Bucco-Adhesive Film as a Pediatric Proper Dosage Form for Systemic Delivery of Propranolol Hydrochloride: In-vitro and in-vivo Evaluation

References

• PatelVM, PrajapatiBG, PatelHV, PatelKM. Mucoadhesive bilayer tablets of propranolol hydrochloride. AAPS PharmSciTech. 2007;8:E203–E208. doi:10.1208/pt0803077
   Web of Science ®Google Scholar
• BialyLP, WojcikC, Mlynarczuk-BialyI. Mucosal delivery systems of antihypertensive drugs: A practicalapproach in general practice. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018;162:71–78. doi:10.5507/bp.2018.02229765168
   PubMed Web of Science ®Google Scholar
• PatelVM, PrajapatiBG, PatelMM. Formulation, evaluation, and comparison of billayered and multi-layered mucoadhesive buccal devices of propranolol hydrochloride. AAPS PharmSciTech. 2007;8:E147–E154. doi:10.1208/pt0801022
   Web of Science ®Google Scholar
• AbruzzoA, NicolettaFP, DalenaF, CerchiaraT, LuppiB, BigucciF. Bilayered buccal films as child-appropriate dosage form for systemic administration of propranolol. Int J Pharm. 2017;31(1):257–265. doi:10.1016/j.ijpharm.2017.08.070
   Web of Science ®Google Scholar
• AdhikariSNR, NayakBS, NayakAK, MohantyB. Formulation and evaluation of buccal patches for delivery of atenolol. AAPS PharmSciTech. 2010;11(3):1038–1044. doi:10.1208/s12249-010-9459-z20533098
   PubMed Web of Science ®Google Scholar
• ViralHS, PragnaS, GaurangBS. Design and evaluation of thiolated chitosan based mucoadhesive and permeation enhancing bilayered buccal drug delivery system. African J Pharm Pharmacol. 2012;6(7):491–501.
   Google Scholar
• LamJK, XuY, WorsleyA, WongIC. Oral transmucosal drug delivery for pediatric use. Adv Drug Deliv Rev. 2014;73:50–62. doi:10.1016/j.addr.2013.08.01123999459
   PubMed Web of Science ®Google Scholar
• PatelVF, LiuF, BrownMB. Advances in oral transmucosal drug delivery. J Control Release. 2011;153:106–116.21300115
   PubMed Web of Science ®Google Scholar
• BorgesAF, SilvaC, CoelhoJF, SimõesS. Oral films: current status and future perspectives. I-Galenical development and quality attributes. J Control Release. 2015;206:1–19.25747406
   PubMed Web of Science ®Google Scholar
• DixitRP, PuthliSP. Oral strip technology: overview and future potential. J Control Release. 2009;139:94–107. doi:10.1016/j.jconrel.2009.06.01419559740
   PubMed Web of Science ®Google Scholar
• TrastulloR, AbruzzoA, SaladiniB, et al. Design and evaluation of buccal films as paediatric dosage form for transmucosal delivery of ondansetron. Eur J Pharm Biopharm. 2016;105:115–121. doi:10.1016/j.ejpb.2016.05.02627267732
   PubMed Web of Science ®Google Scholar
• KrampeR, VisserJC, FrijlinkHW, BreitkreutzJ, WoerdenbagHJ, PreisM. Oromucosal film preparations: points to consider for patient centricity and manufacturing processes. Expert Opin Drug Deliv. 2016;13:493–506. doi:10.1517/17425247.2016.111804826559519
   PubMed Web of Science ®Google Scholar
• Salamat-MillerN, ChittchangM, JohnstonTP. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev. 2005;57:1666–1691. doi:10.1016/j.addr.2005.07.00316183164
   PubMed Web of Science ®Google Scholar
• MunasurAP, PillayV, ChettyDJ, GovenderT. Statistical optimisation of the mucoadhesivity and characterisation of multipolymeric propranolol matrices for buccal therapy. Int J Pharm. 2006;323:43–51. doi:10.1016/j.ijpharm.2006.05.05116863686
   PubMed Web of Science ®Google Scholar
• BansilR, TurnerBS. Mucin structure, aggregation, physiological functions and biomedical applications. Curr Opin Colloid Interface Sci. 2006;11:164–170. doi:10.1016/j.cocis.2005.11.001
   Web of Science ®Google Scholar
• ThirawongN, NunthanidJ, PuttipipatkhachornS, SriamornsakP. Mucoadhesive properties of various pectins on gastrointestinal mucosa: an in vitro evaluation using texture analyzer. Eur J Pharm Biopharm. 2007;67:132–140.17321731
   PubMed Web of Science ®Google Scholar
• ZargarV, AsghariM, DashtiA. A review on chitin and chitosan polymers: structure, chemistry, solubility, derivatives, and applications. ChemBioEng Rev. 2015;2:204–226.
