Normast, Pelvilen, PeaPure: some differences and similarities

Normast, Pelvilen, PeaPure: we will discuss some differences and similarities of these three nutraceuticals. Palmitoylethanolamide is the active ingredient in all three. Normast is the Italian branded nutraceutical, available in Italy probably since 2007. Normast was developed since the end of last year, and the name Normast refers to the normalization of mast cell hyperactvity. The brandname Normast has been created in 2005. Normast is the brand name of the in Italy produced palmitoylethanolamide version, Pelvilen consists of 400 and 200 mg tablets, and PeaPure is a brand introduced in 2012 by the company Russell Science Ltd, produced in the Netherlands.  

Normast 300 mg, Normast 600 mg and Normast 600 mg Sachets

Normast is the brand name of the in Italy produced palmitoylethanolamide version, which comes in two different formulations. Normast 600 and 300 mg are matrix tablets, each containing slighly more than 60% palmitoylethanolamide in each tablet, the rest are pharmaceutical excipients, such as magnesium stearate. Normast 600 mg sachets is a second formulation, developed for sublingual use, containing 60% palmitoylethanolamide, excipients and more than 30% sorbitol, a sweetener. Normast is quite popular in Italy. If we analyse the number of hits of the word Normast in Italy and Italian language only, we find more than 75.000 hits. Normast seems to have been introduced in the Italian market around 2006-2007, when we find first entries in the net, in fora were people are asking questions about Normast.

Pelvilen 200 mg and Pelvilen Forte 400 mg

Pelvilen consists of 400 and 200 mg tablets, and each tablet contains around 50% palmitoylethanolamide. The other 50% are consisting of excipients and a resveratrol. Pelvilen is positions by the producer as a painkiller or mast cell modifyer for pelvic pains, such as mestrual pains and endometriosis. The added value of the resveratrol (polydatin)  has never been substantiated, and no trials have been published or conducted so far comparing the analgesic effect of either Normast tablets or Normast sachets to Pelvilen. Furthermore, the bioavailability of resveratrols in general is highly influenced by several factors such as the food matrix and most probably also the tablet matrix. [1]

Normast  300 mg, Normast 600 mg and Normast sachets 600 mg are all produced in Italy, based on formulations developed by the company Epitech, and the brand has also been introduced by medical reps of Epitech to physicians.

PeaPure 400 mg

PeaPure is a brand introduced in 2012 by the company Russell Science Ltd, and the 400 mg capsules are produced in the Netherlands according to a procedure developed by the company. The fiormulation is optimzed to contain pure palmitoylethanolamide only, without any excipients, or sweeteners. The capsules are 100% vega cepsules. Each capsule contains 400 mg palmitoylethanolamide, and thus the content of pure PEA is the highest of all branded formulations. The company therfore branded the formulation as PeaPure, to indicate the essence of this formution, being the pure palmitoylethanolamide.

 

Palmitoylethanolamide formulations and GMP

Nutraceuticals are not required to be produced according to Good Manufacturing Practices (GMP). The only palmitoylethanolamide formulation of all above were a certificate of analysis is made available for the audience is for PeaPure; on the website of JP Russell Science a certificate of GMP can be downloaded. For Normast 300 mg, Normast 600 mg tablets and Normast 600 mg Sachets, as well as for Pelvilen 200 mg and 400 mg the Italian company claims a GMP level, and probably this is correct, but it cannot be checked.

There are other palmitoylethanolamide formulations available via the internet, and these never are supported by any GMP claim. We know that some of these formulations are quite dubious, as all kinds of chemicals are mixed, mostly from herbal origin. Therefore we always recommend to select a PEA formulation which has been documented to be produced according to the highest standards of GMP.

Palmitoylethanolamide in clinical trials and clinical experience

Palmitoylethanolamide first has been explored in the 70s and 80s as Impulsin, a simple formulation containing PEA in a number of trials in respiratory infections and flu, in a total of 2000 patients. From the 90s onwards PEA has been evaluated in other states, such as chronic pain states, as simple formulations and since 2007 also as formulations mentioned above. PEA in the most pure form (99% purity) has been extensively evaluated in a great many animal experiments, were all parenteral as well as oral administration routes selected always yielded positive results in a dose range beginning at 10 mg/ kg bodyweight. [2]

PEA in all formulations used never gave rise to any unwanted or troublesome side effects. This is quite understandable, as PEA is easily synthesized in membranes of neurons and immune cells, and can also easily be broken down via intracellular enzymes into fragments, which are recycled in the membranes. ALthough formal kinetic studies are absent, it is highly unlikely PEA will be a burden on renal and/or hepatic clearance.