Mantaining the Physical Properties of Pharmaceutical Oil

Some sort of chemical or biological activity is taking place within the oil that causes it to lose its physical properties within a few days. Try reducing the temperature and keeping it cool until it is needed for use, perhaps?

Thanks again for your prompt reply.

i wud try at low temperature & then discuss. but could you suggest me about the compulsory lab tests required to commercialize the product.

What country are you thinking of marketing this in?

in INDIA. pls suggest

Does India have an equivalent to the Food & Drugs Administration in the USA, or the British Pharmacopeia?

yes equivalent to USFDA & EPA (Environmental Protective)

Something like citric acid or potassium benzoate? There are lots of food grade spoilage inhibiters out there.

Another suggestion - pasteurization and septic packaging. Homogenization to keep its viscosity.

Tincture of benzoin is used as a preservative in natural products for skin applications. If you search "tincture of benzoin preservative" you'll find lots of discussion about home made cosmetics and the like. Check out this selection of preservatives sold for the purpose in Aussie.

Re: viscosity for til based oil: it sounds to me that you are looking for the way to prepare a stable emulsion.

You might also consider beeswax as an ingredient: I believe these harder 'ointment' type products are better keepers.

There are many good suggestions already posted. What pH are you trying to maintain? Citrate or phosphate buffers can keep pH from straying too far. If you are getting a foul odor after a few days, you have a "bug" problem- some sort of microbial activity (bacteria, mold, yeast, etc. ) Biological activity can also lower pH. You need to dose your formula with a biocide as the last step in manufacture. I've seen Kathon LX used in shampoos.If you are dispersing oil in water, you should homogenize it. You can vary the surfactant to affect viscosity.

A good source for obtaining information about common practices and processes used in a given field or industry is patents. Although most of a patent document is written in ambiguous legalese, there is a requirement to describe the materials and methods that can be used to realize an invention. Furthermore, it is common practice to describe all materials and methods that could possibly be used to achieve a given goal, as this ensures a broader legal coverage of the "invention", and prevents others from circumventing a patent by changing a few small details of the "invention". As a result, there is a great deal of information about common practices to achieve a given outcome in the patent literature. I suggest that you have a look at patents for some similar or related products for ideas.

As regards regulatory requirements, it would be a good idea to decide on the countries and markets that you wish to sell your product in, then look at the specific regulatory requirements that need to be followed in the chosen markets. Although most regulatory bodies have been working towards international harmonisation of regulatory procedures, the fact is that each country has slightly different requirements for gaining regulatory approval. A good start would be to look at the FDA and ISO (13485) requirements for pharmaceutical products, as these are the de facto standards used by most pharmaceutical companies.

As well as the suggestion of benzoate, perhaps some tea tree oil will help, both as part of the formulation and to help with relieving joint pain.

It is supposed to be both bactericidal and especially fungicidal.

Based on the limited data that you supply, whether the pH increases of decreases with time, etc, I would suspect that one or more C=C double bonds in the oil are being cleaved and oxidized to form an organic acid. You should also evaluate some good commercial anti-oxidants. You'll need detailed studies from a large group of people to foster clinical trials, which need to be done before you can get approval to market such a product. There are also a number of very effective commercial anti-microbial additives that you can screen quite rapidly and then complete a formal trial.

To control pH you need to identify buffer chemical in the form of liquid or solid soluble in the oil you have and maintains pH in the range you need to have

Viscosity change is clear indication your oil is if is one component system is breaking down and viscosity is decreasing. if is two parts component then there is reaction and degradation going on. You need to understand degradation mechanism and then put in place corrective action.

Most of natural occurring and oil and organic does get attack by fungus and that will change smell and performance with time and you need to identify anti fungus chemical and these are sensitive to what you want to protect.

I can name good many method and ways to control quality of the oil you have but never like to shot in dark. If you will let me know what and how much you need to establish control on quality of your oil I may be able to help you.

You can always contact me on email address Masyood@gmail.com or when I am visiting India we can meet. I have industry in Chennai and its Website is www.globalappliedmaterials.com and interested I can provide you my address during my visit there

When you mix almost any kind of oil and water you create a very nutritious mean for the bacteria to reproduce, thats well known to all machinists, who have to ad a bacteriostatic chemical to the cutting fluids and refrigerants, or else the odor is awful. Food processors are aware of this also.

Try Triclocarban or triclosan, both widely used in personal care products from soap to tooth paste.

Gluck !

This is attempt in the dark and not bad. There are more chemical but it is not worth of dicussion. Anti fungus you can find a list along with with some information good for what organic system. If you need you may go to www.Dow.com and you can find list or go to anther big chemical manufacturers like BASF and others