   Web of Science ®Google Scholar
• SvenssonO, ArnebrantT. Mucin layers and multilayers—Physicochemical properties and applications. Curr Opin Colloid Interface Sci. 2010;15:395–405. doi:10.1016/j.cocis.2010.05.015
   Web of Science ®Google Scholar
• BuildersPF, KunleOO, OkpakuLC, BuildersMI, AttamaAA, AdikwuMU. Preparation and evaluation of mucinated sodium alginate microparticles for oral delivery of insulin. Eur J Pharm Biopharm. 2008;70:777–783. doi:10.1016/j.ejpb.2008.06.02118644444
   PubMed Web of Science ®Google Scholar
• CaoN, YangX, FuY. Effects of various plasticizers on mechanical and water vapor barrier properties of gelatin films. Food Hydrocoll. 2009;23(3):729–735. doi:10.1016/j.foodhyd.2008.07.017
   Web of Science ®Google Scholar
• MadhaviBR, MurthyVSN, RaniAP. Buccal film drug delivery system-an innovative and emerging technology. J Mol Pharm Org Process Res. 2013;1(3):2–6. doi:10.4172/2329-9053.1000107
   Google Scholar
• PatelMM, SmartJD, NevellTG, EwenRJ, EatonPJ, TsibouklisJ. Mucin/poly (acrylic acid) interactions: a spectroscopic investigation of mucoadhesion. Biomacromolecules. 2003;4(5):1184–1190.12959582
   PubMed Web of Science ®Google Scholar
• SemaltyM, SemaltyA, KumarG. Formulation and characterization of mucoadhesive buccal films of glipizide. PharmSci. 2008;73:43–48.
   Google Scholar
• MohamadSA, SarhanHA, AbdelkaderH, MansourHF. Vitamin B12-loaded buccoadhesive films as a non invasive supplement in vitamin B12 deficiency: in vitro evaluation and in vivo comparative study with intramuscular injection. J Pharm Sci. 2017;106:1849–1858. doi:10.1016/j.xphs.2017.03.04028400198
   PubMed Web of Science ®Google Scholar
• AvachatAM, GujarKN, WaghKV. Development and evaluation of tamarind seed xyloglucan-based mucoadhesive buccal films of rizatriptan benzoate. Carbohydr Polym. 2013;91(2):537–542. doi:10.1016/j.carbpol.2012.08.06223121942
   PubMed Web of Science ®Google Scholar
• ZengN, SeguinJ, DestruelP-L, et al. Cyanine derivative as a suitable marker for thermosensitive in situ gelling delivery systems: in vitro and in vivo validation of a sustained buccal drug delivery. Int J Pharm. 2017;534(12):128–135. doi:10.1016/j.ijpharm.2017.09.07328982548
   PubMed Web of Science ®Google Scholar
• AhnJ-S, ChoiH-K, ChunM-K, et al. Release of triamcinolone acetonide from mucoadhesive polymer composed of chitosan and poly (acrylic acid) in vitro. Biomaterials. 2002;23(6):1411–1416. doi:10.1016/S0142-9612(01)00261-711829436
   PubMed Web of Science ®Google Scholar
• TakkaS, RajbhandariS, SakrA. Effect of anionic polymers on the release of propranolol hydrochloride from matrix tablets. Eur J Pharm Biopharm. 2001;52(1):75–82. doi:10.1016/S0939-6411(01)00147-311438426
   PubMed Web of Science ®Google Scholar
• ShahVP, TsongY, SatheP, LiuJ. In vitro dissolution profile comparison, statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15:889–896. doi:10.1023/A:10119766157509647355
   PubMed Web of Science ®Google Scholar
• GibaldiM. Biopharmaceutics and Clinical Pharmacokinetics. 4th edition ed. Philadelphia, USA: Lea and Febiger; 1991.
   Google Scholar
• AinurofiqA, ChoiriS. Drug release model and kinetics of natural polymers-based sustained release tablet. Latin Am J Pharm. 2015;34:1328–1337.
