Now... get it why I have a bug up my ass about all of this?
Veggie" Capsules May Be Far From "Natural"Veggie" Capsules May Be Far From "Natural"
Sunday, November 4th 2012 at 4:00 am
Dr. Rivkah Roth
Use of Semi-synthetic "Hypromellose" in Supplements, Vitamins, Medications and Foods Adds Up!
Initially used in small amounts, hypromellose today accumulates in uncontrolled, possibly excessive amounts from accumulated daily consumption of vitamin, mineral and supplement capsules, time-released prescription medicines, eye drops and lubricants, growing use in gluten-free, egg-free, and other processed foods—not to mention the daily exposures to commercial and environmental uses.
Industrial Uses of Hypromellose
Primary commercial uses of hypromellose as a water retention, binding and lubricating agent include:
* construction materials
* cement binders
* gypsum products
* tile adhesives
Pharmaceutical and Commercial Uses of Hypromellose
Increasingly, hypromellose figures as the only or main ingredient of non-animal derived gel capsules (so-called "veggie capsules") in natural supplements and prescription medicines.
Other common uses include the coating of prescription medicine tablets and suppositories, injected joint lubricants, a large selection of eye drops and ophthalmic solutions, and more.
In short, we find hypromellose in:
Results. The toxicity ranking of the tear substitutes correlated in all assays. The ATP assay was the most sensitive, followed by ethidium cell permeability, and finally the esterase activity. Preserved hypromellose was more toxic than the unpreserved preparation. Among natural tear substitutes, natural saliva was most toxic. Isotonic saliva and 50% serum were of similar toxicity, and 100% serum was least toxic. Natural tear substitutes were—except for natural saliva—less toxic than unpreserved hypromellose. Hypotonicity, but not amylase, was the major toxic effect associated with saliva. The dilution of serum with chloramphenicol induced toxicity.dental applications
foods (especially "gluten free" or "egg free")
Not a "Natural" Compound
Hypromellose is chemically extruded from wood and/or cotton fiber. Although it is chemically extruded it is considered "safe for vegetarians" and, unfortunately, represented in a superficial manner as "natural."
The Codex Alimentarius lists hypromellose under carbon based substances as E464. The FDA has considered it "G.R.A.S." (generally recognized as safe)—without any further need for proof of harmlessness, even in larger amounts (see the following research conclusions arrived at by—note!—DOW Chemicals).
On the basis of the summarized toxicology literature as well as the JECFA toxicological evaluation of modified celluloses, including HPMC, Dow concludes that HPMC is GRAS for general use in food of at intake levels up to 20 g/p/d (GRAS Notice No. GRN 000213).So, the decision becomes ours on how much, if any, we are willing to ingest or use topically.
Hypromellose or hydroxypropyl methylcellulose (HPMC) is an inert, viscous and elastic semi-synthetic phthalate polymer. Latter is worth repeating.
Please note: Hypromellose classifies as:
- a semi-synthetic and
- a polymer and
- a phthalate!
Are the designations of "Polymer" and "Phthalate" raising warning flags yet?
Food for Thought
As we have seen, hypromellose is finding common use as an emulsifier and thickening agent in medications, foods and commercial products as well as a slow-release mechanism of choice for a huge number of supplements and prescription medications.
Most commonly we encounter hypromellose as a gelatinous solution. When dissolved in water, it forms a homogenous colloid.
However, in its solid (powdered) state, the higher its concentration, the lower the temperature required to turn it into a combustible and prompt a powerful reaction when confronted with oxidizing particles and agents.
Latter particularly raises concerns when we consider the natural acidity and temperatures in excess of the specified threshold of 25 degrees Celsius inside our gastrointestinal tract.
The fact that hypromellose is a semi-synthetic does not make it "only half as dangerous" when compared to any full synthetics. It still is a polymer, a broad class of compounds that includes everything from synthetics plastics (Bakelite, neoprene, nylon, polyethylene, polypropylene, PVC, synthetic rubber, silicon) to the natural polymers such as amber, cellulose (wood, paper), natural rubber, shellac, silk, wool.
Unknown Interaction Between Bio-Polymers and Synthetic Polymers
Semi-synthetic polymers such as hypromellose closely resemble natural "biopolymers" (polynucleotides, polypeptides, polysaccharides, etc.) such as are involved in the formation of our DNA and RNA.
To date we do not know if there is any danger of our body misinterpreting the semi-synthetic hypromellose as a natural polymer and replacing part of our genetic structure.
Still not concerned about this semi-synthetic potentially masquerading as natural building blocks?
Due to the fact that hypromellose has been classified as GRAS by the FDA there is little relevant research available when it comes to comparing natural with semi-synthetic polymers.
Safety assessments of hypromellose intake vary. Differing from the above quoted DOW Chemical research results, a 2007 research estimates it at 5mg/kilogram bodyweight/day based on rat research.
However, semi-synthetic compositions change and new safety ratings are yet to be established. What does not seem to enter new research is the ever increasing cumulative daily intake from "natural" supplements, prescription medications, glutenfree and other processed food products, and environmental exposures.
Make-Believe Foods Partially "Artificial"
With the increase in non-celiac and/or celiac glutensensitivity, food manufacturers experiment with hypromellose as a gluten replacement in bread dough   due to its ability to trap liquids and the air bubbles formed by yeast.
