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NOW FOODS
Disintegration of tablets
By Neil E. Levin, CCN, DANLA
Every lot of each NOW formula that is made into tablet form is tested for proper disintegration to ensure that you get the full benefit of the ingredients. NOW has a QC (Quality Control) department with a physical testing lab that does disintegration tests on tablets. Our trained technicians measure disintegration of the tablet samples using USP method <2040> on accurately calibrated equipment. This is the accepted industry method.
While the pharmacopeia disintegration test method is the accepted industry standard, its recommended times for disintegration are simply not appropriate or accepted for all dietary supplements. The pharmaceutical compendial standard for disintegration of vitamins and minerals is to allow no greater than 30 minutes for tablets and 45 minutes for capsules; which actually is counterintuitive, considering that capsules normally are believed to disintegrate more quickly than tablets. In fact, this difference is well-accepted by consumers.
Furthermore, many dietary supplements are formulated to contain natural ingredients other than vitamins and minerals, with natural physical characteristics that can vary. Since food often lingers in the stomach for an hour or two during digestion and most vitamins are designed to be taken with meals, the 30 minute recommended standard based on a drug model is unnecessary and unrealistic for many natural products. There is no sound reason to apply this model to formulas containing ingredients other than isolated vitamins and minerals.
NOW has a specific specification for disintegration of each tableted product, typically 45 minutes. Capsules are typically tested to disintegrate within a 40 minute window, but some capsule materials (hard 2-piece gelatin, gelatin softgels, cellulose or polysaccharide Vcaps®) disintegrate within different timeframes that may be shorter. Of course, enteric coated and sustained release formulas will take longer to disintegrate, by design.
Advanced nutrient forms - such as coenzyme forms of vitamins or chelated minerals - may actually be degraded by excessive time in the acidic stomach. This may be a cause for concern if tablets disintegrate too quickly.
NOW Foods sets its own standards for disintegration times based on manufacturing experience, product design and consumer acceptance. We are confident that every lot produced in our facility using independently audited Good Manufacturing Practices (GMP) meets all of our critical specifications.
For example, during 2005 and 2006 all 20 Adam Multivitamin tablet lots manufactured by NOW Foods passed our validated disintegration testing and met specifications for release. Disintegration times for this particular formula ranged between 20-40 minutes, with a maximum of 45 minutes allowed. Testing by an independent lab has confirmed that samples from one lot of Adam tablets disintegrated within 40 minutes, meeting NOW’s own specification.
You can be assured that the highly skilled Quality Control Technicians at NOW Foods continually monitor our production of tablets and test every lot for proper disintegration within our specified timeframes. This competence ensures that the contents of our tablets will be available because the tablet will deliver the active ingredients to your stomach.
REFERENCES:
From the NIH Institute of Medicine (IOM) website: "The Tolerable Upper Intake Level (UL) for niacin for adults is 35 mg/day, which was based on flushing as the critical adverse effect."http://books.nap.edu....=6015&page=123
2. Although nicotinamide appears not to be associated with flushing effects, a UL for nicotinic acid that is based on flushing is considered protective against potential adverse effects of nicotinamide.http://books.nap.edu....=6015&page=142
3. "Nicotinic acid is a safe, broad-spectrum lipid agent shown to prevent cardiovascular disease, yet its widespread use is limited by the prostaglandin D(2) (PGD(2)) mediated niacin flush...The PGD(2) secretion was dependent on the concentration of nicotinic acid and the time of exposure. Nicotinuric acid, but not nicotinamide, also induced PGD(2) secretion. Meyers CD, Liu P, Kamanna VS, Kashyap ML. Nicotinic acid induces secretion of prostaglandin D(2) in human macrophages: An in vitro model of the niacin flush. Atherosclerosis. 2006 Aug 29; [Epub ahead of print] PMID: 16945375
4. Bolzano K, Krempler F, Haslauer F. [Treatment of various types of hyperlipoproteinaemia with a combination of Mg-chlorophenoxy-isobutyrate and mesoinositol-hexanicotinate (author's transl)]. Arzneimittelforschung. 1979;29(10):1621-4. German. PMID: 583231
5. The Tolerable Upper Intake Level (UL) developed here applies to all forms of niacin added to foods or taken as supplements (e.g., immediate release, slow or sustained-release nicotinic acid, and niacinamide [nicotinamide]). Adverse effects such as nausea, vomiting, and signs and symptoms of liver toxicity have been observed at nicotinamide intakes of 3,000 mg/day (Rader et al., 1992) compared with intakes of nicotinic acid of 1,500 mg/day (McKenney et al., 1994). http://books.nap.edu....=6015&page=140
6. Meyers CD, Carr MC, Park S, Brunzell JD. Varying cost and free nicotinic acid content in over-the-counter niacin preparations for dyslipidemia. Ann Intern Med 2003;139:996–1002.
