DOI: https://doi.org/10.15587/2519-4852.2017.113517

Quality assessment and stability study of compounded furosemide syrup

Deghinmotei Alfred-Ugbenbo, Oleksandr Zdoryk, Viktoria Georgiyants

Abstract


Compounded oral preparations, made with use of manufactured products as sources of active pharmaceutical ingredients, are characterized by short beyond-use-dates due to their instability.

Aim: The aim of this study is to investigate the physical, chemical and microbiological stability of compounded furosemide syrups within a 30 days period.

Methods: Batches of 5 mg/ml compounded syrups, using furosemide substance and commercial tablets (two brands) as sources of active pharmaceutical ingredients, were stored in the dark at 5±3 °C and 23±2 °C and examined at days 0, 7, 15, 23, and 30 for changes in physical (pH, formation of colour, gas, odour and changes in viscosity), chemical and microbial stability. A stress test was conducted in order to distinguish signs of chemical instability using a stability-indicating thin-layer chromatographic method. Bacterial inoculation of these samples were examined for microbial stability based on the total aerobic microbial count (TAMC <100), the total combined yeasts/moulds count (TYMC <10) and absence of Escherichia coli.

Results: Throughout the storage period the investigated syrups showed no extra spots on the chromatogram, no significant changes in pH, colour, odour, gas formation, viscosity. On day 30, the content (≥99.3%) of furosemide, total aerobic microbial count (< 102), total combined yeasts/moulds count (<101) in studied samples were within acceptable limits. Stressed samples showed presence of extra and diminished spots.

Conclusions: Extemporaneous syrups of furosemide substance and dispersed furosemide tablets, stored in glass bottles in the dark at 5±3 °C and 23±2 °C, was found to be physically, chemically and microbiologically stable for at least 30 days

Keywords


furosemide; syrup; compounded preparations; in-pharmacy control; stability; quality assessment; thin layer chromatography

Full Text:

PDF

References


Giam, J. A., McLachlan, A. J. (2008). Extemporaneous product use in paediatric patients: a systematic review. International Journal of Pharmacy Practice, 16 (1), 3–10. doi: 10.1211/ijpp.16.1.0002

Allen, L. V. (2016). The Art, Science, and Technology of Pharmaceutical Compounding. Washington D.C.: American Pharmacists Association. doi: 10.21019/9781582122632

Diorio, L., Thomas, D. (2009). Evaluating stability data understanding beyond-use dating for compounded sterile preparations. Pharmacy, purchasing & products, 4, 12–14.

Pharmaceutical Compounding. The United States Pharmacopeia (2016). Rockville: The United States Pharmacopeial Convention, 2016.

Mason, B., Parker, D., Lott, R. (2013). Capstone pharmacy review. Burlington: Jones & Bartlett Learning, 107–108.

Pharmaceutical Compounding – Nonsterile Preparations <795>. Available at: http://www.usp.org/compounding/general-chapter-795

Stoehr, N. (2017). Compound Academy Solutions and Suspensions. American College of Apothecaries, 22–71. Available at http://acainfo.org/wp-content/uploads/2017/07/L5-Compound-Academy-Solutions-and-Suspensions.pdf

McNulty, J. P., Muller, G. (2014). Compounded Drugs of Value in Outpatient Hospice and Palliative Care Practice. Int J Pharm Compd., 18 (30), 190–200.

Allen, L. V. (2011). Stability of Extemporaneously Prepared Oral Liquid Formulations – Part VIII. Secundum Artem, 16 (3), 1–6.

Salgado, A. C., Rosa, L., Duarte, A., Almeida, A. J. (2005). Stability of spironolactone in an extemporaneously prepared aqueous suspension: the importance of microbiological quality of compounded paediatric formulations. The European Journal of Hospital Pharmacy Science, 11 (3), 68–73.

Niazi, K. (2009). Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products. New York: Informa Healthcare. doi: 10.3109/9781420081244

Alfred-Ugbenbo, D., Zdoryk, O. A., Georgiyants, V. A., Schnatz, R. (2016). Compounding in Nigeria. International Journal of Pharmaceutical Compounding, 20 (3), 189–192.

Allen, L. V. (1997). A formulation for preparing Syrup NF. International Journal of Pharmaceutical Compounding, 2 (1), 111.

State Pharmacopoeia of Ukraine (2014). Kharkiv: State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines».

Alfred-Ugbenbo, D., Zdoryk, O. A., Georgiyants, V. A. (2017). Validation of analytical method for determination of furosemide in extemporaneous syrup. Medical and Clinical Chemistry, 19 (2), 5–11. doi: 10.11603/mcch.2410-681x.2017.v0.i2.7859

European pharmacopoeia (2011). Strasbourg: Council of Europe.

