I'll go into more detail later.
First, how many tablets do you take per day and which size are they? I'm not interested in your daily dosage, just the amount of polyethylene oxide that you are getting from your pills.
What are the chances Purdue switches back?
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I'll go into more detail later.
First, how many tablets do you take per day and which size are they? I'm not interested in your daily dosage, just the amount of polyethylene oxide that you are getting from your pills.
Just like I thought...Now can you ask your Doctor to test your urine for Oxalates?...If the results are positive I will tell you what is the problem and why this product is toxic.
Well if this medication is toxic would it not have to be pulled of the market by the FDA? I also have issues using the restroom. Start,stop,start,stop. My entire body and mental state has been getting worse each month i keep taking this medication. I tried others meds and had allergic reactions to all of them. The only thing getting me thru right now is my break through meds which is 30mg Ir's. A friend of mines Dr took him off his 80mg Oxy OP's and put him on 750 15mg IR's. Thats a lot of pills to take each day. Why doesn't Purdue just change back to the old formula until more studies are done? I agree with them trying to make a pill that is abuse proof but this formula is not the one. Just change back and do more studies and test on lab rats instead of the world of CPP's.
The reason I asked if you were less constipated has to do with the polyethylene oxide ingredient. It is one of two ingredients in the new pill that were not present in the old pill. (the other is an anti-oxidant, BHT, which has been safely used for many years as a food preservative, although some misinformed alarmists have recently been bad-mouthing it).
Polyethylene oxide (PEO) has some particular properties of interest. First the version used in oxycontin is HUGE, with a molecular weight on the order of about 6 million (in contrast, oxycodone has a molecular weight of 351.83). This molecule is much too large to be absorbed through the intestinal mucosa. It is, however, mucoadhesive, and can adhere to the intestinal mucosa. It may take many doses before this matters to a significant degree.
Another property of PEO is that it is highly hydrophilic, which means that it can absorb a great deal of water, producing a thick or thin gel depending upon the amount of water it absorbs. When there is a lot of water, as in the digestive tract, it becomes a thin gel that (with the aid of stomach muscle contractions) mixes thoroughly with the food you eat, which is called chyme when it enters the duodenum (the first part of the small intestine after the stomach).
Third, if you can think of oxycodone as a marble, PEO can be thought of as a block long length of wrapping paper that carries the "marble" along with itself. Before the oxycodone can be absorbed, it must be released from it's wrappings. This is accomplished by hydrating the PEO to produce a gel, and degradation of the PEO in the stomach, after which the oxycodone is free to diffuse through PEO gel (or rather, a mixture of PEO gel and other digestive contents)
Having mixed thoroughly with the chyme, PEO (along with it's trapped oxycodone) has already thoroughly mixed with the stool when it travels through the small and large intestines. The huge size of the molecules are what interfere with immediate absorption of the oxycodone. They form a maze within the chyme that oxycodone must wade through (aka diffuse through) to reach the intestinal mucosa. Some of the PEO may also adhere to the mucosa, to different degrees in different individuals. If a enough PEO adheres, the huge molecule size may make it difficult for the oxycodone to be absorbed at all. During the kind of testing that was done during the clinical trials¹, there was not sufficient time for enough PEO to adhere to the mucosa to affect absorption, but with repeated doses, absorption of oxycodone may be impaired. Absorption of other nutrients and drugs may be impaired as well. There may also be delay, as they must make their way through the same gel that regulates the oxycodone absorption rate.
The reason I asked how many tablets you take, and what size they were is that I suspect that the effect on the stools of the amount of water absorbed may be dependent upon the quantity of PEO that is taken².
It may be an oversimplification, but the less water you can absorb, the less you excrete.
If you are getting dehydrated because your stools are retaining water that you should be absorbing, your stools may be softer, you may have less urine output, your urine may be darker in color, and you may be constantly thirsty, no matter how much water you drink.
There are only two new ingredients, and neither are "toxic", as another poster implied. But there are other reasons that this drug should not be on the market. It was not properly tested. If any other company had brought this new formula to the FDA, they would have been made to undergo much more rigorous testing. They would have been required to have conducted Phase 1, Phase 2, and Phase 3 trials. They would have had to conduct double blinded studies. They would have had to use subjects who could benefit from the drug (as opposed to the opiate naive subjects used).
The FDA committee that voted to recommend approval did so, I believe, based on faulty evidence (see the clinical trials¹, for example). The committee's meeting minutes occupy 300 pages. The members explain their reasons for their votes starting on page 294. Four members, including the chairman voted "no", one abstained, and the remaining fourteen members voted yes. Some members said that they voted yes because, based on the data provided by Purdue, the new formula "appeared to be no worse" than the old formula. Only one member expressed concern over the "lack of clinical safety" data presented by Purdue.
