Poster Topical Area: Nutritional Epidemiology

Location: Hall D

Poster Board Number: 773

P20-061 - Disintegration and rupture testing of prescription (Rx) prenatal multivitamin/ mineral (MVM) dosage forms: a pilot study for Dietary Supplement Ingredient Database (DSID)

Monday, Jun 11
8:00 AM – 3:00 PM

Objective: Approximately 75% of pregnant women who participated in NHANES from 1999 to 2006 reported the use of a prenatal MVM. The majority of these prenatal MVM are Rx products distributed only through pharmacies, although an increasing number of prenatal MVM are available over-the-counter. In the U.S., Rx prenatal MVM are not regulated as pharmaceuticals but as dietary supplements. It is unknown whether their manufacturers voluntarily apply specifications that would more closely follow the manufacturing regulations for drugs.


Methods: From a complete list of Rx prenatal MVM sold by retail and mail order pharmacies in time period from 06-2015 to 06-2016, a list of representative products was generated using a probability weighted random sample proportional to market share. Two lots of 24 products representing an estimated 61.2% of the market share are being tested by commercial labs for their chemical content and evaluated against labeled levels for prioritized vitamins (V) and minerals (M) and docosahexaenoic acid (DHA). In addition, each product is being tested for disintegration and dissolution using the United State Pharmacopeia (USP 39) specifications. The USP standards are intended to detect problems that may arise due to misuse of coatings, lubricants, disintegrants, and due to tablet overcompression/overdrying that would affect the release of active ingredients from dosage forms after being swallowed.


Results: The softgels contained V and M along with DHA (n=6), botanicals (1) or docusate sodium (1), or omega-3 fatty acids only (4) (as part of a pack including an MVM tablet). The tablets/caplets contained V and M only (11), along with choline (2) or docusate sodium (3). For the first lot of products, all eight MVM and four fish oil softgels passed the rupture test. For MVM only caplets/tablets, 9 out of 11 passed the disintegration test. Four out of five tablets containing V and M along with choline (2) or docusate sodium (2) failed to disintegrate, both without and with a disk in the vessel.


Conclusions: Our tests suggest that, in contrast to satisfactory performance quality of Rx prenatal MVM in the form of softgels, tablets and caplets of these products do not always meet disintegration standards. This raises concerns that tablets/caplets of Rx prenatal MVM may not release ingredients properly upon consumption.




Funding Source:

Supported by the NIH Office of Dietary Supplements and the USDA Agricultural Research Service.

CoAuthors: Karen Andrews – NDL, BHNRC, USDA; Sushma Savarala – Nutrient Data Laboratory, BHNRC, ARS, USDA; Renata Atkinson – Nutrient Data Laboratory, BHNRC, ARS, USDA; Phuong-Tan Dang – Nutrient Data Laboratory, BHNRC, ARS, USDA; Laura Oh – Nutrient Data Laboratory, BHNRC, ARS, USDA; Malikah, McNeal – Nutrient Data Laboratory, BHNRC, ARS, USDA; Pamela Pehrsson – Nutrient Data Laboratory, BHNRC, ARS, USDA; Johanna Dwyer – Office of Dietary Supplements, NIH; Joseph Betz – Office of Dietary Supplements, NIH; Adam Kuszak – Office of Dietary Supplements, NIH; Rebecca Costello – Office of Dietary Supplements, NIH; Larry Douglass – University of Maryland; Leila Saldanha – Office of Dietary Supplements, NIH

Pavel A. Gusev

Senior Reserach Program Manager
Nutrient Data Laboratory, BHNRC, ARS, USDA
Beltsville, Maryland