Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo

Mankulu Kakumba Jocelyn; Mavanga Mabaya Timothy; Bayebila Menanzambi Tresor; Tshienda Katende Milka; Mbenza Puati Adelard; Mbinze Kindenge Jeremi; Kimbeni Malongo Tresor

doi:doi:10.11648/j.ijpc.20210701.12

Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo

Mankulu Kakumba Jocelyn, Mavanga Mabaya Timothy, Bayebila Menanzambi Tresor, Tshienda Katende Milka, Mbenza Puati Adelard, Mbinze Kindenge Jeremi, Kimbeni Malongo Tresor

Published in International Journal of Pharmacy and Chemistry (Volume 7, Issue 1)

Received: 14 December 2020 Accepted: 22 December 2020 Published: 23 February 2021

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Abstract

Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.

Published in	International Journal of Pharmacy and Chemistry (Volume 7, Issue 1)
DOI	10.11648/j.ijpc.20210701.12
Page(s)	5-12
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Stability, Quality Control (QC), Amoxicillin, Potassium Clavulanate

References

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[2]	Faheem A. A., Gamil Q. O. and Farouk A. A. (2016). Quality and stability of Amoxicillin-Potassium Clavulanate drugs marketed in Yemen: Influence of tropical storage conditions, Journal of Chemical and Pharmaceutical Research, 8 (6), 160-166.
[3]	Singh S. and Bakshi M. (2000). Guidance on conduct of stress test to determine inherent stability of drugs, Pharm Technol Asia, Special Issue, 24-36.
[4]	Carstensen J. T. (2000). Drug stability, Principles and Practices, Marcel Dekker-New York.
[5]	John N. A. A., Lawrencia Y. A. and Reimmel K. A. (2014). Stability studies on reconstituted Amoxicillin-Clavulanic Acid oral powder by HPLC Method development and quantification, International Journal of Pharmaceutical Science and Practice, Vol. 3 N°1, 1-12.
[6]	Blanca E. O. M., Maria R. W. K., Elizabeth W. M. and Paulo C. P. R. (2014). Evaluation of the quality and stability of amoxicillin oral suspension, Journal of Applied Pharmaceutical Science, Vol. 4 (07), 038-040.
[7]	Nwokoye P., Oyetunde O. and Akinleye M. (2012). Stability of reconstituted amoxicillin Clavulanate potassium under simulated in-home storage conditions, Journal of Applied Pharmaceutical Science 02 (01), 28-31.
[8]	Lehmann A., Katerere D. R. and Dressman J. (2018). Drug Quality in South Africa, Journal of Pharmaceutical Sciences, 1-26.
[9]	Berry V., Hoover J.; Singley C. and Woodnutt G. (2005). Antimicrob Agents Chemother 49, 908-915.
[10]	White A. R., Kaye C., Poupard J.; Pypstra R., Woodnutt G. and Wynne B. (2004), J. AntimicrobChemother, 53, i1-i20.
[11]	Banker G. S. (2002), Drug products. Rhodes (Eds) Modern pharmaceutics, Marcel Dekker-New York, 1-21.
[12]	N’ghorand T. Y. J. S., Kpaibe S. A. P., Bony N. F., Soko Y. N. and Ake M. (2019). Study of chemical stability of oral suspensions based on amoxicillin, Int. J. Biol. Chem. Sci. 13 (3), 1837-1845.
[13]	Ahuja S. (1998). Marcel Dekker-New York, USA.
[14]	FDA. (2013), Draft Guidance for industry: Stability testing of new drug substances and products Q1a (R2).
[15]	Chaitanya K. A., Chelladurai R., Jeevanantham S., Vignesh R. and Baskaran R. (2012), A novel and high-throughput method for the simultaneous determination of amoxicillin and clavulanic acid in human plasma by liquid chromatography coupled with tandem mass spectrometry, International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 4 Suppl. 3, 648-652.

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Mankulu Kakumba Jocelyn, Mavanga Mabaya Timothy, Bayebila Menanzambi Tresor, Tshienda Katende Milka, Mbenza Puati Adelard, et al. (2021). Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. International Journal of Pharmacy and Chemistry, 7(1), 5-12. https://doi.org/10.11648/j.ijpc.20210701.12

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ACS Style

Mankulu Kakumba Jocelyn; Mavanga Mabaya Timothy; Bayebila Menanzambi Tresor; Tshienda Katende Milka; Mbenza Puati Adelard, et al. Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. Int. J. Pharm. Chem. 2021, 7(1), 5-12. doi: 10.11648/j.ijpc.20210701.12

