Implementation and in vitro characterization of calcium-free in situ gelling oral reconstituted suspension for potential overweight treatment

References

• Joint WHO/FAO expert consultation on diet, nutrition and the prevention of chronic diseases. Geneve: WHO; 2003.
   Google Scholar
• Rahmouni K , Correia MLG , Haynes WG , et al. Obesity-associated hypertension: new insights into mechanisms. Hypertension. 2005;45(1):9–14.
   PubMed Web of Science ®Google Scholar
• Hossain P , Kawar B , Nahas ME. Obesity and diabetes in the developing world—a growing challenge. N Engl J Med. 2007;356:213–215.
   PubMed Web of Science ®Google Scholar
• Kurth T , Gaziano JM , Berger K , et al. Body mass index and the risk of stroke in men. Arch Intern Med. 2002;162(22):2557–2562.
   PubMed Web of Science ®Google Scholar
• Schlienger J-L , Luca F , Vinzio S , et al. [Obesity and cancer]. Rev Med Interne. 2009;30(9):776–782.
   PubMed Web of Science ®Google Scholar
• Tan BH , Birdsell LA , Martin L , et al. Sarcopenia in an overweight or obese patient is an adverse prognostic factor in pancreatic cancer. Clin Cancer Res. 2009;15:6973–6979. CCR-09-1525.
   PubMed Web of Science ®Google Scholar
• Kang JG , Park C-Y. Anti-obesity drugs: a review about their effects and safety. Diabetes Metab J. 2012;36(1):13–25.
   PubMedGoogle Scholar
• Wan-Loy C , Siew-Moi P. Marine algae as a potential source for anti-obesity agents. Mar Drugs. 2016;14(12):222.
   Web of Science ®Google Scholar
• Point V , Bénarouche A , Zarrillo J , et al. Slowing down fat digestion and absorption by an oxadiazolone inhibitor targeting selectively gastric lipolysis. Eur J Med Chem. 2016;123:834–848.
   PubMed Web of Science ®Google Scholar
• Pellegrinelli V , Carobbio S , Vidal-Puig A. Adipose tissue plasticity: how fat depots respond differently to pathophysiological cues. Diabetologia. 2016;59(6):1075–1088.
   PubMed Web of Science ®Google Scholar
• Krentz AJ , Fujioka K , Hompesch M. Evolution of pharmacological obesity treatments: focus on adverse side-effect profiles. Diabetes Obes Metab. 2016;18(6):558–570.
   PubMed Web of Science ®Google Scholar
• Padwal RS , Majumdar SR. Drug treatments for obesity: orlistat, sibutramine, and rimonabant. Lancet (London, England). 2007;369(9555):71–77.
   PubMed Web of Science ®Google Scholar
• Castel A. L'orlistat dosé à 60 mg, ALLI®, premier médicament en vente libre pour traiter le surpoids et l'obésité. Sciences pharmaceutiques. 2012;(1):137.
   Google Scholar
• Pelkman CL , Navia JL , Miller AE , et al. Novel calcium-gelled, alginate-pectin beverage reduced energy intake in nondieting overweight and obese women: interactions with dietary restraint status. Am J Clin Nutr. 2007;86(6):1595–1602.
   PubMed Web of Science ®Google Scholar
• Deneva MG , Yadid-Pecht O , Fattouche M , et al. Utilization of temporary controllable intragastric pseudobezoars for the treatment of obesity. Curr Obes Rep. 2012;1(2):68–74.
   Google Scholar
• Greenway FL , Aronne LJ , Raben A , et al. A randomized, double-blind, placebo-controlled study of gelesis100: a novel nonsystemic oral hydrogel for weight loss. Obesity (Silver Spring). 2019;27(2):205–216.
   PubMed Web of Science ®Google Scholar
• Dettmar PW , Strugala V , Craig Richardson J. The key role alginates play in health. Food Hydrocolloids. 2011;25(2):263–266.
   Web of Science ®Google Scholar
• Hoad C , Rayment P , Cox E , et al. Investigation of alginate beads for gastro-intestinal functionality, part 2: in vivo characterisation. Food Hydrocolloids. 2009;23(3):833–839.
   Web of Science ®Google Scholar
• Guidon C. Hypercalcémies sévères. EMC - Anesthésie-Réanimation. 2005;2(2):114–131.
