MC

Current Trends in Science and Technology

an Open Access Publication ISSN: 0976-9730 | 0976-9498

Medical

FORMULATION AND CHARACTERIZATION OF SALBTAMOL AND MONTELUKAST SODIUM BILAYERED TABLET BY USING DIRECT COMPRESSION METHOD.

Ramesh Ingole
Sunrise University ,Alwar Pharmacy College,Alwar.,Rajasthan ,India
Jayesh Dwivedi
Sunrise University ,Alwar Pharmacy College,Alwar.,Rajasthan ,India
G Jeyabalan
Sunrise University ,Alwar Pharmacy College,Alwar.,Rajasthan ,India
Mrunal K.Shirsath
Sunrise University ,Alwar Pharmacy College,Alwar.,Rajasthan ,India
Online First: December 22, 2018
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Abstract

Abstract


The present research work aimed to formulate  sustained and immediate release bi- layer  tablet of Salbutamol sulphate (Bronchodilator Beta2 agonist), Montelukast sodium Leukotriene receptor antagonist)   with desired sustained release  properties, desired drug release rate, local action in stomach , Showing other Pharmacological activities and prevention of side effect. The different formulation by using polymers like Carbopol-934P, HPMC E50 LV, Mannitol, Talc and Aspartame .Formulations of sustained and immediate release bi- layer  tablet of Salbutamol sulphate Montelukast Ms1 to Ms14  are developed by direct compression method are evaluated for physical parameters,  hardness, thickness, weight variation, drug content and in vitro drug release rate. Furthermore, FTIR spectroscopic studies were performed to determine drug polymer interaction. The formulation is optimized on the basis of in-vitro drug release. Performing evaluation parameters like weight variation, thickness, hardness and friability.


All formulations passed the USP requirements. Research is carried out, based on understanding the asthma symptoms and its attack to the patients (early morning), to provide the alternative therapy and reduce the frequency with combination therapy to come out of the asthma symptoms by dual mechanism of action by administration of dosage form through oralcavity  having an in vitro mucosal residence time of at least 6 to 8 hours and in vitro release profile of both sustained release layer and immediate release layer as per pharmacokinetic requirement.

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Feb 7, 2020
Published
Dec 22, 2018
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References

