Effect of pH on Pharmaceutical Ingredients / Drugs / Chemicals

Authors

  • Md Amir NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Md Ashfaque Alam NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Md Fauwaz Aftab NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Md Gulam Nabi NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Md Sadre Alam NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Jagdeesh Rathi NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India
  • Sonpal Singh Thakur

DOI:

https://doi.org/10.22270/ajdhs.v2i3.17

Keywords:

Solubility, API, Impurity, Ph

Abstract

The word excipient is derived from the Latin excipere meaning to except, which is simply explained as other than. Pharmaceutical excipients are basically everything other than the active pharmaceutical ingredient. Ideally, excipients should be inert, however, recent reports of adverse reactions have suggested otherwise. Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system. Solubility, which defines the liquid /solid equilibrium, is a key parameter to control a crystallization process. As the API is a weak acid (pKa = 3.7), its solubility increases with the pH. On the basis of the experimental curve of solubility, a model was defined to fit the evolution of the solubility as a function of pH. In the case of this compound, studies revealed a weak influence of the temperature in comparison with the pH. So, the solubility of the compound is slightly impacted by the temperature. Some experiments were carried out in order to compare the solubility of the API, at the same pH and temperature, for different concentrations of impurities found in the process. The results revealed a solubility increase in presence of acetic acid and a high solubility decrease in presence of sodium chloride. By carrying out experiments on common ions salts, the anion chloride Cl− has been identified as the cause of the solubility decrease.

Keywords: Solubility, API, Impurity, Ph

Author Biographies

Md Amir, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

Md Ashfaque Alam, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

Md Fauwaz Aftab, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

Md Gulam Nabi, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

Md Sadre Alam, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

Jagdeesh Rathi, NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

NRI Institute of Pharmaceutical Sciences, 1, Sajjan Singh Nagar, Opposite Patel Nagar, Raisen Road Bhopal 462022, MP, India

References

Avdeef A. Solubility of sparingly-soluble ionisable drugs. Advanced drug delivery reviews, 2007; 59:568-590. https://doi.org/10.1016/j.addr.2007.05.008

Carta R. Solubilities of L-cystine, L-tyrosine, L-leucine and glycine in aqueous solutions at various pH and NaCl concentrations. The Journal of Chemical & Engineering Data. 1996; 41:414-417. https://doi.org/10.1021/je9501853

Granberg RA, Rasmuson AC. Solubility of paracetamol in binary and ternary mixtures of water plus acetone plus toluene. The Journal of Chemical & Engineering Data. 2000; 45:478-483. https://doi.org/10.1021/je990272l

Leontidis E. Hofmeister anion effects on surfactant self-assembly and the formation of mesoporous solids, Current Opinion in Colloid & Interface Science. 2002; 7:81-91. https://doi.org/10.1016/S1359-0294(02)00010-9

Published

15.09.2022

How to Cite

Amir, M. ., Alam, M. A. ., Aftab, M. F. ., Nabi, M. G. ., Alam, M. S. ., Rathi, J. ., & Thakur, S. S. . (2022). Effect of pH on Pharmaceutical Ingredients / Drugs / Chemicals. Asian Journal of Dental and Health Sciences, 2(3), 9–11. https://doi.org/10.22270/ajdhs.v2i3.17

Citations