Formulation of sustained release bioadhesive minitablets containing solid dispersion of levofloxacin for once daily ocular use

References

• Abdelbary G. 2011. Ocular ciprofloxacin hydrochloride mucoadhesive chitosan-coated liposomes. Pharm Dev Technol. 16:44–56.
   PubMed Web of Science ®Google Scholar
• Adeyeye CM, Rowley J, Madu D, Javadi M, Sabnis SS. 1995. Evaluation of crystallinity and drug release stability of directly compressed theophylline hydrophilic matrix tablets stored under varied moisture conditions. Int J Pharm. 116:65–75.
   Web of Science ®Google Scholar
• Ali J, Khar R, Ahuja A, Kalra R. 2002. Buccoadhesive erodible disk for treatment of oro-dental infections: design and characterisation. Int J Pharm. 238:93–103.
   PubMed Web of Science ®Google Scholar
• Andrews GP, Laverty TP, Jones DS. 2009. Mucoadhesive polymeric platforms for controlled drug delivery. Eur J Pharm Biopharm. 71:505–518.
   PubMed Web of Science ®Google Scholar
• Araújo AA, Storpirtis S, Mercuri LP, Carvalho FM, dos Santos Filho MS, Matos JR. 2003. Thermal analysis of the antiretroviral zidovudine (AZT) and evaluation of the compatibility with excipients used in solid dosage forms. Int J Pharm. 260:303–314.
   PubMed Web of Science ®Google Scholar
• Aulton ME, Taylor K. 2017. Aulton’s pharmaceutics: the design and manufacture of medicines. 5th ed. New York (NY): Elsevier Health Sciences.
   Google Scholar
• Bamiro OA, Ubale RV, Addo RT. 2016. Background of ocular drug delivery. In: Addo RT, editor. Ocular drug delivery: advances, challenges and applications. Cham, Switzerland: Springer International Publishing; p. 1–9.
   Google Scholar
• Barzegar-Jalali M, Alaei-Beirami M, Javadzadeh Y, Mohammadi G, Hamidi A, Andalib S, Adibkia K. 2012. Comparison of physicochemical characteristics and drug release of diclofenac sodium–eudragit® RS100 nanoparticles and solid dispersions. Powder Technol. 219:211–216.
   Web of Science ®Google Scholar
• Bhagav P, Trivedi V, Shah D, Chandran S. 2011. Sustained release ocular inserts of brimonidine tartrate for better treatment in open-angle glaucoma. Drug Deliv Transl Res. 1:161–174.
   PubMed Web of Science ®Google Scholar
• Botha SA, Lötter AP. 1990. Compatibility study between naproxen and tablet excipients using differential scanning calorimetry. Drug Dev Ind Pharm. 16:673–683.
   Web of Science ®Google Scholar
• Bozdag S, Weyenberg W, Adriaens E, Dhondt MMM, Vergote V, Vervaet C, De Prijck K, Nelis HJ, De Spiegeleer B, Ludwig A, et al. 2010. In vitro evaluation of gentamicin- and vancomycin-containing minitablets as a replacement for fortified eye drops. Drug Dev Ind Pharm. 36:1259–1270.
   PubMed Web of Science ®Google Scholar
• Bruschi ML. 2015. Strategies to modify the drug release from pharmaceutical systems. Amsterdam, Netherlands: Elsevier Science.
   Google Scholar
• Cai J, Zhang Y, Du W, Nan K. 2011. Preparation and in vitro release of spray-dried chitosan microspheres for levofloxacin delivery. J Control Release. 152:e70–e71.
   PubMed Web of Science ®Google Scholar
• CARAS. 2012. Stability study of levofloxacin 750 mg/30 ml IV vials. Cairo, Egypt: Center of Applied Research and Advanced Studies (CARAS), Faculty of Pharmacy, Cairo University.
   Google Scholar
• Chen X, Ooi CP. 2008. Hydrolytic degradation and drug release properties of ganciclovir-loaded biodegradable microspheres. Acta Biomater. 4(4):1046–1056.
   Google Scholar
• Chopra S, Patil GV, Motwani SK. 2007. Release modulating hydrophilic matrix systems of losartan potassium: optimization of formulation using statistical experimental design. Eur J Pharm Biopharm. 66:73–82.
   PubMed Web of Science ®Google Scholar
• Cides LCS, Araújo AAS, Santos-Filho M, Matos JR. 2006. Thermal behaviour, compatibility study and decomposition kinetics of glimepiride under isothermal and non-isothermal conditions. J Therm Anal Calorim. 84:441–445.
