Volume : 09, Issue : 08, August – 2022

Title:

47.FORMULATION AND EVALUATION OF SUBLINGUAL TABLETS OF POORLY SOLUBLE DRUG ATORVASTATIN USING SUPERDISINTEGRANTS

Authors :

Tabassum Fatima*, Niranjan Panda, Abikesh Prasada Kumar Mahapatra, Syed Safiullah Ghori

Abstract :

Atorvastatin belongs to the group of medications known as HMG-CoA reductase inhibitors (statins). Sublingual tablets, which disintegrate in the oral cavity beneath the tongue in less than a minute, are solid dosage forms that have the benefit of avoiding first pass metabolism. The need for Sublingual has increased over the past ten years, particularly among the elderly and kids who have swallowing issues. In order to achieve rapid disintegration in gastric pH and quick action to lower cholesterol and triglyceride (fat) levels in the blood, the current study’s goal was to create sublingual tablets of atorvastatin using various concentrations of starch (soluble), AC-Di-Sol and polyplasdone-XL as superdisintegrants. There are twelve different Atorvastatin Sublingual tablet formulations that were created using wet granulation technology. There is no interaction between the medications and the numerous excipients employed in the formulation, according to FTIR technology studies on the compatibility of drugs and excipients. When compared to the pharmacopoeia, the outcomes of the various precompression and after compression characterizations of tablets were satisfactory. Using a USP II paddle type dissolution equipment, in vitro release experiments for a number of formulations were carried out. Formulation AST11, which contains 2% AC-Di-Sol and 4% Polyplasdone-XL, demonstrated complete drug release in less than 30 minutes (>99%), establishing itself as an optimised formulation. Using both superdisintegrants in tandem also demonstrated an improved drug release profile. However, when compared to the commonly marketed formulation, the formulation AST8 with 4% Polyplasdone-XL exhibits the highest similarity factor and the lowest difference factor; therefore, it is regarded as the best formulation from the perspective of the dissolving profile. The zero-order kinetic model was the best formulation. Accelerated stability studies for improved formulation were done to confirm the stability of dose forms.
Key words: Atorvastatin, Sublingual tablet, AC-Di-Sol, Polyplasdone- XL, anticholesteremic.

Cite This Article:

Please cite this article in press Tabassum Fatima et al, Formulation And Evaluation Of Sublingual Tablets Of Poorly Soluble Drug Atorvastatin Using Superdisintegrants., Indo Am. J. P. Sci, 2022; 09(8).

,

Number of Downloads : 10

References:

1. Prajapati ST, Patel MV, Patel CN. Preparation and evaluation of sublingual tablets of zolmitriptan. Int J Pharma Investig 2014;4:27-31.
2. Narang N, Sharma J. Sublingual mucosa as a route for syste mic drug delivery. Int J Pharm Pharm Sci 2011;3:18-22.
3. Kurosaki Y, Takatori T, Nishimura H, Nakayama T, Kimura T. Regional variation in oral mucosal drug absorption: Permeability and degree of keratinization in hamster oral cavity. Pharm Res 1991;8:1297-301
4. Czeisler JL, Perlman KP. Dil uents. In: Swarbrick TJ, Boylan JC, editors. Encyclopedia of Pharmaceutical Technology. New York, NY: Marcel Dekker Inc.; 1991. p. 37-83.
5. Pusapati RT, Kumar MK, Rapeti SS, Murthy T. Development of co-processed excipients in the design and evaluation of atorvastatin calcium tablets by direct compression method. Int J Pharma Investig 2014;4:102-6.
6. Biradar SS, Bhagavati ST, Kuppasad IJ. Fast dissolving drug delivery systems: A brief overview. International Journal of Pharmaceutical Sciences, 2006; 4(2).
7. Wael Ali, Alia A. Badawi, Mahmoud A. Mahdy, Hanan M. El-Nahas, Formulation and evaluation of carbamazepine 200mg immediate release tablets using polyethylene glycol 6000, Int J Pharm Pharm Sci, 2013, 5 (l):114-119.
8. Md Sarfaraz, V.G.Joshi, Immediate release solid oral dosage form of salbutamol sulphate:design, optimization and evaluation, Int J Pharm Pharm Sci, 2013, 5 (4): 610-618.
9. Siddiqui MN, Garg G., Sharma PK. Fast Dissolving Tablets: Preparation, Characterization and Evaluation: An Overview, International Journal of Current Pharmaceutical Research, 2008, 15(4).
10. Niranjan Panda, Afshan Sultana, A Venkateswar Reddy, G. V. Subba Reddy, M.S.Ansari: Formulation Design and Study the effect of Polyplasdone-XL and AC-Di-Sol on Release Profile of Doxofylline Immediate Release Tablets. Int. J. Pharm. Sci. Rev. Res., 32(2), 2015: 67-76.
11. Dalia Abd Elaty Mostafa. Formulation and evaluation of Chlorophenoxamine hydrochloride rapidly disintegrating tablets, Int, Res, J. Pharma. 2014; 5(10): 765-769.
12. M. Akbar, N. Panda, AV Reddy, “Formulation and Evaluation of Doxofylline Sublingual Tablets Using Sodium Starch Glycolate and Crosscarmellose Sodium as Superdisintegrant” Int. J. of Pharm. Res. & All. Sci. 2015; 4(2):90-100.
13. Sudhir. Maddela, Eswar Gupta. Maddi and Ramarao. Nadendla, Immediate Release Formulation of Valsartan Capsule and Evaluation of its Compatibility by Nonthermal Methods, American Journal of Advanced Drug Delivery, 1 (3), 2013, 180-196.
14. Patel DM, Patel SP, Patel CN. Formulation and evaluation of fast dissolving tablet containing Domperidone ternary solid dispersion. Int J Pharma Investig 2014;4:174-82.
15. Rao NG, Munde MR. Formulation and in-vitro evaluation of mucoadhesive buccal fi lms of zolmitriptan. J Pharm Res 2011;4:2682-5.
16. Subedi RK, Ryoo JP, Moon C, Choi HK. Infl uence of formulation variables in transdermal drug delivery system containing zolmitriptan. Int J Pharm 2011;419:209-14.
17. Bhardwaj V, Shukla V, Goyal N, Salim MD, Sharma PK. Formulation and evaluation of fast disintegrating sublingual tablets of amlodipine besylate using different superdisintegrants. Int J Pharm Sci 2010;2:89-2.
18. Balusu H, Reddy P. Formulation and evaluation of fast disintegrating zolmitriptan sublingual tablets. Curr Trends Biotechnol Pharm 2012;6:84-98.
19. Mahmoud AA, Salah S. Fast relief from migraine attacks using fast-disintegrating sublingual zolmitriptan tablets. Drug Dev Ind Pharm 2012;38:762-9.
20. Roden DM, Antiarrhythmic Drugs, In: Goodman and Gilman’s Pharmacology Basis of Therapeutics, 10th ed., McGraw Hill Publishing Division, New York 2006, 949-50.
21. Koteswari P, Sunium S, Srinivasababu P, Babu GK, Nithya PD. Formulation Development and evaluation of fast disintegrating tablets of Lamotrigine using liqui-solid technique. Int J Pharma Investig 2014;4:207-14.
22. Naik PS., Kurup NS. Design and optimization of fast dissolving tablets containing metoprolol by sublimation method. IRJP.2010;1(1): 346-357.
23. Md Sarfaraz, V.G.Joshi, Immediate release solid oral dosage form of salbutamol sulphate:design, optimization and evaluation, International Journal of Pharmacy and Pharmaceutical sciences, 2013, 5 (4): 610-618.
24. Leon Lachmann , Herbert A , Liberman , Joseph L.Kaing , The theory and practice of Industrial Pharmacy:293-303.
25. Aulton`s Pharmaceutics, The design & manufacture of medicines, Biopharmaceutics and pharmacokinetics, A Treatise, second edition, Valabh Prakashan, 315-84.
26. Shirwaikar R., Shirwaikar A., Prabu L., Mahalaxmi R., Rajendran K., Kumar C. Studies of superdisintegrant properties of seed mucilage of Ocimum gratissimum. Indian Journal of Pharmaceutical sciences. 2007; 69(6): 753-758.
27. Palkhede M., Amrutkar S., Erande K.. Formulation, optimization and evaluation of fast disintegrating tablet of mebeverine HCl. Int J Pharm Pharm Sci. 2012; 4(4):121-125.
28. S. Agarwal, P. V. K Kumari, Y.S Rao, formulation, evaluation and comparision of dissolution profiles of Eslicarbazepine acetate immediate release tablets using natural binders against synthetic binder, International Journal of Pharmacy and Pharmaceutical sciences, 2013, 5 (4):192-194.