Author(s):
Nagashekhara Molugulu, Sathiya Maran, Usha Sundralingam, Rajesh Sreedharan Nair
Email(s):
Nagashekhara.Molugulu@monash.edu
DOI:
10.52711/0974-360X.2025.00850 
Address:
Nagashekhara Molugulu1, Sathiya Maran1, Usha Sundralingam1, Rajesh Sreedharan Nair2
1School of Pharmacy, Monash University Malaysia, Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia.
2Faculty of Science, University of Nottingham, Malaysia Campus, Jalan Broga, 43500 Semenyih, Selangor Darul Ehsan, Malaysia.
*Corresponding Author
Published In:
Volume - 18,
Issue - 12,
Year - 2025
ABSTRACT:
This study was conducted to find out the stability of Chloral hydrate 100 mg/ml in the X-Temp® solution oral suspension system. Various parameters such as physical, chemical and microbiological tests were studied. Physical properties such as pH, specific gravity and visual inspection were carried out at different intervals of 1, 15, 30, 60, 90 and 120 days. Microbiological tests for various organisms such as Pseudomonas, Staphylococcus aureus, Salmonella, E.Coli, Yeast and moulds were studied. In addition, assay was carried out using HPLC to compare the chloral hydrate sample with the standard drug. The Chloral hydrate suspension was stored for 120 days at two different temperatures such as 5ºC and 30ºC using refrigerator and stability chamber respectively. The samples were unchanged or had negligible change in the colour, odour, pH, specific gravity. Over a span of 120 days, there was no microbial growth observed, no alterations in physical attributes, and the assays met the required standards.
Cite this article:
Nagashekhara Molugulu, Sathiya Maran, Usha Sundralingam, Rajesh Sreedharan Nair. Development a Stability of Chloral hydrate in Extemporaneously Compounded Oral Suspension System. Research Journal Pharmacy and Technology. 2025;18(12):5886-0. doi: 10.52711/0974-360X.2025.00850
Cite(Electronic):
Nagashekhara Molugulu, Sathiya Maran, Usha Sundralingam, Rajesh Sreedharan Nair. Development a Stability of Chloral hydrate in Extemporaneously Compounded Oral Suspension System. Research Journal Pharmacy and Technology. 2025;18(12):5886-0. doi: 10.52711/0974-360X.2025.00850 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-12-40
REFERENCES:
1. Bharti Ahirwar. Stability study of Ayurvedic formulation kankasava. Asian J. Pharm. Tech. 2013; 3(1): 01-04.
2. Poonam Kushwaha. Significance of Stability Studies on Degradation Product. Research J. Pharm. and Tech. 2009; 2 (4): 621-627.
3. Janani SK, R. Suresh Kumar, Chenmala Karthika, Vasanthi C, Shaik Rafi Kapoor. Study on Formulation development and shelf life indicating stability of Artesunate loaded Self-nanoemulsifying Drug Delivery System. Research J. Pharm. and Tech. 2019; 12(7): 3228-3236. doi: 10.5958/0974-360X.2019.00543.2.
4. M. Nagajyothi, K. Pramod, E.N. Bijin, Jomon N. Baby, J. Valsalakumari. Accelerated Stability Studies of Atorvastatin Loaded Nanoemulsion Gel. Asian J. Pharm. Tech. 2015; 5(3): 188-191.
5. Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore. Stability Testing of Pharmaceutical Products. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(4): 317-8. doi: 10.52711/0975-4377.2021.00052.
6. Trissel L.A, Drug stability and compatibility issues in drug delivery, The Cancer Bulletin. 1990; 42: 393-398.
7. Yarnykh T. G., Kotvitska A. A., Tykhonov A. I., Rukhmakova O. A. Pharmaceutical Incompatibilities: Causes, Types and Major ways of Overcoming in Extemporaneous Medicinal forms. Research J. Pharm. and Tech. 2020; 13(7): 3459-3465.
8. Carstensen J.T., Rhodes C. Drug Stability: Principles and Practices, 3rd Rev. 2000, Marcel Decker Inc, New York, USA.
9. Florence A.T., Attwood D. Drug stability. In physicochemical principles of pharmacy. 4th Ed. 2006, Pharmaceutical Press, London, UK.