   Google Scholar
• Ziegler R. Hypercalcemic crisis. J Am Soc Nephrol. 2001;12(suppl 1):S3–S9.
   PubMed Web of Science ®Google Scholar
• Desmeules J. Interactions des médicaments avec l'alimentation. PHARMA-FLASH. 2002;29(05):17–21.
   Google Scholar
• Berger J , Reist M , Mayer JM , et al. Structure and interactions in chitosan hydrogels formed by complexation or aggregation for biomedical applications. Eur J Pharm Biopharm. 2004;57(1):35–52.
   PubMed Web of Science ®Google Scholar
• Patil J , Kamalapur MV , Marapur SC , et al. Ionotropic gelation and polyelectrolyte complexation: the novel techniques to design hydrogel particulate sustained, modulated drug delivery system: a review. Digest J Nanomater Biostruct. 2010;5(1):241–248.
   Web of Science ®Google Scholar
• Mucha M. Rheological characteristics of semi‐dilute chitosan solutions. Macromol Chem Phys. 1997;198(2):471–484.
   Web of Science ®Google Scholar
• Gyles DA , Castro LD , Silva JOC , et al. A review of the designs and prominent biomedical advances of natural and synthetic hydrogel formulations. Eur Polym J. 2017;88:373–392.
   Web of Science ®Google Scholar
• Park Y , Kim M-H , Park S-C , et al. Investigation of the antifungal activity and mechanism of action of LMWS-chitosan. J Microbiol Biotechnol. 2008;18(10):1729–1734.
   PubMed Web of Science ®Google Scholar
• Goy RC , Morais STB , Assis OBG. Evaluation of the antimicrobial activity of chitosan and its quaternized derivative on E. coli and S. aureus growth. Revista Brasileira de Farmacognosia. 2016;26(1):122–127.
   Google Scholar
• Schreiber SB , Bozell JJ , Hayes DG , et al. Introduction of primary antioxidant activity to chitosan for application as a multifunctional food packaging material. Food Hydrocolloids. 2013;33(2):207–214.
   Web of Science ®Google Scholar
• Ueno H , Mori T , Fujinaga T. Topical formulations and wound healing applications of chitosan. Adv Drug Deliv Rev. 2001;52(2):105–115.
   PubMed Web of Science ®Google Scholar
• Kulig D , Zimoch-Korzycka A , Jarmoluk A , et al. Study on alginate–chitosan complex formed with different polymers ratio. Polymers. 2016;8(5):167.
   Web of Science ®Google Scholar
• Li X , Dong W , Nalin AP , et al. The natural product chitosan enhances the anti-tumor activity of natural killer cells by activating dendritic cells. OncoImmunology. 2018;7(6):e1431085.
   PubMed Web of Science ®Google Scholar
• Peh K , Khan T , Ch’ng H. Mechanical, bioadhesive strength and biological evaluations of chitosan films for wound dressing. J Pharm Pharm Sci. 2000;3(3):303–311.
   PubMed Web of Science ®Google Scholar
• Kim S-K. Chitin and chitosan derivatives: advances in drug discovery and developments. Boca Raton (FL): CRC Press; 2013.
   Google Scholar
• Szymańska E , Winnicka K. Stability of chitosan-a challenge for pharmaceutical and biomedical applications. Mar Drugs. 2015;13(4):1819–1846.
   PubMed Web of Science ®Google Scholar
• Costa-Pinto AR , Reis RL , Neves NM. Scaffolds based bone tissue engineering: the role of chitosan. Tissue Eng Part B Rev. 2011;17(5):331–347.
   PubMed Web of Science ®Google Scholar
• Tanigawa T , Tanaka Y , Sashiwa H , et al. Various biological effects of chitin derivative. In: Advances in chitin and chitosan. New York: Elsevier Applied Science; 1992; p. 206–215.
   Google Scholar
• Singla AK , Chawla M. Chitosan: some pharmaceutical and biological aspects-an update. J Pharm Pharmacol. 2001;53(8):1047–1067.
   PubMed Web of Science ®Google Scholar
• Risbud MV , Bhonde RR. Islet immunoisolation: experience with biopolymers. J Biomater Sci Polym Ed. 2001;12(11):1243–1252.
   PubMed Web of Science ®Google Scholar
• Rowe RC , Sheskey P , Quinn M. Handbook of pharmaceutical excipients. 2009. London (UK): Libros Digitales-Pharmaceutical Press.
