In Vitro, Ex Vivo and In Silico Mechanistic Elucidation of the Performance of an Optimized Porosity-Controlled Multi-Elemental Transbuccal System
Tóm tắt
To elucidate the mechanisms of construction and performance of a porosity controlled, multi-elemental transbuccal system employing experimental and computational approaches. The production of the formulation was guided through a Box-Benkhen design employing homogenization coupled with lyophilization. The physicochemical and physicomechanical properties of the experimental design formulations were quantified with relevant analytical techniques. The influence of changes in porosity measures on the magnitude of these physical properties were explored mathematically. Furthermore, experimental outputs from the Box-Behnken design formulations were fitted into set limits and optimized using the response surface method. The optimized porosity-controlled formulation was subjected to mechanistic experimental and computational elucidations. In general, the changes in magnitudes of studied porosity quantities had significant impact on formulation physicochemical and physicomechanical properties. The generation of an optimized formulation validated the stability and accuracy of the Box-Behnken experimental design. Experimental investigations revealed that the construction of this formulation is as a result of non-destructive physical interactions amongst its make-up compounds while its mechanism of performance is anchored mainly upon a gradual collapse of its ordered porous structure. Furthermore, the molecule mechanics simulations quantitatively predicted the molecular interactions inherent to multicomponent matrix formation and the mucoadhesion mechanism. The fabrication and performance mechanisms of the porosity-controlled transbuccal system was successfully explored.
Tài liệu tham khảo
Mehta KA, Kislalioglu MS, Phuapradit W, Malick AW, Shah NH. Effect of formulation and process variables on porosity parameters and release rates from a multi-unit erosion matrix of a poorly soluble drug. J Control Release. 2000;63(1–2):201–11.
Popovici RF, Seftel EM, Mihai GD, Popovici E, Voicu VA. Controlled drug delivery system based on ordered mesoporous silica matrices of captopril as Angiotensin-Converting Enzyme inhibitor drug. J Pharm Sci. 2011;100(2):704–14.
Tai H, Mather ML, Howard D, Wang W, White LJ, Crowe JA, et al. Control of pore size and structure of tissue engineering scaffolds produced by supercritical fluid processing. Eur Cells Mater. 2007;14:64–77.
Ginty PJ, Barry JJA, White LJ, Howdle SM, Shakesheff KM. Controlling protein release from scaffolds using polymer blends and composite. Eur J Pharm Biopharm. 2008;68(1):82–9.
Grinberg O, Binderman I, Bahar H, Ziberman M. Highly porous bioresorbable scaffolds with controlled release of bioactive agents for tissue-regeneration applications. Acta Biomaterial. 2010;6(4):1278–87.
Hawkins AM, Milbrandt TA, Puleo DA, Hilt JZ. Composite hydrogel scaffolds with controlled pore opening via biodegradable hydrogel porogen degradation. J Biomed Mater Res A. 2014;102(2):400–12.
Qi X-N, Mou Z-L, Zhang J, Zhang Z-Q. Preparation of chitosan/silk fibroin/hydroxyapatite porous scaffold and its characteristics in comparison to bi-component scaffolds. J Biomed Mater Res A. 2014;102(2):366–72.
Aerts CA, Veeraedt E, Depla A, Follens L, Froyen L, Van Humbeeck J, et al. Potential of amorphous microporous silica for ibuprofen controlled release. Int J Pharm. 2010;397(1–2):84–91.
Makhija SN, Vavia PR. Controlled porosity osmotic pump-based controlled release systems of pseudoephedrine. I. Cellulose acetate as a semi-permeable membrane. J Control Release. 2003;89(1):5–18.
Liu H, Yang X-G, Nie S-F, Wei L-L, Zhou L-L, Liu H, et al. Chitosan-based controlled porosity osmotic pump for colon-specific delivery system: Screening of formulation variables and in vitro investigation. Int J Pharm. 2007;332(1–2):115–24.
Kumaravelrajan R, Narayanan N, Suba V. Development and evaluation of controlled porosity osmotic pump for Nifedipine and Metoprolol combination. Lipids Health Dis. 2011;10(51):1–13.
Adibkia K, Ghanbarzadeh S, Shokri MH, Arami Z, Arash Z, Shokri JT. Micro-porous surfaces in controlled drug delivery systems: design and evaluation of diltiazem hydrochloride controlled porosity osmotic pump using non-ionic surfactants as pore-former. Pharm Dev Technol. 2014;19(4):507–12.
Lin WJ, Lee HK, Wang DM. The influence of plasticizers on the release of theophylline from microporous-controlled tablets. J Control Release. 2004;99(3):415–21.
Mishira M, Mishira B. Design and evaluation of microporous membrane coated matrix tablets for a highly water soluble drug. Chem Pharm Bull. 2010;58(7):995–1000.
Park HS, Kim CW, Lee HJ, Choi JH, Lee SG, Yun Y-P, et al. A mesoporous silica nanoparticle with charge-convertible pore walls for efficient intracellular protein delivery. Nanotechnology. 2010;21(22):1–9.
Zhang Y, Zhi Z, Jiang T, Zhang J, Wang Z, Wang S. Spherical mesoporous silica nanoparticles for loading and release of poorly water-soluble drug telmisartan. J Control Release. 2010;145(3):257–63.
Yang Y-J, Tao X, Hou Q, Chen J-F. Fluorescent mesoporous silica nanotubes incorporating CdS quantum dots for controlled release of ibuprofen. Acta Biomater. 2009;5(9):3488–96.