1. Dal Negra, R., Turco, P., Pomari, C., and Trevisan, F., Calcitonin nasal spray in patienmts with chronic asthma: a double-blind crossover study vs placebo, Int. J. Clin. Pharmacol. Ther. Toxicol., 29:144-146,1991. 2. Jain NK. Controlled and novel drug delivery.2nd ed. New Delhi: CBS Publisher and distributer;2002. 3. Aungst, B.J., Rogers, N.J., and Shefter, E., Comparison of nasal, rectal, buccal, sublingual and intramuscular insulin efficacy and the effects of a bile salt absorption promoter, The J. Pharmacol. Exp. Ther., 244:23-27, 1988. 4. Aungst, B.J. and Rogers, N.J., Site dependence of absorption-promoting actions of Laureth-9, Na salicylate, Na2EDTA, and Aprotinin on rectal, nasal, and buccal insulin delivery, Pharm. Res., 5:305-308,1988. 5. Lee, W.E., Permeation enhancers for the nasal delivery of protein and peptide therapeutics, Bio Pharm, 3:22-25, 1990. 6. Tengamnuay, P. and Mitra, A.K., Bile salt-fatty acid mixed micelles as nasal absorption promoters of peptides. I. Effects of ionic strength. adjuvant composition, and lipid structure on the nasal absorption of [D- Arg2]Kyotorphin, Pharm. Res., 7:127-133, 1990. 7. Shao, Z. and Mitra, A.K., Nasal membrane and intracellular protein and enzyme release by bile salts and bile salt-fatty acid mixed micelles: correlation with facilitated drug transport, Pharm. Res., 9:1992,1992. 8. Shao, Z. and Mitra, A.K., Bile salt fatty acid mixed micelles as nasal absorption promoters. III. Effects on nasal transport and enzymatic degradation of acyclovir prodrugs, Pharm. Res., 11:243-250,1994. 9. Soyani, A.P. and Chien, Y.W., Systemic delivery of peptides and proteins across absorptive mucosae, Crit. Rev. Therap. Drug Carrier Systems, 13:85-184,1996. 10. Adjei, A., Sundberg, D., Miller, J., and Chun, A., Bioavailability of leuprolide acetate following nasal inhalation delivery to rats and healthy humans, Pharm. Res., 9:244-249,1992. 11. Shimamoto, T., Pharmaceutical aspects. Nasal and depot formulations of leuprolide, J. Androl., 8:S14-S16,1987. 12. Dal Negra, R., Turco, P., Pomari, C., and Trevisan, F., Calcitonin nasal spray in patienmts with chronic asthma: a double-blind crossover study vs placebo, Int. J. Clin. Pharmacol. Ther. Toxicol., 29:144-146,1991. 13. Plosker, G.L. and McTavish, D., Intranasal salcatonin (salmon calcitonin). A review of its pharmacological properties and role in the management of postmenopausal osteoporosis, Drugs Aging, 8:378-400, 1996. 14. Reginster, J.Y. and Lecart, M.P., Efficacy and safety of drugs for Paget's disease of bone, Bone, 17:485S-488S,1995. 15. Berlin CM.Alternative routes of drug administration –Advantage and disadvantage (Subject Review). Pediatrics 1997;100(1):143-150. 16. Zhang H, Zhang J, Streisand J. Oral mucosal drug delivery-clinical pharmacokinetics and therapeutics application. ClinPharmacokinet 2002; 41(9):661-80. 17. NHLBI Guideline2007, pp. 11–12.http://en.wikipedia.org/wiki/Asthma# CITERE FNHLBI_ Guideline2007. (Downloaded on01/08/2012). 18. Squier, C.A., The permeability of oral mucosa, Crit. Rev. Oral Biol. Med., 2:13-32,1991. 19. . GINA 2009, p.2 20. Tippets B, Guilbert TW (2009). "Managing Asthma in Children: Part 1: Making the Diagnosis, Assessing Severity". Consultant for Pediatricians 8 (5).http://www.consultantlive.com/asthma/article/10162/1414747. 21. Miyazaki S, Kawasaki N, Nakamura T, Iwatsu M, Hayashi T, Hou WM, Attwood D. Oral mucosal bioadhesive tablets of pectin and HPMC: in vitro and in vivo evaluation. Int J Pharm 2000; 204:127–32. 22. Martin L, Wilson CG, Koosha F, UchegbuIF. Sustained buccal delivery of the hydrophobic drug denbufylline using physically cross-linked palmitoyl glycol chitosan hydrogels. Eur J Pharm Biopharm 2003; 55: 35–45. 23. Nafee NA, Isamail FA, Boraie NA, Mortada LM. Mucoadhesive delivery systems. Formulation and in vitro/in –vivo evaluation of buccal mucoadhesive tablets containing water soluble drugs. Drug DevInd Pharm 2004; 30(9):995-1004. 24. Singh B, Ahuja N. Development of controlled release bucoadhesive hydrophilic matrices of diltiazem hydrochloride: Optimization of bioadhesion, dissolution, and diffusion parameters. Drug DevInd Pharm 2002;28(4):431-42. 25. Martin A, Bustamante P, Chun AHC. Physical Pharmacy. 4th ed. New Delhi: B.I.WaverlyPvt Ltd;1999. 26. Higuchi WI. Diffusion models useful in biopharmaceutics-drug release rate processes. J Pharm Sci 1967; 56 (3):315-24. 27. PeppasNA,RitgerPL.Asimpleequationfordescriptionofsoluterelease II. Fickian and anomalous release from swellable devices. J Control Release. 1987; 5 (1):37-42.
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References