   Web of Science ®Google Scholar
• HiguchiT. Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci. 1963;52(12):1145–1149. doi:10.1002/jps.260052121014088963
   PubMed Web of Science ®Google Scholar
• ChawlaV, TiwaryAK, GuptaS. Characterization of polyvinylalcohol microspheres of diclofenac sodium: application of statistical design. Drug Dev Ind Pharm. 2000;26:675–680. doi:10.1081/DDC-10010128310826116
   PubMed Web of Science ®Google Scholar
• PeppasNA, ColomboP. Analysis of drug release behaviour from swellable polymer carriers using the dimensionality index. J Control Release. 1997;45:35–40. doi:10.1016/S0168-3659(96)01542-8
   Web of Science ®Google Scholar
• TaylanB, CapanY, GüvenO, KesS, HincalAA. Design and evaluation of sustained-release and buccal adhesive propranolol hydrochloride tablets. J Control Release. 1996;38(1):11–20. doi:10.1016/0168-3659(95)00094-1
   Web of Science ®Google Scholar
• Food and Drug Administration. Center for Drug Evaluation and Research, Guidance for Industry, Bioanalytical Method Validation. USA; 2001.
   Google Scholar
• SahooJ, MurthyP, BiswalS, SahooS, MahapatraA. Comparative study of propranolol hydrochloride release from matrix tablets with Kollidon® SR or hydroxy propyl methyl cellulose. AAPS PharmSciTech. 2008;9(2):577–582. doi:10.1208/s12249-008-9092-218459050
   PubMed Web of Science ®Google Scholar
• SionkowskaA, WisniewskiM, SkopinskaJ, KennedyCJ, WessTJ. Molecular interactions in collagen and chitosan blends. Biomaterials. 2004;25(5):795–801.14609668
   PubMed Web of Science ®Google Scholar
• PalK, BanthiaAK, MajumdarDK. Preparation and characterization of polyvinyl alcohol-gelatin hydrogel membranes for biomedical applications. Aaps Pharmscitech. 2007;8(1):E142E146. doi:10.1208/pt080121
   Web of Science ®Google Scholar
• MohamadSA, AbdelkaderH, ElrehanyM, MansourHF. Vitamin B12 buccoadhesive tablets: auspicious non invasive substitute for intramuscular injection: formulation, in vitro and in vivo appraisal. Drug Dev Ind Pharm. 2019;45:244–251. doi:10.1080/03639045.2018.152978730289003
   PubMed Web of Science ®Google Scholar
• MacêdoR, Gomes Do NascimentoT, VerasJ. Compatibility and stability studies of propranolol hydrochloride binary mixtures and tablets for TG and DSC-photovisual. J Therm Anal Calorim. 2002;67(2):483–489. doi:10.1023/A:1013901332759
   Web of Science ®Google Scholar
• SatishbabuBK, SrinivasanBP. Preparation and evaluation of buccoadhesive films of atenolol. Indian J Pharm Sci. 2008;70:175–179. doi:10.4103/0250-474X.4145120046708
   PubMed Web of Science ®Google Scholar
• SudhakarY, KuotsuK, BandyopadhyayAK. Buccal bioadhesive drug delivery — A promising option for orally less efficient drugs. J Control Release. 2006;114(1):15–40. doi:10.1016/j.jconrel.2006.04.01216828915
   PubMed Web of Science ®Google Scholar
• GanjiF, VasheghaniFS, VasheghaniFE. Theoretical description of hydrogel swelling: a review. Iran Polym J. 2010;19(5):375–398.
   Web of Science ®Google Scholar
• PedacchiaA, AdroverA. Study of release kinetics and diffusion coefficients in swellable cellulosic thin films by means of a simple spectrophotometric technique. Chem Eng Res Des. 2014;92(11):2550–2556. doi:10.1016/j.cherd.2014.03.017
   Web of Science ®Google Scholar
• SrivastavaA, YadavT, SharmaS, NayakA, KumariA, MishraN. Polymers in drug delivery. JBM. 2016;4(01):69–84. doi:10.4236/jbm.2016.41009
   Google Scholar
• SinglaAK, ChawlaM, SinghA. Potential applications of carbomer in oral mucoadhesive controlled drug delivery system: a review. Drug Dev Ind Pharm. 2000;26(9):913–924. doi:10.1081/DDC-10010131810914315
   PubMed Web of Science ®Google Scholar
• GoodrichBF. The Science of Rheology: Pharmaceutically Applied, Technical Note (1992).
