Skip to main content
SpringerLink
Log in

Dissolution Testing for Bioavailability of Over-the-Counter (OTC) Drugs—a Technical Note

  • Brief/Technical Note
  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4

REFERENCES

  1. Drug applications for over-the-counter (OTC) drugs, http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/over-the-counterdrugs/default.htm. Accessed on 10/19/2012

  2. FDA Guidance for Industry. “Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System”. Food and Drug Administration, Center for Drug Evaluation and Research, August 2000.

  3. pKa’s of drugs and reference compounds, http://web.squ.edu.om/med-Lib/MED_CD/E_CDs/A%20Practical%20Guide%20to%20Contemporary%20Pharmacy%20Practice/pdf/pKa-table.pdf. Accessed on 3/23/2012.

  4. Drug Bank, http://www.drugbank.ca/drugs/DB00874. Accessed on 7/17/12.

  5. Abu TM, Serajuddi N, Charle S, Jarowsk I. Effect of diffusion layer pH and solubility on the dissolution rate of pharmaceutical bases and their hydrochloride salts I: phenazopyridine. J Pharm Sci. 1985;74(2):142–7.

    Article  Google Scholar 

  6. ASTM method E2503-07, Standard practice for qualification of basket and paddle dissolution apparatus.

  7. Moore TW. Dissolution testing: a fast, efficient procedure for degassing dissolution medium. Dissolution Technol. 1996;3:3–5.

    Article  Google Scholar 

  8. World Health Organization. Proposal to waive in vivo bioequivalence requirements for the WHO model list of essential medicines immediate release, solid oral dosage forms. Geneva; October 2005.

  9. Wu C, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22:11–23.

    Article  CAS  PubMed  Google Scholar 

  10. Miyazaki S, Oshiba M, Nadai T. Precaution on use of hydrochloride salts in pharmaceutical formulation. J Pharm Sci. 1981;70(6):594–6.

    Article  CAS  PubMed  Google Scholar 

  11. Miyazaki S, Oshiba M, Nadai T. Unusual solubility and dissolution behavior of pharmaceutical hydrochloride salts in chloride-containing media. Int J Pharm. 1980;6:77–85.

    Article  CAS  Google Scholar 

  12. Miyazaki S, Nakano M, Arita T. A comparison of solubility characteristics of free bases and hydrochloride salts of tetracycline antibiotics in hydrochloric acid solutions. Chem Pharm Bull. 1975;23(6):1197–204.

    Article  CAS  PubMed  Google Scholar 

  13. Miyazaki S, Oshiba M, Nadai T. Common ion effect of chloride on the dissolution properties of papaverine hydrochloride. Chem Pharm Bull. 1981;29(11):3414–7.

    Article  CAS  Google Scholar 

  14. Guidance for industry bioavailability and bioequivalence studies for orally administered drug products—general considerations, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070124.pdf. Accessed on 1/7/2013.

  15. Gao Z. Development of a continuous dissolution/absorption system—a technical note. AAPS PharmSciTech. 2012;13(4):1287–92.

    Article  PubMed Central  PubMed  Google Scholar 

Download references

ᅟ

ᅟ

Disclaimer

Opinions expressed in this report are those of the authors and do not necessarily reflect the views or policies of the FDA.

Author information

Authors and Affiliations

  1. Division of Pharmaceutical Analysis, St. Louis, MO, 63110, USA

    Zongming Gao, Stephanie Clark, Mike Trehy, Terry Moore, Benjamin Westenberger, Lucinda Buhse & John Kauffman

  2. Office of Pharmaceutical Quality, Silver Spring, MD, 20993, USA

    Lawrence Yu

  3. USPHS Officer assigned to Division of Nonprescription Regulation Development, Silver Spring, MD, 20993, USA

    Benjamin Bishop & Lydia Velazquez

  4. Office of New Drug Quality Assessment, Silver Spring, MD, 20993, USA

    Scott Furness

Authors
  1. Zongming Gao
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lawrence Yu
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Stephanie Clark
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Mike Trehy
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Terry Moore
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Benjamin Westenberger
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Lucinda Buhse
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. John Kauffman
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Benjamin Bishop
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Lydia Velazquez
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Scott Furness
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Zongming Gao.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gao, Z., Yu, L., Clark, S. et al. Dissolution Testing for Bioavailability of Over-the-Counter (OTC) Drugs—a Technical Note. AAPS PharmSciTech 16, 1227–1233 (2015). https://doi.org/10.1208/s12249-015-0297-x

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1208/s12249-015-0297-x

KEY WORDS

Search

Navigation