaches out, or as a mixture of coated granules with different dissolution times. Easiest example would be an enteric coated tablet which has a delay factor built in as it dissolves in the small intestine. Compaction of the granules can cause problems which is why majority of slow release formulations are capsules. Why use magnesium stearate?
Excess mag stear would cause dissolution problems. Have you checked the safety data sheet for mag stear. It is a fairly expensive material. No one would use more than necessary. Cannot think of any toxicity problems so no % max needed other than in specs for specific tablets. What material are you trying to formulate into slow release?
johnep

[Fleegle]

Thx jonep for the link
Sorry for the same question twice.

But still in problem
not very specific....like use of magnesium stearate or safe use % maximum, for extended release tablet, if there any regulatory problem?
Searched in google for couple of days....

Thx again

Melisa_bd...

As you are in Bangladesh, if you are experiencing formulation problems, could you please let us know what excipients you have at your disposal, and we will do our best to advise.

Fleegle.

[Melisa_bd]

Thanks for the responses.......
Maybe I failed to explain my problem

I am trying with my exact problem
I was trying to develop an extended release tablet by hydrophobic polymer matrix, off course Magnesium stearate is their for lubrication.
When the stability data comes to me after six months, it passed with all good results
But I could not feeling good as Magnesium stearate is used 3.5% while it is generally used 0.5 - maximum 2%
My thought was going on if there any regulation like fda forbidden do not use magnesium NMT 2%.......

I was scared if i used magnesium stearate more than fda/uk-mhra guideline then definitely i have to increase/adjust polymer's proportion as magnesium stearate which also got some hydrophobic property & maybe affected the dissolution rate.

Anyway, hoping somebody will come forward to correct me

Sincererly

[johnep]

Did you use a range of % to establish that 3.5% was necessary?
Seem to remember that if tablet difficult at compression stage, may have to use a slugging machine.
johnep
.

[Melisa_bd]

There were no compression & in-process control problem

[johnep]

Found this article Lubrication Potential of Magnesium Stearate Studied on Instrumented Rotary Tablet Press
Will now check out FDA requirements in general. Could not find any.
http://www.raysahelian.com/magnesiumstearate.html
johnep

[johnep]

Which begs the question: Why use double the usual inclusion rate for Mag Stear?
Repeat with standard dosage.
johnep