1. Dal Negra, R., Turco, P., Pomari, C., and Trevisan, F., Calcitonin nasal spray in patienmts with chronic asthma: a double-blind crossover study vs placebo, Int. J. Clin. Pharmacol. Ther. Toxicol., 29:144-146,1991.
2. Jain NK. Controlled and novel drug delivery.2nd ed. New Delhi: CBS Publisher and distributer;2002.
3. Aungst, B.J., Rogers, N.J., and Shefter, E., Comparison of nasal, rectal, buccal, sublingual and intramuscular insulin efficacy and the effects of a bile salt absorption promoter, The J. Pharmacol. Exp. Ther., 244:23-27, 1988.
4. Aungst, B.J. and Rogers, N.J., Site dependence of absorption-promoting actions of Laureth-9, Na salicylate, Na2EDTA, and Aprotinin on rectal, nasal, and buccal insulin delivery, Pharm. Res., 5:305-308,1988.
5. Lee, W.E., Permeation enhancers for the nasal delivery of protein and peptide therapeutics, Bio Pharm, 3:22-25, 1990.
6. Tengamnuay, P. and Mitra, A.K., Bile salt-fatty acid mixed micelles as nasal absorption promoters of peptides. I. Effects of ionic strength. adjuvant composition, and lipid structure on the nasal absorption of [D- Arg2]Kyotorphin, Pharm. Res., 7:127-133, 1990.
7. Shao, Z. and Mitra, A.K., Nasal membrane and intracellular protein and enzyme release by bile salts and bile salt-fatty acid mixed micelles: correlation with facilitated drug transport, Pharm. Res., 9:1992,1992.
8. Shao, Z. and Mitra, A.K., Bile salt fatty acid mixed micelles as nasal absorption promoters. III. Effects on nasal transport and enzymatic degradation of acyclovir prodrugs, Pharm. Res., 11:243-250,1994.
9. Soyani, A.P. and Chien, Y.W., Systemic delivery of peptides and proteins across absorptive mucosae, Crit. Rev. Therap. Drug Carrier Systems, 13:85-184,1996.
10. Adjei, A., Sundberg, D., Miller, J., and Chun, A., Bioavailability of leuprolide acetate following nasal inhalation delivery to rats and healthy humans, Pharm. Res., 9:244-249,1992.
11. Shimamoto, T., Pharmaceutical aspects. Nasal and depot formulations of leuprolide, J. Androl., 8:S14-S16,1987.
12. Dal Negra, R., Turco, P., Pomari, C., and Trevisan, F., Calcitonin nasal spray in patienmts with chronic asthma: a double-blind crossover study vs placebo, Int. J. Clin. Pharmacol. Ther. Toxicol., 29:144-146,1991.
13. Plosker, G.L. and McTavish, D., Intranasal salcatonin (salmon calcitonin). A review of its pharmacological properties and role in the management of postmenopausal osteoporosis, Drugs Aging, 8:378-400, 1996.
14. Reginster, J.Y. and Lecart, M.P., Efficacy and safety of drugs for Paget's disease of bone, Bone, 17:485S-488S,1995.
15. Berlin CM.Alternative routes of drug administration –Advantage and disadvantage (Subject Review). Pediatrics 1997;100(1):143-150.
16. Zhang H, Zhang J, Streisand J. Oral mucosal drug delivery-clinical pharmacokinetics and therapeutics application. ClinPharmacokinet 2002; 41(9):661-80.
17. NHLBI Guideline2007, pp. 11–12.http://en.wikipedia.org/wiki/Asthma# CITERE FNHLBI_ Guideline2007. (Downloaded on01/08/2012).
18. Squier, C.A., The permeability of oral mucosa, Crit. Rev. Oral Biol. Med., 2:13-32,1991.
19. . GINA 2009, p.2
20. Tippets B, Guilbert TW (2009). "Managing Asthma in Children: Part 1: Making the Diagnosis, Assessing Severity". Consultant for Pediatricians 8 (5).http://www.consultantlive.com/asthma/article/10162/1414747.
21. Miyazaki S, Kawasaki N, Nakamura T, Iwatsu M, Hayashi T, Hou WM, Attwood D. Oral mucosal bioadhesive tablets of pectin and HPMC: in vitro and in vivo evaluation. Int J Pharm 2000; 204:127–32.
22. Martin L, Wilson CG, Koosha F, UchegbuIF. Sustained buccal delivery of the hydrophobic drug denbufylline using physically cross-linked palmitoyl glycol chitosan hydrogels. Eur J Pharm Biopharm 2003; 55: 35–45.
23. Nafee NA, Isamail FA, Boraie NA, Mortada LM. Mucoadhesive delivery systems. Formulation and in vitro/in –vivo evaluation of buccal mucoadhesive tablets containing water soluble drugs. Drug DevInd Pharm 2004; 30(9):995-1004.
24. Singh B, Ahuja N. Development of controlled release bucoadhesive hydrophilic matrices of diltiazem hydrochloride: Optimization of bioadhesion, dissolution, and diffusion parameters. Drug DevInd Pharm 2002;28(4):431-42.
25. Martin A, Bustamante P, Chun AHC. Physical Pharmacy. 4th ed. New Delhi: B.I.WaverlyPvt Ltd;1999.
26. Higuchi WI. Diffusion models useful in biopharmaceutics-drug release rate processes. J Pharm Sci 1967; 56 (3):315-24.
27. PeppasNA,RitgerPL.Asimpleequationfordescriptionofsoluterelease
II. Fickian and anomalous release from swellable devices. J Control Release. 1987; 5 (1):37-42.
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