7. Stern RH, Spence JD, Freeman DJ, Parbtani A. Tolerance to nicotinic acid flushing. Clin Pharmacol Ther 1991;50:66–70.
8. Gray DR, Morgan T, Chretien SD, Kashyap ML. Efficacy and safety of controlled-release niacin in dyslipoproteinemic veterans. Ann Intern Med 1994;121:252–8.
9. Ring EFJ, Porto LO, Bacon PA. Quantitative thermal imaging to assess inositol nicotinate treatment for Raynaud's syndrome. J Int Med Res. 1981;9:393-400.
10. O'Hara J, Jolly PN, Nicol CG. The therapeutic efficacy of inositol hexanicotinate (Hexopal®) in intermittent claudication: A controlled trial. Br J Clin Pract. 1988;42:377-383.
11. Murphy R. The effect of inositol hexanicotinate (Hexopal) in patients with Raynaud's syndrome. Clin Trials J. 1985;22:521-529.
12. Kiff RS. Does inositol hexanicotinate (Hexopal) influence intermittent claudication? Br J Clin Pract. 1988;42:141-145.
13. Head A. Treatment of intermittent claudication with inositol nicotinate. Practitioner. 1986;230:49-54.
14. Eur J Clin Pharmacol. 1979 Aug;16(1):11-5. Nocturnal inhibition of lipolysis in man by nicotinic acid and derivatives. Kruse W, Kruse W, Raetzer H, Heuck CC, Oster P, Schellenberg B, Schlierf G. PMID: 499296 [PubMed - indexed for MEDLINE]
15. Welsh AL, Ede M. Inositol hexanicotinate for improved nicotinic acid therapy. Int Record Med. 1961;174:9-15.
16. Hammerl H, Kraenzyl CH, Sudlar M. Metabolic studies for determination of the action mechanism of a ß-sympathometic. Wein Klin Woschenschr. 1968;80:269.
17. Sommer H. Nicotinic acid levels in the blood and fibrinolysis under the influence of the hexanicotinic ester of m-inositol. Arzneim Forsch. 1975;15:1337.
18. Dorner VG, Fischer FW. The influence of m-inositol hexanicotinate ester on the serum lipids and lipoproteins. Arzneim Forsch. 1961;11:110-113.
19. El-Eneim AMA, Hafez YS, Salem H, Abdel M. The role of nicotinic acid and inositol hexanicotinate as anticholesterolemic and antilipemic agents. Nutr Reports Int. 1983;28:899-911.
20. Mercier J, Gavend MR, Dessaigne S. Effect of inositol and its derivatives on hypercholesterolemic rabbits. Cong Union Therap Intern (Brussels). 1963;8:11.
21. Kruse W, Kruse W, Raetzer H, et al. Nocturnal inhibition of lipolysis in man by nicotinic acid and derivatives. Eur J Clin Pharmacol. 1979;16:11-15.
22. Chromate: http://www.interheal...h/research.aspx
23. Preuss HG, Grojec PL, Lieberman S and Anderson RA, Effects of Different Chromium Compounds on Blood Pressure and Lipid Peroxidation in Spontaneously Hypertensive Rats, Clinical Nephrology, 47:325-330, 1997
24. T. Yasmin, M.A., Shara, D. Bagchi, A. Kincaid, A. Limpach, R. Sandstrom, and M. Bagchi, Long-Term Safety Evaluation of a Novel Oxygen-Coordinated Niacin-bound Chromium (III) Complex, Annual Meeting of the American College of Nutrition, Reno, Nevada, Abs. 95, Pg. 465, Vol. 25, No. 5, October 5-8, 2006
25. M. Shara, T. Yasmin, A.E. Kincaid, A.L. Limpach, J. Bartz, K.A. Brenneman, A.Chatterjee, M. Bagchi, S.J. Stohs and D. Bagchi. Safety and toxicological evaluation of a novel niacin-bound chromium (III) complex. Journal of Inorganic Biochemistry 99: 2161-2183 (2005).
26. McCarty MF. Co-administration of equimolar doses of betaine may alleviate the hepatotoxic risk associated with niacin therapy. Med Hypotheses. 2000 Sep;55(3):189-94. PMID: 10985907."