   Google Scholar
• OjaghSM, RezaeiM, RazaviSH, HosseiniSMH. Development and evaluation of a novel biodegradable film made from chitosan and cinnamon essential oil with low affinity toward water. Food Chem. 2010;122(1):161–166. doi:10.1016/j.foodchem.2010.02.033
   Web of Science ®Google Scholar
• JM SWY, LeuTL, YangMC. Evaluation of chitosan/PVA blended hydrogel membranes. J Memb Sci. 2004;236:39–51. doi:10.1016/j.memsci.2004.02.005
   Web of Science ®Google Scholar
• TejadaG, BarreraM, PiccirilliG, et al. Development and evaluation of buccal films based on chitosan for the potential treatment of oral candidiasis. AAPS PharmSciTech. 2017;18(4):936–946. doi:10.1208/s12249-017-0720-628108973
   PubMed Web of Science ®Google Scholar
• Bahri-NajafiR, TavakoliN, SenemarM, PeikanpourM. Preparation and pharmaceutical evaluation of glibenclamide slow release mucoadhesive buccal film. Res Pharm Sci. 2014;9(3):213–223.25657792
   PubMedGoogle Scholar
• MazzarinoL, BorsaliR, Lemos‐SennaE. Mucoadhesive films containing chitosan‐coated nanoparticles: A new strategy for buccal curcumin release. J Pharm Sci. 2014;103(11):3764–3771. doi:10.1002/jps.2414225187001
   PubMed Web of Science ®Google Scholar
• GiovinoC, AyensuI, TettehJ, BoatengJS. An integrated buccal delivery system combining chitosan films impregnated with peptide loaded PEG-b-PLA nanoparticles. Colloids Surf B Biointerfaces. 2013;112:9–15. doi:10.1016/j.colsurfb.2013.07.01923928054
   PubMed Web of Science ®Google Scholar
• BhiseK, DhumalR, ChauhanB, ParadkarA, KadamS. Effect of oppositely charged polymer and dissolution medium on swelling, erosion, and drug release from chitosan matrices. AAPS Pharmscitech. 2007;8(2):E110E118. doi:10.1208/pt080204418181531
   PubMed Web of Science ®Google Scholar
• KhanG, JiabiZ. Formulation and in vitro evaluation of ibuprofen-carbopol® 974P-NF controlled release matrix tablets III: influence of co-excipients on release rate of the drug. J Controlled Release. 1998;54(2):185–190. doi:10.1016/S0168-3659(97)00225-3
   PubMed Web of Science ®Google Scholar
• KumarA, BaliV, KumarM, PathakK. Comparative evaluation of porous versus nonporous mucoadhesive films as buccal delivery system of glibenclamide. AAPS PharmSciTech. 2013;14:1321–1332. doi:10.1208/s12249-013-0014-623990119
   PubMed Web of Science ®Google Scholar
• SheehanJ, OatesK, CarlstedtI. Electron microscopy of cervical, gastric and bronchial mucus glycoproteins. Biochemical j. 1986;239(1):147–153. doi:10.1042/bj2390147
   PubMed Web of Science ®Google Scholar
• DeaconMP, McGurkS, RobertsCJ, et al. Atomic force microscopy of gastric mucin and chitosan mucoadhesive systems. Biochem J. 2000;348(3):557–563. doi:10.1042/bj348055710839986
   PubMed Web of Science ®Google Scholar
• Yildiz PekozA, Sedef ErdalM, OkyarA, et al. Preparation and in-vivo evaluation of dimenhydrinate buccal mucoadhesive films with enhanced bioavailability. Drug Dev Ind Pharm. 2016;42:916–925. doi:10.3109/03639045.2015.109147026460061
   PubMed Web of Science ®Google Scholar
• KolandM, CharyuluRN, VijayanarayanaK, PrabhuP. In vitro and in vivo evaluation of chitosan buccal films of ondansetron hydrochloride. Int J Pharm Investig. 2011;1:64–71. doi:10.4103/2230-973X.85967
   PubMedGoogle Scholar
• Al-DhubiabBE. In vitro and in vivo evaluation of nano-based films for buccal delivery of zolpidem. Braz Oral Res. 2016;30:e126.27901207
   PubMed Web of Science ®Google Scholar
• WangY, WangZ, ZuoZ, et al. Clinical pharmacokinetics of buffered propranolol sublingual tablet (Promptol™)-application of a new “physiologically based” model to assess absorption and disposition. AAPS J. 2013;15:787–796. doi:10.1208/s12248-013-9479-123605805
   PubMed Web of Science ®Google Scholar
• DuchateauGSMJE, ZuidemaJ, MerkusFWHM. Bioavailability of propranolol after oral, sublingual, and intranasal administration. Pharm Res. 1986;3:108–111.24271469
   PubMed Web of Science ®Google Scholar
• Mansur AdeP, RamiresJA, AvakianSD, de PaulaRS, PileggiF. Comparison of the effects of diazepam, nifedipine, propranolol and a combination of nifedipine and propranolol, by sublingual administration, in patients with hypertensive crisis. Arq Bras Cardiol. 1991;7:313–317.
   Google Scholar