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AMA Style

Mankulu Kakumba Jocelyn, Mavanga Mabaya Timothy, Bayebila Menanzambi Tresor, Tshienda Katende Milka, Mbenza Puati Adelard, et al. Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. Int J Pharm Chem. 2021;7(1):5-12. doi: 10.11648/j.ijpc.20210701.12

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@article{10.11648/j.ijpc.20210701.12,
  author = {Mankulu Kakumba Jocelyn and Mavanga Mabaya Timothy and Bayebila Menanzambi Tresor and Tshienda Katende Milka and Mbenza Puati Adelard and Mbinze Kindenge Jeremi and Kimbeni Malongo Tresor},
  title = {Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {7},
  number = {1},
  pages = {5-12},
  doi = {10.11648/j.ijpc.20210701.12},
  url = {https://doi.org/10.11648/j.ijpc.20210701.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20210701.12},
  abstract = {Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.},
 year = {2021}
}

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TY  - JOUR
T1  - Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo
AU  - Mankulu Kakumba Jocelyn
AU  - Mavanga Mabaya Timothy
AU  - Bayebila Menanzambi Tresor
AU  - Tshienda Katende Milka
AU  - Mbenza Puati Adelard
AU  - Mbinze Kindenge Jeremi
AU  - Kimbeni Malongo Tresor
Y1  - 2021/02/23
PY  - 2021
N1  - https://doi.org/10.11648/j.ijpc.20210701.12
DO  - 10.11648/j.ijpc.20210701.12
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 5
EP  - 12
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20210701.12
AB  - Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.
VL  - 7
IS  - 1
ER  -

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Author Information

Mankulu Kakumba Jocelyn

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Mavanga Mabaya Timothy

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Bayebila Menanzambi Tresor

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Tshienda Katende Milka

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Mbenza Puati Adelard

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Mbinze Kindenge Jeremi

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo
Kimbeni Malongo Tresor

Department of Pharmaceutics and Drugs Analysis, Laboratory of Quality Control and Drugs Analysis and Diets Survey (LACOMEDA), Faculty of Pharmaceutical Sciences, University of Kinshasa, Kinshasa, Democratic Republic of the Congo

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APA Style

Mankulu Kakumba Jocelyn, Mavanga Mabaya Timothy, Bayebila Menanzambi Tresor, Tshienda Katende Milka, Mbenza Puati Adelard, et al. (2021). Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. International Journal of Pharmacy and Chemistry, 7(1), 5-12. https://doi.org/10.11648/j.ijpc.20210701.12

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ACS Style

Mankulu Kakumba Jocelyn; Mavanga Mabaya Timothy; Bayebila Menanzambi Tresor; Tshienda Katende Milka; Mbenza Puati Adelard, et al. Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. Int. J. Pharm. Chem. 2021, 7(1), 5-12. doi: 10.11648/j.ijpc.20210701.12

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AMA Style

Mankulu Kakumba Jocelyn, Mavanga Mabaya Timothy, Bayebila Menanzambi Tresor, Tshienda Katende Milka, Mbenza Puati Adelard, et al. Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo. Int J Pharm Chem. 2021;7(1):5-12. doi: 10.11648/j.ijpc.20210701.12

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@article{10.11648/j.ijpc.20210701.12,
  author = {Mankulu Kakumba Jocelyn and Mavanga Mabaya Timothy and Bayebila Menanzambi Tresor and Tshienda Katende Milka and Mbenza Puati Adelard and Mbinze Kindenge Jeremi and Kimbeni Malongo Tresor},
  title = {Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo},
  journal = {International Journal of Pharmacy and Chemistry},
  volume = {7},
  number = {1},
  pages = {5-12},
  doi = {10.11648/j.ijpc.20210701.12},
  url = {https://doi.org/10.11648/j.ijpc.20210701.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ijpc.20210701.12},
  abstract = {Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.},
 year = {2021}
}

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TY  - JOUR
T1  - Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo
AU  - Mankulu Kakumba Jocelyn
AU  - Mavanga Mabaya Timothy
AU  - Bayebila Menanzambi Tresor
AU  - Tshienda Katende Milka
AU  - Mbenza Puati Adelard
AU  - Mbinze Kindenge Jeremi
AU  - Kimbeni Malongo Tresor
Y1  - 2021/02/23
PY  - 2021
N1  - https://doi.org/10.11648/j.ijpc.20210701.12
DO  - 10.11648/j.ijpc.20210701.12
T2  - International Journal of Pharmacy and Chemistry
JF  - International Journal of Pharmacy and Chemistry
JO  - International Journal of Pharmacy and Chemistry
SP  - 5
EP  - 12
PB  - Science Publishing Group
SN  - 2575-5749
UR  - https://doi.org/10.11648/j.ijpc.20210701.12
AB  - Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.
VL  - 7
IS  - 1
ER  -

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