Unverified predictions claim that hypromellose-containing whole grain breads will lower cholesterol levels. Clearly, such an assumption is open to interpretation:
- Is it indeed the presence of the semi-synthetic polymer hypromellose that lowers cholesterol levels?
- Is it the fiber part of hypromellose that affects the cholesterol levels?
- Is the drop in cholesterol levels due to the polymer not being absorbed?
- Or, is there a link with gluten and avoidance of glutens that lowers cholesterol levels?
These are some of those research questions that are not addressed by questionable research assumptions and that show how results can create false impressions, lead to false conclusions, and result in increased use of a questionable substance.
What happened to the Hippocratic Oath of "Do No Harm"?
-  http://www.ncbi.nlm.nih.gov/pubmed/23078551 Drug Dev Ind Pharm. 2012 Oct 19. [Epub ahead of print] Production of extended release mini-tablets using directly compressible grades of HPMC.
-  http://www.ncbi.nlm.nih.gov/pubmed/22652130 Int J Pharm. 2012 Sep 15;434(1-2):503-6. Epub 2012 May 28. On the performance qualification of hypromellose capsules.
-  http://www.ncbi.nlm.nih.gov/pubmed/22342777 Eur J Pharm Biopharm. 2012 May;81(1):184-9. Epub 2012 Feb 11. Supersaturation in human gastric fluids.
-  http://www.ncbi.nlm.nih.gov/pubmed/17868503 Curr Med Res Opin. 2007 Nov;23(11):2629-36. Efficacy, tolerability and comfort of a 0.3% hypromellose gel ophthalmic lubricant in the treatment of patients with moderate to severe dry eye syndrome.
-  http://www.ncbi.nlm.nih.gov/pubmed/16898402 Ophthalmic Surg Lasers Imaging. 2006 Jul-Aug;37(4):344-6. Artificial tear gel as a gonioscopic and contact lens ophthalmoscopy fluid.
-  http://www.ncbi.nlm.nih.gov/pubmed/23079749 Eye (Lond). 2012 Oct 19. doi: 10.1038/eye.2012.211. [Epub ahead of print] The effect of pH, dilution, and temperature on the viscosity of ocular lubricants-shift in rheological parameters and potential clinical significance.
-  http://www.iovs.org/content/42/5/948.abstract Toxicity of Natural Tear Substitutes in a Fully Defined Culture Model of Human Corneal Epithelial Cells
-  http://www.ncbi.nlm.nih.gov/pubmed/21138358 J Periodontol. 2011 Jul;82(7):963-8. Epub 2010 Dec 7. Evaluation of novel adhesive film containing ketorolac for post-surgery pain control: a safety and efficacy study.
-  http://dowac.custhelp.com/app/answers/detail/a_id/6513/~/methocel-upper-limit-on-the-amount-of-hypromellose-in-a-pharmaceutical
-  http://www.chemicalland21.com/specialtychem/finechem/HYDROXYPROPYL%20METHYLCELLULOSE%20PHTHALATE.htm Product Identification
-  http://www.ncbi.nlm.nih.gov/pubmed/22169271 Environ Health Perspect. 2012 Mar;120(3):379-84. Epub 2011 Dec 8. Identification of phthalates in medications and dietary supplement formulations in the United States and Canada.
-  http://www.ncbi.nlm.nih.gov/pubmed/23072204 Int J Pharm Compd. 2012 Sep-Oct;16(5):434-7. Compounding of slow-release niacinamide capsules: feasibility and characterization.
-  http://www.ncbi.nlm.nih.gov/pubmed/22961412 AAPS PharmSciTech. 2012 Sep 8. [Epub ahead of print] Effect of Formulation Conditions on Hypromellose Performance Properties in Films Used for Capsules and Tablet Coatings.
-  http://www.ncbi.nlm.nih.gov/pubmed/17723258 Food Chem Toxicol. 2007 Dec;45(12):2341-51. Epub 2007 Jul 26. Safety assessment of hydroxypropyl methylcellulose as a food ingredient.
-  http://www.ncbi.nlm.nih.gov/pubmed/21189014 J Agric Food Chem. 2011 Jan 26;59(2):741-6. Epub 2010 Dec 28. Physical and sensory properties of all-barley and all-oat breads with additional hydroxypropyl methylcellulose (HPMC) β-glucan.
-  http://www.ncbi.nlm.nih.gov/pubmed/22671523 J Food Sci. 2012 Jun;77(6):C684-9. doi: 10.1111/j.1750-3841.2012.02739.x. Effect of HPMC on the quality of wheat-free bread made from carob germ flour-starch mixtures.
-  http://www.ncbi.nlm.nih.gov/pubmed/22111686 Int J Food Sci Nutr. 2012 Jun;63(4):491-7. Epub 2011 Nov 24. Using white sorghum flour for gluten-free breadmaking.
-  http://www.ncbi.nlm.nih.gov/pubmed/21535827 J Food Sci. 2011 Apr;76(3):E274-82. doi: 10.1111/j.1750-3841.2011.02088.x. How do xanthan and hydroxypropyl methylcellulose individually affect the physicochemical properties in a model gluten-free dough?