   Web of Science ®Google Scholar
• Cohen S, Lobel E, Trevgoda A, Peled Y. 1997. A novel in situ-forming ophthalmic drug delivery system from alginates undergoing gelation in the eye. J Controlled Release. 44:201–208.
   Web of Science ®Google Scholar
• Cook MT, Khutoryanskiy VV. 2015. Mucoadhesion and mucosa-mimetic materials-A mini-review. Int J Pharm. 495:991–998.
   PubMed Web of Science ®Google Scholar
• Deshpande PB, Dandagi P, Udupa N, Gopal SV, Jain SS, Vasanth SG. 2010. Controlled release polymeric ocular delivery of acyclovir. Pharm Dev Technol. 15:369–378.
   PubMed Web of Science ®Google Scholar
• Dolenc A, Kristl J, Baumgartner S, Planinšek O. 2009. Advantages of celecoxib nanosuspension formulation and transformation into tablets. Int J Pharm. 376:204–212.
   PubMed Web of Science ®Google Scholar
• Draize JH, Woodard G, Calvery HO. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol Exp Ther. 82:377–390.
   Web of Science ®Google Scholar
• Duxfield L, Sultana R, Wang R, Englebretsen V, Deo S, Rupenthal ID, Al-Kassas R. 2016. Ocular delivery systems for topical application of anti-infective agents. Drug Dev Ind Pharm. 42:1–11.
   PubMed Web of Science ®Google Scholar
• El-Samaligy MS, Yahia SA, Basalious EB. 2004. Formulation and evaluation of diclofenac sodium buccoadhesive discs. Int J Pharm. 286:27–39.
   PubMed Web of Science ®Google Scholar
• El-Zahaby SA, Kassem AA, El-Kamel AH. 2014. Design and evaluation of gastroretentive levofloxacin floating mini-tablets-in-capsule system for eradication of Helicobacter pylori. Saudi Pharm J. 22:570–579.
   PubMed Web of Science ®Google Scholar
• French DL, Himmelstein KJ, Mauger JW. 1995. Physicochemical aspects of controlled release of substituted benzoic and naphthoic acids from Carbopol® gels. J Controlled Release. 37:281–289.
   Web of Science ®Google Scholar
• Gorle AP, Gattani SG. 2010. Development and evaluation of ocular drug delivery system. Pharm Dev Technol. 15:46–52.
   PubMed Web of Science ®Google Scholar
• Gorman EM, Samas B, Munson EJ. 2012. Understanding the dehydration of levofloxacin hemihydrate. J Pharm Sci. 101:3319–3330.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Madan S, Majumdar DK, Maitra A. 2000. Ketorolac entrapped in polymeric micelles: preparation, characterisation and ocular anti-inflammatory studies. Int J Pharm. 209:1–14.
   PubMed Web of Science ®Google Scholar
• Gupta H, Aqil M, Khar RK, Ali A, Bhatnagar A, Mittal G. 2011. Biodegradable levofloxacin nanoparticles for sustained ocular drug delivery. J Drug Target. 19:409–417.
   PubMed Web of Science ®Google Scholar
• Gupta H, Aqil M, Khar RK, Ali A, Bhatnagar A, Mittal G. 2015. An alternative in situ gel-formulation of levofloxacin eye drops for prolong ocular retention. J Pharm Bioallied Sci. 7:9–14.
   PubMed Web of Science ®Google Scholar
• Hamzah MM, Reem KA, Ahmad AN, Othman AHA. 2010. Effect of different biological membranes on in vitro bioadhesion property. Drug Invent Today. 2:155–159.
   Google Scholar
• Horoz BB, Kiliçarslan M, Yüksel N, Baykara T. 2006. Influence of aluminum tristearate and sucrose stearate as the dispersing agents on physical properties and release characteristics of Eudragit RS microspheres. AAPS PharmSciTech. 7:E111–E117.
   PubMed Web of Science ®Google Scholar
• ICH. 2003. Stability testing of new drug substances and products Q1A (R2). Geneva, Switzerland: ICH.
   Google Scholar
• Joshi BV, Patil VB, Pokharkar VB. 2002. Compatibility studies between carbamazepine and tablet excipients using thermal and non-thermal methods. Drug Dev Ind Pharm. 28:687–694.