Kim MS, Seo KS, Hyun H, Kim SK, Khang G, Lee HB. Sustained release of bovine serum albumin using implantable wafers prepared by MPEG-PLGA diblock copolymers. Int J Pharm. 2005;304(1–2):165–77.
Verraedt E, Braem A, Chaudhari A, Thevissen K, Adams E, Van Mellasrt L, et al. Controlled release of chlorhexidine antiseptic from microporous amorphous silica applied in open porosity of an implant surface. Int J Pharm. 2011;419(1–2):28–32.
Espanol M, Perez RA, Montufar EB, Marichal C, Sacco A, Ginebra WP. Intrinsic porosity of calcium phosphate cements and its significance for drug delivery and tissue engineering applications. Acta Biomater. 2009;5(7):2752–62.
Hong M-H, Son J-S, Kim K-M, Han M, Oh DS, Lee Y-K. Drug-loaded porous spherical hydroxyapatite granules for bone regeneration. J Mater Sci-Mater M. 2011;22(2):349–55.
Sotthivirat S, Haslam JL, Lee PI, Rao VM, Stella VJ. Release mechanisms of a sparingly water-soluble drug from controlled porosity-osmotic pump pellets using Sulfobutylether-β-Cyclodextrin as both a solubilizing and osmotic agent. J Pharm Sci. 2009;98(6):1992–2000.
Ilyas S, Gal S. Optical devices from porous silicon having continuously varying refractive index. J Mater Sci-Mater El. 2007;18:S61–4.
Webb PA, Orr C. Analytical methods in fine particle technology. Texas: Norcross, Micromeritics Instrument Corporation; 1997.
Adeleke OA, Pillay V, du Toit LC, Choonara YE. Construction and in vitro characterization of an optimized porosity-enabled amalgamated matrix for sustained transbuccal drug delivery. Int J Pharm. 2010;391(1–2):79–89.
Aguilar-de-Leyva A, Cifuentes C, Rajabi-Siahboomi AR, Caraballo I. Study of the critical points and the role of pores and viscosity in carbamazepine hydrophilic matrix tablets. Eur J Pharm Biopharm. 2012;80(1):136–42.
Sher P, Ingavle G, Ponrathnam S, Poddar P, Pawar AP. Modulation and optimization of drug release from uncoated low density porous carrier based delivery system. AAPS PharmSciTech. 2009;10(2):547–58.
Hoa MLK, Lu M, Zhang Y. Preparations of porous materials with ordered hole structure. Adv Colloid Interfac. 2006;121(1–3):9–23.
Yu H-D, Tee SY, Han M-Y. Preparation of porosity-controlled calcium carbonate by thermal decomposition of volume content-variable calcium carboxylate derivatives. Chem Commun. 2013;49(39):4229–31.
Sudhakar Y, Kuotsu K, Bandyopadhyay AK. Buccal bioadhesive drug delivery- a promising option for orally less efficient drugs. J Control Release. 2006;114(1):15–40.
Smart JD. The basics and underlying mechanisms of mucoadhesion. Adv Drug Deliver Rev. 2005;57(11):1556–68.
Peh KK, Wong CF. Polymeric films as vehicle for buccal delivery: swelling, mechanical and bioadhesive properties. J Pharm Sci. 1999;2(2):53–61.
Pillay V, Fassihi R. Evaluation and comparison of dissolution data derived from different modified release dosage forms: An alternative method. J Control Release. 1998;55(1):45–55.
Ansari M, Kazemipour M, Talebria J. The development and validation of a dissolution method for clomipramine solid dosage forms. Dissol Technol. 2004;August:16–24.
Van Eyk AD, der Bijl V. Comparative permeability of various chemical markers through human vaginal and buccal mucosa as well as porcine buccal and mouth floor mucosa. Arch Oral Biol. 2004;49(5):387–92.
Giannola LI, De Caro V, Giandalia G, Siragusa MG, Tripodo C, Florena AM, et al. Release of naltrexone on buccal mucosa: Permeation studies, histological aspects and matrix system design. Eur J Pharm Biopharm. 2007;67(2):425–33.
Minghetti P, Cilurzo F, Casiraghi A, Montanari L, Fini A. Ex vivo study of transdermal permeation of four diclofenac salts from different vehicles. J Pharm Sci. 2007;96(4):814–23.
Kolawole OA, Pillay V, Choonara YE. Novel polyamide 6,10 variants synthesized by modified interfacial polymerization for application as a rate-modulated monolithic drug delivery system. J Bioact Compat Pol. 2007;22(3):281–313.
Kumar P, Pillay V, Choonara YE, Modi G, Naidoo D, du Toit LC. In silico theoretical molecular modeling for Alzheimer’s disease: The nicotine-Curcumin paradigm in neuroprotection and neurotherapy. Int J Mol Sci. 2011;12:694–724.
Silverstein RM, Bassler GC, Morril TC. Spectrometric identification of organic compounds. New York: Wiley; 1991.
Taylor LS, Zografi G. Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersions. Pharm Res. 1997;14(12):1691–8.
Sethia S, Squillante E. Solid dispersions of carbamazepine in PVP K30 by conventional solvent evaporation and supercritical methods. Int J Pharm. 2004;272(1–2):1–10.
Yu BY, Chung JW, Kwak SY. Reduced Migration from Flexible Poly(vinyl chloride) of a Plasticizer Containing β-Cyclodextrin Derivative. Environ Sci Technol. 2008;42:7522–7.