Are there differences between Roche (Ro)Accutane and generic brands?

ok, so here is the lowdown. I read the article kindly sent to me by Olivia (Ton254) :) (cheers m’lovely) and have summarised the findings of a study comparing various aspects of some generic forms of isotretinoin (from 2006) and the original Roch pills. This study was funded by roche btw:

(if you stumbled here a-looking for my latest diary the check out my previous entry)

the generics studied were Accunetan,Accuran,Acnetane,Acne-Tretin,Acnil,Acnotin,Aknal,Cecnoin,Curatane,Dercutane,Isoface,Retinide,Scheritonin and Tretin

1. Isotretinoin content -Roche have a content tolerence of 5% so 95% and 105% of the stated content is acceptable, for example, a 10m tablet may contain 9.5mg or 10.5 mg and still make it into your pack. Almost all generics complied with this.

2. impurity and inactive ingredients: capsules contained soy oil, butylated hydroxyanisole (BHA),butylated hydroxytoluene (BHT), α-tocopherol,methylparaben, propylparaben, fatty-acyl esters and triglycerides. Roche maintains a less than 2.54% total impurities limit on their drugs. eight out of 14 generics exceeded this amount of impurities, including Tretinoin (trans retanoic acid = vitamin A)

3. shelf life – only those tablets stored in Roche-style aluminium blister packs retained their Isotretinoin contnt after 6 months storage.

4. particle size – there was a wide range of particle sizes between the different generics and roche. Those with smaller particles will be absorbed more easily, and those with larger particles less easily.

ok so how could this affect your treatment? well, the only two points of interest are the ‘unknown impurities’ which were discovered (who KNOWS what they are, but don’t be alarmed, there are impurities in all drugs) most importantly the particle size. So someone taking 50mg a day of a geneic brand with smaller particle size than Roche will be effectively receiving a higher dose than if they were taking 50mg of Roche Roaccutane, or any other generic with larger particles. There are comments made about the fact that the generics with larger particles tend to give less side effects, but this is intuitive if the patients are not absorbing as much of the drug. Of course this does not make them more or less likely to work, but would suggest that a longer treatment plan should be used when larger paricle generics are used, or higher doses to compensate. unfortunately the particle size form generics is not readily available so I guess the best indicator of the paricle size is how itchy your arms get, or how flaky your chin is :P

One last thing. Isotretinoin is fat soluble. it is very insoluble in water. To get the most out of  your treatment you should take the pills with some fatty food, or as I do, with an evening primrose oil tablet mid-meal, (followed by a chocolate muffin…but thats just cos Im greedy).

Dr. Sparkly Pickle x

so thats it folks. there ARE differences betwen brands,

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