   PubMed Web of Science ®Google Scholar
• Katara R, Sachdeva S, Majumdar DK. 2018. Design, characterization, and evaluation of aceclofenac-loaded Eudragit RS 100 nanoparticulate system for ocular delivery. Pharm Dev Technol. 1–12.
   Web of Science ®Google Scholar
• Kawakami S, Nishida K, Mukai T, Yamamura K, Nakamura J, Sakaeda T, Nakashima M, Sasaki H. 2001. Controlled release and ocular absorption of tilisolol utilizing ophthalmic insert-incorporated lipophilic prodrugs. J Control Release. 76:255–263.
   PubMed Web of Science ®Google Scholar
• Khan GM, Zhu JB. 1999. Studies on drug release kinetics from ibuprofen-carbomer hydrophilic matrix tablets: influence of co-excipients on release rate of the drug. J Control Release. 57:197–203.
   PubMed Web of Science ®Google Scholar
• Kubova K, Peček D, Hasserová K, Doležel P, Pavelková M, Vyslouzil J, Muselík J, Vetchy D. 2017. The influence of thermal treatment and type of insoluble poly(meth)acrylates on dissolution behavior of very soluble drug from hypromellose matrix tablets evaluated by multivariate data analysis. Pharm Dev Technol. 22:206–217.
   PubMed Web of Science ®Google Scholar
• Lin SY, Yu HL. 1999. Thermal stability of methacrylic acid copolymers of Eudragits L, S, and L30D and the acrylic acid polymer of carbopol. J Polym Sci A Polym Chem. 37:2061–2067.
   Web of Science ®Google Scholar
• Ludwig A. 2005. The use of mucoadhesive polymers in ocular drug delivery. Adv Drug Deliv Rev. 57:1595–1639.
   PubMed Web of Science ®Google Scholar
• Manjappa AS, Nanjwade BK, Manvi FV, Murthy R. 2009. Sustained ophthalmic in situ gel of ketorolac tromethamine: rheology and in vivo studies. Drug Dev Res. 70:417–424.
   Web of Science ®Google Scholar
• Mathurm M, Gilhotra RM. 2011. Glycerogelatin-based ocular inserts of aceclofenac: physicochemical, drug release studies and efficacy against prostaglandin E2-induced ocular inflammation. Drug Deliv. 18:54–64.
   PubMed Web of Science ®Google Scholar
• McGinity JW, Cameron CG, Cuff GW. 1983. Controlled-release theophylline tablet formulations containing acrylic resins. I. Dissolution properties of tablets. Drug Dev Ind Pharm. 9:57–68.
   Web of Science ®Google Scholar
• Mohamed MI, Haider M, Ali MM. 2011. Buccal mucoadhesive films containing antihypertensive drug: in vitro/in vivo evaluation. J Chem Pharm Res. 3:665–686.
   Google Scholar
• Moore JW, Flanner HH. 1996. Mathematical comparison of dissolution profiles. Pharm Technol. 20:64–74.
   Google Scholar
• Moosa RM, Choonara YE, du Toit LC, Kumar P, Carmichael T, Tomar LK, Tyagi C, Pillay V. 2014. A review of topically administered mini-tablets for drug delivery to the anterior segment of the eye. J Pharm Pharmacol. 66:490–506.
   PubMed Web of Science ®Google Scholar
• Mora PC, Cirri M, Mura P. 2006. Differential scanning calorimetry as a screening technique in compatibility studies of DHEA extended release formulations. J Pharm Biomed Anal. 42:3–10.
   PubMed Web of Science ®Google Scholar
• Mura P, Gratteri P, Faucci MT. 2002. Compatibility studies of multicomponent tablet formulations: DSC and experimental mixture design. J Therm Anal Calorim. 68:541–551.
   Web of Science ®Google Scholar
• Nokhodchi A, Okwudarue ON, Valizadeh H, Momin MN. 2009. Cogrinding as a tool to produce sustained release behavior for theophylline particles containing magnesium stearate. AAPS PharmSciTech. 10:1243–1251.
   PubMed Web of Science ®Google Scholar
• Pang X, Li J, Pi J, Qi D, Guo P, Li N, Wu Y, Liu Z. 2018. Increasing efficacy and reducing systemic absorption of brimonidine tartrate ophthalmic gels in rabbits. Pharm Dev Technol. 23:231–239.
