Tags

Type your tag names separated by a space and hit enter

Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products.
Am J Health Syst Pharm. 2006 Nov 01; 63(21):2128-34.AJ

Abstract

PURPOSE

The dissolution profiles of nonprescription extended-release niacin and inositol niacinate products were studied using the prescription extended-release niacin, Niaspan, as a reference.

METHODS

Seven nonprescription extended-release and 12 nonprescription inositol niacinate products were collected from community and online pharmacies in the United States. Extended-release Niaspan was used as a reference. Dissolution profiles were examined by the United States Pharmacopoeia dissolution test, using a paddle method. Release samples were removed every 30 minutes for up to 240 minutes. Niacin was quantified by high-performance liquid chromatography.

RESULTS

Ten out of the 12 inositol niacinate products were capsules and 6 of the 7 extended-release formulations were tablets. During the initial 30-minute dissolution study of inositol niacinate products, free niacin was released to various degrees. One product achieved fast dissolution, with >30% cumulative release of niacin. The cumulative percentage of niacin released at 240 minutes of all inositol niacinate products was statistically different (p < 0.0001). The majority of these products reached a plateau of releasing niacin in one to two hours, which was maintained until the end of the study. Six out of the seven extended-release niacin products had extended-release profiles. Five products showed a statistically higher dissolution rate (p < 0.05) than that of Niaspan.

CONCLUSION

Significant variations in dissolution profiles were noted among the 7 nonprescription extended-release and 12 nonprescription inositol niacinate products in vitro, and their dissolution rates were not comparable to that of the prescription extended-release niacin. Further studies are warranted to correlate such dissolution data with their in vivo efficacy.

Authors+Show Affiliations

College of Pharmacy and Health Sciences, Texas Southern University, Houston, TX 77004, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17057051

Citation

Poon, Ivy O., et al. "Dissolution Profiles of Nonprescription Extended-release Niacin and Inositol Niacinate Products." American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, vol. 63, no. 21, 2006, pp. 2128-34.
Poon IO, Chow DS, Liang D. Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products. Am J Health Syst Pharm. 2006;63(21):2128-34.
Poon, I. O., Chow, D. S., & Liang, D. (2006). Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products. American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, 63(21), 2128-34.
Poon IO, Chow DS, Liang D. Dissolution Profiles of Nonprescription Extended-release Niacin and Inositol Niacinate Products. Am J Health Syst Pharm. 2006 Nov 1;63(21):2128-34. PubMed PMID: 17057051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dissolution profiles of nonprescription extended-release niacin and inositol niacinate products. AU - Poon,Ivy O, AU - Chow,Diana S-L, AU - Liang,Dong, PY - 2006/10/24/pubmed PY - 2007/1/31/medline PY - 2006/10/24/entrez SP - 2128 EP - 34 JF - American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists JO - Am J Health Syst Pharm VL - 63 IS - 21 N2 - PURPOSE: The dissolution profiles of nonprescription extended-release niacin and inositol niacinate products were studied using the prescription extended-release niacin, Niaspan, as a reference. METHODS: Seven nonprescription extended-release and 12 nonprescription inositol niacinate products were collected from community and online pharmacies in the United States. Extended-release Niaspan was used as a reference. Dissolution profiles were examined by the United States Pharmacopoeia dissolution test, using a paddle method. Release samples were removed every 30 minutes for up to 240 minutes. Niacin was quantified by high-performance liquid chromatography. RESULTS: Ten out of the 12 inositol niacinate products were capsules and 6 of the 7 extended-release formulations were tablets. During the initial 30-minute dissolution study of inositol niacinate products, free niacin was released to various degrees. One product achieved fast dissolution, with >30% cumulative release of niacin. The cumulative percentage of niacin released at 240 minutes of all inositol niacinate products was statistically different (p < 0.0001). The majority of these products reached a plateau of releasing niacin in one to two hours, which was maintained until the end of the study. Six out of the seven extended-release niacin products had extended-release profiles. Five products showed a statistically higher dissolution rate (p < 0.05) than that of Niaspan. CONCLUSION: Significant variations in dissolution profiles were noted among the 7 nonprescription extended-release and 12 nonprescription inositol niacinate products in vitro, and their dissolution rates were not comparable to that of the prescription extended-release niacin. Further studies are warranted to correlate such dissolution data with their in vivo efficacy. SN - 1079-2082 UR - https://www.unboundmedicine.com/medline/citation/17057051/Dissolution_profiles_of_nonprescription_extended_release_niacin_and_inositol_niacinate_products_ L2 - https://academic.oup.com/ajhp/article-lookup/doi/10.2146/ajhp060089 DB - PRIME DP - Unbound Medicine ER -