Stability Studies on Liquid preparation.

[Guest guest]

In the 3rd edition of the Trissel's Stability of Compounded Formulations, pg. 304, there is reference to a stability study done on 1mg/ml and 5mg/ml in a glycol/aqu. compounded. "Stability indicating HPLC analysis found less than 10% loss within 90 days at either 4 or 25 degrees C; most samples exhibited no loss." It must be noted that this was a solution that had been acidified by ascorbic acid and preserved with sodium benzoate. It is not, I repeat NOT a simple solution of tablets in water.

The consensus among compounders is that the simple solution should have an expiration date of less than or equal to 30 days. The problem here is that no one knows for sure. We use a 30 day dating on the simple solution and a 60 day date on the properly made solution.

DR. Skip

[Guest guest]

Excellent! I love reading science data. I used to acidify some of my standards to keep the bugs from growing in there. Sodiume benzoate is also a good preservative. We used a drop of concentrated HCl (37%) per either 100mL or 1L. This would give us a pH of about 2. Can't remember which right now. Our 2 week shelf life standards were used to make calibration curves, so we wouldn't put up with much degradation. It's possible our expiration dates are a little conservative for the rest of the world. I'm not qualified, especially without hard data, to make the call on physiological impact of 4 weeks vs. 2 week shelf lives. __________________________________________________

[Guest guest]

Hi Dr Skip, I was wondering whether you could advice me? My name is McGuinness, I live in the UK and I have what appears to be Primary Progressive MS. I have been on LDN for 9 months now. I get it in liquid form from a natural pharmacist in Wales. Initially I reacted well to the LDN getting better fatigue levels and bladder function. But over the last few months I feel I have been deteriating and I am wondering if It could be anything to do with the way I am taking the LDN? There is no use by date on the bottle so I do not know how long it has been prepared for and I also do not know whether it is made from Naltrexonne powder or crushed tablets. From your experience with LDN what is the best way to take it? Please could you advice me. Best wishes and thankyou for all your support with LDN

McGuinness slenzrph@... wrote: In the 3rd edition of the Trissel's Stability of Compounded Formulations, pg. 304, there is reference to a stability study done on 1mg/ml and 5mg/ml in a glycol/aqu. compounded. "Stability indicating HPLC analysis found less than 10% loss within 90 days at either 4 or 25 degrees C; most samples exhibited no loss." It must be noted that this

was a solution that had been acidified by ascorbic acid and preserved with sodium benzoate. It is not, I repeat NOT a simple solution of tablets in water. The consensus among compounders is that the simple solution should have an expiration date of less than or equal to 30 days. The problem here is that no one knows for sure. We use a 30 day dating on the simple solution and a 60 day date on the properly made solution. DR. Skip Send instant messages to your online friends http://uk.messenger.

[Guest guest]

In a message dated 6/14/2006 5:17:21 PM Eastern Daylight Time, sa_mcguinness@... writes:

I would not use anything without an expiry date. You might call your pharmacist and forward my email about the dating to him/her.

We only use the powder.

The easiet way for you to take it is the best. Naltrexone can be compounded into a capsule, a liquid and a transdermal.

There is no use by date on the bottle so I do not know how long it has been prepared for and I also do not know whether it is made from Naltrexonne powder or crushed tablets. From your experience with LDN what is the best way to take it?

Please could you advice me.

Best wishes and thankyou for all your support with LDN

McGuinness

[Guest guest]

sarah mcguinness <sa_mcguinness@...> wrote:

> There is no use by date on the bottle so I do not know how long it

has been prepared for and I also do not know whether it is made from

Naltrexonne powder or crushed tablets. From your experience with LDN

what is the best way to take it?

>

Dear

I wouldnt take it at all if I were you if the pharmacist who has

prepared it has failed to put a use by and/or expiry date on it. It

should never have been issued.

I live and work on the Isle of Wight, but I used to own and run two

large NHS GP practices employing 15 GPs at one time.

I was heavily involved in medicines management and have friends and

colleagues who are pharmacists.

To issue drugs in this manner would be considered to be at the very

least an error on the part of the pharmacist involved and at worst,

negligent.

I would check out their credentials and registration.

How do you know whats in the bottle?

Labels should be typed, with clear instructions on when, and how to

take your medication.

There should be a use by date and an issue date.

There should also be your name on the bottle and the address of the

issuing pharmacy.

Please be wary that what you have been given matches what you have

been prescribed by your doctor.

I think you should return the bottle to the pharmacy and point out

your concerns, so that if it is a simple oversight on the part of the

pharmacy they have the oportunity to correct it, and if not, you have

the knowledge now to realise they may be " dodgy " and go elsewhere.