Florence, A., Siepmann, J. (2009). Modern Pharmaceutics. CRC Press, 1216. doi: 10.1201/b14445

Aremu, O. I., Oduyela, O. O. (2015). Evaluation of metronidazole suspensions. African Journal of Pharmacy and Pharmacology, 9 (12), 439–450. doi: 10.5897/ajpp2014.4036

Lam, M. S. H. (2011). Extemporaneous Compounding of Oral Liquid Dosage Formulations and Alternative Drug Delivery Methods for Anticancer Drugs. Pharmacotherapy, 31 (2), 164–192. doi: 10.1592/phco.31.2.164


GOST Style Citations


Giam, J. A. Extemporaneous product use in paediatric patients: a systematic review [Text] / J. A. Giam, A. J. McLachlan // International Journal of Pharmacy Practice. – 2008. – Vol. 16, Issue 1. – P. 3–10. doi: 10.1211/ijpp.16.1.0002 

Allen, L. V. The Art, Science, and Technology of Pharmaceutical Compounding [Text] / L. V. Allen. – Washington D.C.: American Pharmacists Association, 2016. doi: 10.21019/9781582122632 

Diorio, L. Evaluating stability data understanding beyond-use dating for compounded sterile preparations [Text] / L. Diorio, D. Thomas // Pharmacy, purchasing & products. – 2009. – Vol. 4. – P. 12–14.

Pharmaceutical Compounding. The United States Pharmacopeia [Text]. – 39th ed. – Rockville: The United States Pharmacopeial Convention, 2016.

Mason, B. Capstone pharmacy review [Text] / B. B. Mason, D. Parker, R. Lott. – Burlington: Jones & Bartlett Learning, 2013. – P. 107–108.

Pharmaceutical Compounding – Nonsterile Preparations <795> [Electronic resource]. – Available at: http://www.usp.org/compounding/general-chapter-795

Stoehr, N. Compound Academy Solutions and Suspensions [Text] / N. Stoehr // American College of Apothecaries. – 2017. – P. 22–71. – Available at http://acainfo.org/wp-content/uploads/2017/07/L5-Compound-Academy-Solutions-and-Suspensions.pdf

McNulty, J. P. Compounded Drugs of Value in Outpatient Hospice and Palliative Care Practice [Text] / J. P. McNulty, G. Muller // Int J Pharm Compd. – 2014. – Vol. 18, Issue 30. – P. 190–200.

Allen, L. V. Stability of Extemporaneously Prepared Oral Liquid Formulations – Part VIII [Text] / L. V. Allen // Secundum Artem. – 2011. – Vol. 16, Issue 3. – P. 1–6.

Salgado, A. C. Stability of spironolactone in an extemporaneously prepared aqueous suspension: the importance of microbiological quality of compounded paediatric formulations [Text] / A. C. Salgado, L. Rosa, A. Duarte, A. J. Almeida // The European Journal of Hospital Pharmacy Science. – 2005. – Vol. 11, Issue 3. – P. 68–73.

Niazi, K. Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products [Text] / K. Niazi. – New York: Informa Healthcare, 2009. doi: 10.3109/9781420081244 

Alfred-Ugbenbo, D. Compounding in Nigeria [Text] / D. Alfred-Ugbenbo, O. A. Zdoryk, V. A. Georgiyants, R. Schnatz // International Journal of Pharmaceutical Compounding. – 2016. – Vol. 20, Issue 3. – P. 189–192.

Allen, L. V. A formulation for preparing Syrup NF [Text] / L. V. Allen // International Journal of Pharmaceutical Compounding. – 1997. – Vol. 2, Issue 1. – P. 111.

State Pharmacopoeia of Ukraine [Text]. – 2nd ed. – Kharkiv: State Enterprise «Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines», 2014.

Alfred-Ugbenbo, D. Validation of analytical method for determination of furosemide in extemporaneous syrup [Text] / D. Alfred-Ugbenbo, O. A. Zdoryk, V. A. Georgiyants // Medical and Clinical Chemistry. – 2017. – Vol. 19, Issue 2. – P. 5–11. doi: 10.11603/mcch.2410-681x.2017.v0.i2.7859 

European pharmacopoeia [Text]. – 7th ed. – Strasbourg: Council of Europe, 2011.

Florence, A. Modern Pharmaceutics [Text] / A. Florence, J. Siepmann. – CRC Press, 2009. – 1216 p. doi: 10.1201/b14445 

Aremu, O. I. Evaluation of metronidazole suspensions [Text] / O. I. Aremu, O. O. Oduyela // African Journal of Pharmacy and Pharmacology. – 2015. – Vol. 9, Issue 12. – P. 439–450. doi: 10.5897/ajpp2014.4036 

Lam, M. S. H. Extemporaneous Compounding of Oral Liquid Dosage Formulations and Alternative Drug Delivery Methods for Anticancer Drugs [Text] / M. S. H. Lam // Pharmacotherapy. – 2011. – Vol. 31, Issue 2. – P. 164–192. doi: 10.1592/phco.31.2.164 







Copyright (c) 2017 Deghinmotei Alfred-Ugbenbo, Oleksandr Zdoryk, Viktoria Georgiyants

Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.

ISSN 2519-4852 (Online), ISSN 2519-4844 (Print)