   PubMed Web of Science ®Google Scholar
• Patel VM, Prajapati BG, Patel MM. 2007. Effect of hydrophilic polymers on buccoadhesive Eudragit patches of propranolol hydrochloride using factorial design. AAPS PharmSciTech. 8:E119–E126.
   PubMed Web of Science ®Google Scholar
• Pawar P, Katara R, Majumdar D. 2012. Design and evaluation of moxifloxacin hydrochloride ocular inserts. Acta Pharm. 62:93.
   PubMed Web of Science ®Google Scholar
• Pawar P, Katara R, Mishra S, Majumdar DK. 2013. Topical ocular delivery of fluoroquinolones. Expert Opin Drug Deliv. 10:691–711.
   PubMed Web of Science ®Google Scholar
• Refai H, Tag R. 2011. Development and characterization of sponge-like acyclovir ocular minitablets. Drug Deliv. 18:38–45.
   PubMed Web of Science ®Google Scholar
• Ritger PL, Peppas NA. 1987a. A simple equation for description of solute release I. Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or discs. J Control Release. 5:23–36.
   Google Scholar
• Ritger PL, Peppas NA. 1987b. A simple equation for description of solute release II. Fickian and anomalous release from swellable devices. J Control Release. 5:37–42.
   Google Scholar
• Robinson JR, Mlynek GM. 1995. Bioadhesive and phase-change polymers for ocular drug delivery. Adv Drug Del Rev. 16:45–50.
   Web of Science ®Google Scholar
• Rowe RC, Sheskey PJ, Quinn ME, Association AP. 2009. Handbook of pharmaceutical excipients. London: Pharmaceutical Press.
   Google Scholar
• Saher O, Ghorab DM, Mursi NM. 2016. Preparation and in vitro/in vivo evaluation of antimicrobial ocular in situ gels containing a disappearing preservative for topical treatment of bacterial conjunctivitis. Pharm Dev Technol. 21:600–610.
   PubMed Web of Science ®Google Scholar
• Salamat-Miller N, Chittchang M, Johnston TP. 2005. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev. 57:1666–1691.
   PubMed Web of Science ®Google Scholar
• Shiledar RR, Tagalpallewar AA, Kokare CR. 2014. Formulation and in vitro evaluation of xanthan gum-based bilayered mucoadhesive buccal patches of zolmitriptan. Carbohydr Polym. 101:1234–1242.
   PubMed Web of Science ®Google Scholar
• Shukla S, Bajpai AK, Bajpai J. 2003. Swelling controlled delivery of antibiotic from a hydrophilic macromolecular matrix with hydrophobic moieties. Macromol Res. 11:273–282.
   Web of Science ®Google Scholar
• Singla AK, Chawla M, Singh A. 2000. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev Ind Pharm. 26:913–924.
   PubMed Web of Science ®Google Scholar
• Smart JD. 2005. The basics and underlying mechanisms of mucoadhesion. Adv Drug Deliv Rev. 57:1556–1568.
   PubMed Web of Science ®Google Scholar
• Solomonidou D, Cremer K, Krumme M, Kreuter J. 2001. Effect of carbomer concentration and degree of neutralization on the mucoadhesive properties of polymer films. J Biomater Sci Polym Ed. 12:1191–1205.
   PubMed Web of Science ®Google Scholar
• Test No. 405: Acute Eye Irritation/Corrosion. 2017. OECD guidelines for the testing of chemicals, section 4. Paris, France: Organisation for Economic Cooperation and Development (OECD).
   Google Scholar
• Thumma S, Majumdar S, ElSohly MA, Gul W, Repka MA. 2008. Chemical stability and bioadhesive properties of an ester prodrug of Δ(9)-tetrahydrocannabinol in poly (ethylene oxide) matrices: effect of formulation additives. Int J Pharm. 362:126–132.
   PubMed Web of Science ®Google Scholar
• Varshosaz J, Faghihian H, Rastgoo K. 2006. Preparation and characterization of metoprolol controlled-release solid dispersions. Drug Deliv. 13:295–302.
   PubMed Web of Science ®Google Scholar
• Verma RK, Garg S. 2005. Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility testing. J Pharm Biomed Anal. 38:633–644.
   PubMed Web of Science ®Google Scholar
• Yavuz B, Kompella UB. 2017. Ocular drug delivery. In: Whitcup SM, Azar DT, editors. Pharmacologic therapy of ocular disease. Cham, Switzerland: Springer International Publishing; p. 57–93.
   Google Scholar