Incompatibility Studies of Tamsulosin HCl using TGA, DSC and FT-IR

Year 2023, Volume: 43 Issue: 1, 22 - 31, 01.03.2023

Alankar Shrivastava , Ashu Mıttal

https://doi.org/10.52794/hujpharm.1092728

Abstract

The Benign Prostatic Hyperplasia is one of the common old age problems and alpha one adrenoreceptor blockers are commonly used for symptomatic relief. Tamsulosin HCl is selective alpha 1A adrenoreceptor blocker with better tolerability profile and once daily dosing advantage. The present study was undertaken to establish the compatibility of Tamsulosin with several commonly used excipients by using thermo analytical technique viz Thermogravimetry and differential scanning calorimetry used in formulation. The Thermogravimetry and differential scanning calorimetry both results demonstrated that ethyl cellulose, Gelatin and lactose found to be incompatible with Tamsulosin and should be avoided for the pharmaceutical preparation.

Keywords

Differential scanning calorimetry (DSC), Thermogravimetry (TG), Incompatibility study, Fourier transform Infra Red (FTIR), Tamsulosin

References

• 1. McLaren ID, Jerde TJ. Bushman Wade. Role of interleukins, IGF and stem cells in BPH. Differentiation. 2011;82: 237–243.
• 2. Wang Z, Olumi AF. Diabetes, growth hormone-insulin-like growth factor pathways and association to benign prostatic hyperplasia. Differentiation. 2011;82: 261–271.
• 3. Shrivastava A, Gupta VB. Various treatment options for benign prostatic hyperplasia: A current update. J Mid-life Health 2012;3:10-9.
• 4. Briganti A, Capitanio U, Suardi N, Gallina A, Salonia A, Bianchi M, Tutolo M, Girolamo VD, Guazzoni G, Rigatti P, Montorsi F. Benign Prostatic Hyperplasia and Its Aetiologies. European Urology Supplement. 2009;S 8: 865–871.
• 5. Zhang YY, Lu ZZ, Wei H, Han QD. [Sertindole, a novel alpha 1A-adrenoceptor selective antagonist]. Yao Xue Xue Bao. 1997 Jul;32(7):490-5.
• 6. Langan RC. Benign Prostatic Hyperplasia. Prim Care. 2019 Jun;46(2):223-232. doi: 10.1016/j.pop.2019.02.003.
• 7. Duan Y, Grady JJ, Albertsen PC, Helen Wu Z. Tamsulosin and the risk of dementia in older men with benign prostatic hyperplasia. Pharmacoepidemiol Drug Saf. 2018;27(3):340-348. DOI: 10.1002/pds.4361.
• 8. Troost J, Tatami S, Tsuda Y, Mattheus M, Mehlburger L, Wein M, Michel MC. Effects of strong CYP2D6 and 3A4 inhibitors, paroxetine and ketoconazole, on the pharmacokinetics and cardiovascular safety of tamsulosin. Br J Clin Pharmacol. 2011; 72(2): 247–256.
• 9. Gutch PK, Sharma J, Shrivastava A, Jain A, Ganesan K. Thermal analysis of interaction between 2-PAM chloride 4 and various excipients in some binary mixtures by TGA and DSC. J. Therm. Anal. Calorim. 2011; DOI 10.1007/s10973-011-2100-x
• 10. Sharma R, Gutch PK, Ganesan K, Vijayaraghavan R, Jain S, Dubey S. Thermal analysis of interactions between an oxime and excipients in some binary mixtures by differential scanning calorimetry and thermagravimetric analysis. Journal of Pharmacy Research. 2010; 3(3):590-595.
• 11. Ahmed F, Gutch PK, Ganesan K, Vijayaraghavan R. N,N′-dichloro-bis[2,4,6-trichlorophenyl]urea (CC2) and suspending agents used for the preparation of decontamination formulation against chemical warfare agents A study of compatibility by thermoanalytical techniques. J Therm Anal Calorim. 2012; 107:141–147
• 12. Fatima DFC, Flavio SAT, Flavio ADL, Moura FNR. Compatibility study between chlorpropamide and excipients in their physical mixtures. J Therm Anal Calorim. 2009; 97: 355–357
• 13. Filho ROC, Franco PIBM, Conceic EC, Leles MIG. Stability studies on nifedipine tablets using thermogravimetry and differential scanning calorimetry. J Therm Anal Calorim 2009; 97: 343–347.
• 14. Shrivastava A, Sharma J, Gutch PK. Incompatibility studies between α, α'-xylene-p-bis-3,3'(hydroxyiminomethyl) pyridinium dibromide and 14 various commonly used excipients for the preparation of decontamination formulation against chemical warfare agents by thermoanalytical techniques. Curr Pharma Anal. 2012;8(1):107-113.