STABILITY OF ZOLEDRONATE GEL EMULSION IN VIRGIN COCONUT OIL
Keywords:Zoledronate, Drug stability, Virgin coconut oil, Orthodontic tooth movement
Objective: This study aimed to analyze the physical stability and drug content of zoledronate (ZOL) gel emulsion in virgin coconut oil (VCO) as a new
pharmaceutical product at 25°C as room temperature and 40°C as an accelerated temperature for a stability physics test.
Methods: The ZOL gel emulsion comprises the following ingredients: 0.16% ZOL powder, 2% carboxymethyl cellulose, 5% VCO, 0.44% sodium
benzoate, and 0.009% antioxidant butylated hydroxytoluene, and distilled water. Samples of this gel emulsion were stored for 1 month at 25°C and
40°C, and the parameters used for stability tests were pH, viscosity, spreadability, and adhesive strength. The drug content was also evaluated with a
spectrophotometer. The ZOL gel emulsion was evaluated against these metrics on days 1, 7, 14, and 28.
Results: The results showed that ZOL pH, viscosity, spreadability, adhesive strength, and drug content gel emulsion were clinically stable over 28 days
of storage at 25°C, whereas it was not stable when stored at 40°C for the same duration. pH value of ZOL gel emulsion significantly decreased at 28 days
(p<0.05). Also for viscosity, adhesive strength, and drug content of ZOL gel emulsion showed statistically significant (p<0.05), except for spreadability
value (p>0.05). The spreadability value between ZOL gel emulsion that stored at 25°C and at 40°C showed no significant result at 7 and 14 days (p>0.05).
Conclusion: ZOL gel emulsion was stable at 25°C when stored for 28 days, suggesting that this is a suitable storage temperature at which its physical
stability and drug content can be maintained.
application of zoledronate for maximum anchorage during space
closure. Am J Orthod Dentofacial Orthop 2012;142:780-91.
2. Al-Awadhi EA, Garvey TM, Alhag M, Claffey NM, O’Connell B.
Efficacy of the nance appliance as an anchorage-reinforcement method.
Am J Orthod Dentofacial Orthop 2015;147:330-8.
3. Papageorgiou SN, Kutschera E, Memmert S, Gölz L, Jäger A,
Bourauel C, et al. Effectiveness of early orthopaedic treatment with
headgear: A systematic review and meta-analysis. Eur J Orthod 2017;
4. Bos A, Kleverlaan CJ, Hoogstraten J, Prahl-Andersen B, Kuitert R.
Comparing subjective and objective measures of headgear compliance.
Am J Orthod Dentofacial Orthop 2007;132:801-5.
5. Reynders R, Ronchi L, Bipat S. Mini-implants in orthodontics:
A systematic review of the literature. Am J Orthod Dentofacial Orthop 2009;
6. Antoszewska-Smith J, Sarul M, ?yczek J, Konopka T,
Kawala B. Effectiveness of orthodontic miniscrew implants in anchorage
reinforcement during en-masse retraction: A systematic review and
meta-analysis. Am J Orthod Dentofacial Orthop 2017;151:440-55.
7. Zahrowski JJ. Bisphosphonate treatment: An orthodontic concern
calling for a proactive approach. Am J Orthod Dentofacial Orthop 2007;
8. Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level
reactions to orthodontic force. Am J Orthod Dentofacial Orthop 2006;
9. Graham JW. Bisphosphonates and orthodontics: Clinical implications.
J Clin Orthod 2006;7:425-8.
10. Adachi H, Igarashi K, Mitani H, Shinoda H. Effects of topical
administration of a bisphosphonate (risedronate) on orthodontic tooth
movements in rats. J Dent Res 1994;73:1478-86.
11. Kim TW, Yoshida Y, Yokoya K, Sasaki T. An ultrastructural study
of the effects of bisphosphonate administration on osteoclastic bone
resorption during relapse of experimentally moved rat molars. Am J
Orthod Dentofacial Orthop 1999;115:645-53.
