Central Composite Design for the Development of Trimetazidine Dihydrochloride-Loaded Fast Dissolving Film
Yıl 2023,
, 61 - 74, 01.03.2023
Swapnil Chopade
,
Santosh A. Payghan
Öz
A fast-dissolving dosage form is an approach used to improve therapeutic efficacy and bioavailability by avoiding the first-pass metabolism of the cargo. Besides, the approach causes rapid cargo absorption from the pre-gastric area which may outcome in the quick inception of action. The trimetazidine dihydrochloride (TDC) is an anti-anginal drug and there is a prerequisite to provide fast onset of action to treat angina. Therefore, the present work was aimed to prepare and evaluate fast-dissolving oral films (FDOF) of TDC to provide fast onset of action. The FDOF is prepared by using the solvent casting method and it was optimized by employing a central composite statistical design. The two independent variables such as HPMC K4M and PEG 400 are the film-forming polymers which are evaluated at three levels. The dependent variables selected as folding endurance, disintegration time, and % drug release. The formulation was prepared and optimized the batch F-4 showed the least disintegration time (19 s) and the highest drug release (98.55±7.90%). Moreover, the ex-vivo mucus permeation study showed better permeation and satisfying physicochemical properties. As per the above results, we conclude that the prepared formulation could be a novel dosage form to improve drug delivery and patient compliance.
Kaynakça
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Yıl 2023,
, 61 - 74, 01.03.2023
Swapnil Chopade
,
Santosh A. Payghan
Kaynakça
- Reference1 Al-Ani IH, Shakya AK, Hassan SF. Design, Optimization, and Evaluation of Combined Dosage form of Amoxicillin and Nonsteroidal Anti-inflammatory Agent for Pediatric use using DoE. Asian J of Pharm. 2019; 13(2): 125-130.
- Reference2 Ahn H. Central Composite Design for the Experiments with Replicate Runs at Factorial and Axial Points. Industrial Engineering, Management Science and Applications 2015: 969-970.
- Reference3 Balaa R, Sharmab S. Formulation optimization and evaluation of fast dissolving film of aprepitant by using design of experiment. Bull Fac Pharm Cairo Univ. 2018; 56: 159–168.
- Reference4 Binfeng X, Zhen Y, Haiying Z, Viera L, Wei Z, Mikolaj M, and Filippos K, et al. Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem. AAPS J. 2015; 17(3): 631–642.
- Reference5 Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J. 2013; 21(2): 201–213.
- Reference6 Chaudhary H, Gauri S, Rathee P, Kumar V. Development and optimization of fast dissolving oro-dispersible films of granisetron HCl using Box–Behnken statistical design, Bull Fac Pharm Cairo Univ. 2013; 51: 193–201.
- Reference7 Deswati S, Izzati R, Hamzar S, Zein R and Alif A. Application of central composite design for optimization the determination of lead using adsorptive cathodic stripping voltammetry. Rasayan J Chem. 2016; 9(1): 8 – 17.
- Reference8 Dezsi CA. Trimetazidine in Practice: Review of the Clinical and Experimental Evidence. Am J. Ther. 2016; 23(3):871–879.
- Reference9 Irfan M, Rabel S, Bukhtar Q, Imran Qadir MI, Jabeen F, Khan A, et al. Orally disintegrating films: A modern expansion in drug delivery system. Saudi Pharm. J. 2016; 24: 537-546.
- Reference10 Ittadwar PA, Bhojne SV and Puranik PK. Novel salicin phytosomal complex: development and optimization using central composite design. World J. Pharm. Res. 2018; l7 (9):735-751.
- Reference11 Karki S, Kim H, Jeong Na S, Shin D, Jo K, Lee J, et al. Thin films as an emerging platform for drug delivery, Asian J Pharm. Sci. 2016; 11:559-574.
- Reference12 Khabade SS, Chopade SS, Gaikwad ER, Payghan SA. Potential Screening of Spray Dried Solid Dispersion of Orlistat using Three Dimensional Solubility Parameter. Asian J. of Pharm, (Suppl). 2017; 11(4):760-766.
- Reference13 Maheswari KM, Devineni PK, Deekonda S, Shaik S, Uppala NP, and Nalluri BN, et al. Development and evaluation of mouth dissolving films of amlodipine besylate for enhanced therapeutic efficacy. J Pharm (Cairo). 2014: 1-10.
- Reference14 Navamanisubramaniana R, Nerellaa R, Duraipandianb C, Seetharamanc S. Quality by design approach for optimization of epaglinide buccal tablets using Box-Behnken Design. Future J of Pharm Sci. 2018; 4: 265-272.
- Reference15 Pethe AM and Desai RB. Formulation, Optimization & evaluation of mouth dissolving film of nifedipine by using design of experiment. Asian J. of Pharm Sci. 2016; 11: 74-76.
- Reference16 Priyanka P, Rikisha L, Mayur C and Ujjaval S. Development and Optimization of Fast Dissolving Orodispersible Film of Baclofen Using 32 Central Composite Design. Int J Pharm Sci. 2014; 5(12): 5539-47.
- Reference17 Shimoda H, Taniguchi K, Nishimura M, Matsuura K, Tsukioka T, Yamashita H, et al. Preparation of a fast dissolving oral thin film containing dexamethasone: A possible application to antiemesis during cancer chemotherapy. Euro J. of Pharm and Biopharm. 2009; 73: 361-365.
- Reference18 Singh B, Dahiya M, Saharan V, Ahuja NU. Optimizing drug delivery systems using systematic design of experiments. Part II: retrospect and prospects. Crit Rev Ther Drug Carrier Syst. 2005; 22(3):215-293.
- Reference19 Sadhukhan B, Mondal NK, Chattoraj S. Optimisation using central composite design (CCD) and the desirability function for sorption of methylene blue from aqueous solution onto Lemna major. Karbala International Journal of Modern Science 2; 2016:145-155.
- Reference20 Tomar A, Sharma K, Chauhan N, Mittal A, Bajaj U. Formulation and evaluation of fast dissolving oral film of dicyclomine as potential route of buccal delivery. Int. J Drug Dev & Res. 2012; 4(2): 408-417.
- Reference21 Xin T, Zhao Y, Jing H, Zhang W, Gao Y, Yang X, et al. A time-released osmotic pump fabricated by compression-coated method: Formulation screen, mechanism research and pharmacokinetic study. Asian J. of Pharm Sci. 2014; 9: 208-217.
- Reference22 Izhar SA, Ahmed AM and Arief M. Formulation and Characterization of Mucoadhesive Buccal Films of Trimetazidine Dihydrochloride, Lat. Am. J. Pharm. 34 (8): (2015):1585-93.
- Reference23 Kunte S, Tandale P. Fast dissolving strips: A novel approach for the delivery of verapamil. J Pharm Bio all. Sci. 2010; 4: 325-8.
- Reference24 Semalty M, Semalty A, Kumar G, Juyal V. Development of mucoadhesive buccal films of glipizide. Int. J. of Pharm. Sci & Nano. 1(2); 2008: 184-190.
- Reference25 Dandagi P, Singh A, Manvi F, Belekar A. Formulation of trimetazidine matrix tablet using methocel and effect of different parameters on drug release from matrix tablet. Turk J. Pharm Sci 10 (2); 2013: 287-302.