Notes:
¹ In the clinical trials, subjects were given a single tablet. Their serum levels of oxycodone were measured for 72 hours and then extrapolated out to infinity. Obviously, this methodology could not evaluate the results of true repeated dosing. The trials were open label (as opposed to double blinded). All trial subjects were opiate naive. Although there is no mention of it, subjects receiving the highest dose (80mg) must have been given opiate antagonists, as well, because there were some subjects receiving that dose who experienced no adverse effects whatsoever (not even nausea or somnolence), despite being opiate naive. There were many other flaws in the trials, too many in fact to enumerate here.
² This effect may be compared to that of hydrophilic psyllium mucilloid (best known by the trade name Metamucil™).
Mr. Scientist you think you have all figured out, but you are leaving out a mayor issue, and that is that you are asumming that the PEO+OXY are just mixed. There is a process involved that you are not aware of....How do you think they make the OP to become hard?
No need to be facetious [, Mr. Spock!
]
I believe the point was that they are not "just mixed". The oxycodone is tightly bound because of properties involving the length of the huge PEO polymer. Think of an equivalent to the wrapping paper in his analogy actually wrapping around the "marble".
By curing the resin after dispersion of the oxycodone, of course! Do you have something else in mind? (besides the mayoralty race in your town) If so, please elaborate.
No need to be facetious [, Mr. Spock!
I believe the point was that they are not "just mixed". The oxycodone is tightly bound because of properties involving the length of the huge PEO polymer. Think of an equivalent to the wrapping paper in his analogy actually wrapping around the "marble". By curing the resin after dispersion of the oxycodone, of course! Do you have something else in mind? (besides the mayoralty race in your town) If so, please elaborate.
How do you think curing step is performed?, and what effects may have in the stability of the polymer PEO?
No need to be facetious [, Mr. Spock!
I believe the point was that they are not "just mixed". The oxycodone is tightly bound because of properties involving the length of the huge PEO polymer. Think of an equivalent to the wrapping paper in his analogy actually wrapping around the "marble". By curing the resin after dispersion of the oxycodone, of course! Do you have something else in mind? (besides the mayoralty race in your town) If so, please elaborate.
I don't know what the correct response should have been, but this one was not accurate. PolyOx (the PEO resin used in oxycontin) comes pre-cured.
Mixing of ingredients is typically done using a Turbula shaker mixer, after which the (dry) powder is compressede with a rotary Piccola press. Tablet hardness is a function of compression strength.
What you both referred to as "wrapping paper and marbles" is described in PolyOx documentation like this: "An increased molecular weight leads to a greater degree of polymer chain entanglement and an increase in gel strength, which tends to decrease the rate of diffusion of the drug". Although it basically says the same thing, it is less visually exciting, and certainly (coming from the horse's mouth, so to speak) more accurate.
See Formulation of POLYOX™ ER Matrices for a Highly Soluble Active and other documentation on the Dow and Colorcon web sites.
Re: What are the chances Purdue switches back
ZERO CHANCE 'OC' IS COMING BACK. IF YOU DON'T LIKE IT...TAKE SOMETHING ELSE! 'OP' IS HERE TO STAY.
ZERO CHANCE 'OC' IS COMING BACK. IF YOU DON'T LIKE IT...TAKE SOMETHING ELSE! 'OP' IS HERE TO STAY.
Good! Cause i can't wait to cash in on Purdues stupid mistake and under study of CPP on high doses. I already have 4 medical conditions from taking OPs for 5 months and my lawyer is licking his chops. I am sure there are going to be many,many more. FDA scientists, its not your money so of course you would not care. But Purdues bank account will. Purdue and the FDA made it easy for the lawyers and did all the leg work for lawsuits with showing how they got this GREAT medication approved. Good luck to Purdue and everyone else. I guess the court systems will settle it out.
Would like to know what is really in these pills purdue and the fda are not telling everything they even say that on the fda web site at the meeting between them on oct. 21-22 -10 for fear that someone would know how to break it down quicker to abuse that is all they are worried about not how it is making sick they really need to help the real pain people and fix all of the side affects
Ask your pharmacist for the package insert that comes with the sealed bottles that he dispenses your medicine from. It contains the complete list of ingredients.
A basic summary is: they removed quite a few excipients, including the original release matrix material, ammonio methacrylate copolymer, and they added two excipients. The new matrix material, a high molecular weight polyethylene oxide is one of them, and the other is an anti-oxidant which is there to to r***** deterioration of the new matrix material by oxidation.