12. Liu L, Igarashi K, Haruyama N, Saeki S, Shinoda H, Mitani H,
et al. Effects of local administration of clodronate on orthodontic tooth
movement and root resorption in rats. Eur J Orthod 2004;26:469-73.
13. Parlina C, Purwaningsih E, Jusuf A, Widayati R. Impact of zoledronate
bisphosphonates gel in virgin coconut oil on the increase of apoptosis
osteoclast. Int J Appl Pharm 2017;9:24-7.
14. Sanjeewani NA, Sakeena MH. Formulation and characterization of
virgin coconut oil (VCO) based emulsion. Int J Sci Res Publ 2013;3:2?7.
15. Bajaj S, Singla D, Sakhuja N. Stability testing of pharmaceutical
products. J Appl Pharm Sci 2012;2:129-38.
16. Meenakshi D. Emulgel: A novel approach to topical drug delivery. Int J
Pharm Biol Sci 2013;4:847-56.
17. Vats S, Saxena C, Easwari TS, Shukla VK. Emulsion based gel
technique: Novel approach for enhancing topical drug delivery of
hydrophobic drugs. Int J Pharm Res Sch. 2014;3:649-59.
18. Ajazuddin, Alexander A, Khichariya A, Gupta S, Patel RJ, Giri TK,
et al. Recent expansions in an emergent novel drug delivery technology:
Emulgel. J Control Release 2013;171:122-32.
19. Hayatullina Z, Muhammad N, Mohamed N, Soelaiman IN. Virgin
coconut oil supplementation prevents bone loss in osteoporosis rat
model. Evid Based Complement Alternat Med 2012;2012:237236.
20. Rowe R, Sheskey P, Quinn M. Handbook of Pharmaceutical Excipients.
6th ed. London: RPS Publishing; 2009.
21. Iradhati AH, Jufri M. Formulation and physical stability test of
griseofulvin micremulsion gel. Int J Appl Pharm 2017;1:7-10.
22. Aslani A, Zolfaghari B, Davoodvandi F. Design, formulation and
evaluation of an oral gel from Punica granatum flower extract for the
treatment of recurrent aphthous stomatitis. Adv Pharm Bull 2016;6:391?8.
23. Lee SK, Anema S, Klostermeyer H. The influence of moisture content
on the rheological properties of processed cheese spreads. Int J Food
Sci Technol 2016;39:763-71.
24. Sayuti NA. Formulation and physical Sstability of Cassia alata L. leaf
extract gel. J Kefarmasian Indones 2015;5:74-82.
25. Owen DH, Peters JJ, Lavine ML, Katz DF. Effect of temperature and
pH on contraceptive gel viscosity. Contraception 2003;67:57-64.
26. Park NA, Irvine TF Jr. Anomalous viscosity-temperature behavior of
aqueous carbopol solutions. J Rheol 2003;41:167-73.
27. Wijayanto BA, Kurniawan DW, Sobri I. Formulation and effectiveness
of antiseptic hand gel preparations containing galanga essential oils
(Alpinia galanga (L) Willd.)). J Ilmu Kefarmasian Indones. 2013;
28. Riski R, Umar AH, Rismadani DP. Emulgel antiinflamation from extract
of temulawak (Curcuma xanthorrhiza Roxb). J Pharm Med Sci 2016;
29. Sirisoontorn I, Hotokezaka H, Hashimoto M, Gonzales C,
Luppanapornlarp S, Darendeliler MA, et al. Orthodontic tooth
movement and root resorption in ovariectomized rats treated by
systemic administration of zoledronic acid. Am J Orthod Dentofacial
30. Lin J. Bisphosphonates: A review of their pharmacokinetic properties.
31. Keles A, Grunes B, Difuria C, Gagari E, Srinivasan V, Darendeliler MA,
et al. Inhibition of tooth movement by osteoprotegerin vs. Pamidronate
under conditions of constant orthodontic force. Eur J Oral Sci 2007;