10. Oldham G.B. Formulation and stability of cefuroxime eye-drops. Int. J. Pharm. Pract. 1991; 1: 19-22
11. Barberi-Heyob M., Watelet M. Merlin J.L. Bleger C., Schroeder B. Stability of newly-formulated 5 fluorouracil solutions. Bull. Canc. 1995; 82(12): 1025-31.
12. Bontemps C., Chataigner A, Sautou-Miranda V, Chopineau J. Etude de stabilité d’une solution de céfuroxime pour injection intracamérulaire. Congrès Hopipharm, Marseille 2009.
13. Silva MRM da, Dysars LP, Santos EP dos, Ricci Júnior E. Preparation of extemporaneous oral liquid in the hospital pharmacy. Braz J Pharm Sci [Internet]. 2020; 56: e18358. Available from: https://doi.org/10.1590/s2175-97902019000418358
14. Published by Statista Research Department, Mar 21, 2024 https://www.statista.com/statistics/794860/number-of-public-and-private-hospitals-malaysia/).
15. Malaysia hospital market size, share, price Forecast: Accessd on 22nd April 2024 https://www.expertmarketresearch.com/reports/malaysia-hospital-market
16. Sean Liew Jia Xen Malaysia’s MOH Contract Pharmacists: Stuck in Limbo? 10 June 2022https://mpsypc.com.my/publications/malaysias-moh-contract-pharmacists-stuck-in-limbo/#:~:text=According%20to%20the%20Pharmaceutical%20Services,pharmacists%3D%201%3A1.86) Accessed on 22th April 2024.
17. Liva R. Quality assurance issues in compounding pharmacies. Integrative Medicine. 2006; 5(5):70-72.
18. Haywood, A. and Glass, B.D. Liquid dosage forms extemporaneously prepared from commercially available products–Considering new evidence on stability. Journal of Pharmacy and Pharmaceutical Sciences. 2013; 16(3): 441-455.
19. Schmalfuss I. Oral sedation of pediatric patients for noninvasive radiological procedures: chloral hydrate versus midazolam. J Radiol Nurs. 2005; 24(3): 42–48. doi: 10.1016/j.jradnu.2005.08.004
20. Stern KW, Gauvreau K, Geva T, Benavidez OJ. The impact of procedural sedation on diagnostic errors in pediatric echocardiography [published online June 11, 2014] J Am Soc Echocardiogr. 2014; 27(9): 949–955. doi: 10.1016/j.echo.2014.04.024.
21. Nordt SP, Rangan C, Hardmaslani M, et al. Paediatric chloral hydrate poisonings and death following outpatient procedural sedation. J Med Toxicol. 2014; 10(2): 219–222. doi: 10.1007/s13181-013-0358-z.
22. Chan LT, Freeda Siew Yuin Thean, Lucy Yeoh and Yeap PC. Stability of Extemporaneously Compounded Chloral Hydrate Oral Solution. Malaysian Journal of Pharmacy (MJP). 2018: 11-20https://mjpharm.org/stability-of-extemporaneously-compounded-chloral-hydrate-oral-solution/
23. Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak, Mahendra Singh Rathore. Stability Testing of Pharmaceutical Products. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(4): 317-8. doi: 10.52711/0975-4377.2021.00052
24. Pavithra Bodagala, Y Divya, C Parthiban, M Sudhakar. RP-HPLC Method Development and Validation for the Etonogestrel and Ethinyl Estradiol in Pharmaceutical Dosage form. Asian Journal of Pharmaceutical Analysis. 2024; 14(2): 76-0. doi: 10.52711/2231-5675.2024.00014.
25. Nuttapon Songnaka, Somchai Sawatdee, Apichart Atipairin. Stability-indicating HPLC Method for Determination of Naproxen in an Extemporaneous Suspension. Research J. Pharm. and Tech. 2018; 11(10): 4332-4338. doi: 10.5958/0974-360X.2018.00793.X
26. Raju TG, Ramya MG, Rajesh A, Kathirvel S, Gupta SK. ICH Guideline Practice- a Validated Stability- Indicating HPLC Method for the Determination of Efavirenz in Dosage Form. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 6(1): 7-14.
27. Sunanta Jeadkong, Somchai Sawatdee, Apichart Atipairin. Determination of Quinine Sulfate in Extemporaneous Suspension by Stability Indicating High Performance Liquid Chromatography. Research J. Pharm. and Tech. 2017; 10(6): 1603-1610. doi: 10.5958/0974-360X.2017.00282.7