   Google Scholar
• Pahwa R , Saini N , Kumar V , et al. Chitosan-based gastroretentive floating drug delivery technology: an updated review. Expert Opin Drug Deliv. 2012;9(5):525–539.
   PubMed Web of Science ®Google Scholar
• Luo Y , Wang Q. Recent development of chitosan-based polyelectrolyte complexes with natural polysaccharides for drug delivery. Int J Biol Macromol. 2014;64:353–367.
   PubMed Web of Science ®Google Scholar
• Prajapati VD , Jani GK , Khutliwala TA , et al. Raft forming system-an upcoming approach of gastroretentive drug delivery system. J Control Release. 2013;168(2):151–165.
   PubMed Web of Science ®Google Scholar
• Hampson FC , Farndale A , Strugala V , et al. Alginate rafts and their characterisation. Int J Pharm. 2005;294(1–2):137–147.
   PubMed Web of Science ®Google Scholar
• Qin Y , Jiang J , Zhao L , et al. Chapter 13 - applications of alginate as a functional food ingredient. In: Grumezescu AM , Holban AM , editors. Biopolymers for food design. Cambridge (MA): Academic Press; 2018. p. 409–429.
   Google Scholar
• Hoad CL , Rayment P , Spiller RC , et al. In vivo imaging of intragastric gelation and its effect on satiety in humans. J Nutr. 2004;134(9):2293–2300.
   PubMed Web of Science ®Google Scholar
• Houghton D , Wilcox MD , Chater PI , et al. Biological activity of alginate and its effect on pancreatic lipase inhibition as a potential treatment for obesity. Food Hydrocoll. 2015;49:18–24.
   PubMed Web of Science ®Google Scholar
• Hu X , Tao N , Wang X , et al. Marine-derived bioactive compounds with anti-obesity effect: a review. J Funct Foods. 2016;21:372–387.
   Web of Science ®Google Scholar
• Wilcox MD , Brownlee IA , Richardson JC , et al. The modulation of pancreatic lipase activity by alginates. Food Chem. 2014;146:479–484.
   PubMed Web of Science ®Google Scholar
• Nakazono S , Cho K , Isaka S , et al. Anti-obesity effects of enzymatically-digested alginate oligomer in mice model fed a high-fat-diet. Bioact Carbohydr Dietary Fibre. 2016;7(2):1–8.
   Google Scholar
• Baysal K , Aroguz AZ , Adiguzel Z , et al. Chitosan/alginate crosslinked hydrogels: preparation, characterization and application for cell growth purposes. Int J Biol Macromol. 2013;59:342–348.
   PubMed Web of Science ®Google Scholar
• Yao K , Li J , Yao F , et al. Chitosan-based hydrogels: functions and applications. Boca Raton (FL): CRC Press; 2011.
   Google Scholar
• Hamman JH. Chitosan based polyelectrolyte complexes as potential carrier materials in drug delivery systems. Mar Drugs. 2010;8(4):1305–1322.
   PubMed Web of Science ®Google Scholar
• Jennings JA , Bumgardner JD. Chitosan based biomaterials. Vol. 1. 2017. Available from: http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=1144225.
   Google Scholar
• Hennink WE , van Nostrum CF. Novel crosslinking methods to design hydrogels. Adv Drug Delivery Rev. 2012;64:223–236.
   Web of Science ®Google Scholar
• Coppi G , Iannuccelli V , Leo E , et al. Chitosan-alginate microparticles as a protein carrier. Drug Dev Ind Pharm. 2001;27(5):393–400.
   PubMed Web of Science ®Google Scholar
• Gazori T , Khoshayand MR , Azizi E , et al. Evaluation of Alginate/Chitosan nanoparticles as antisense delivery vector: formulation, optimization and in vitro characterization. Carbohydr Polym. 2009;77(3):599–606.
   Web of Science ®Google Scholar
• Wang L , Khor E , Wee A , et al. Chitosan‐alginate PEC membrane as a wound dressing: Assessment of incisional wound healing. J Biomed Mater Res. 2002;63(5):610–618.
   PubMed Web of Science ®Google Scholar
• Miyazaki S , Nakayama A , Oda M , et al. Chitosan and sodium alginate based bioadhesive tablets for intraoral drug delivery. Biol Pharm Bull. 1994;17(5):745–747.
   PubMed Web of Science ®Google Scholar
• Park D-J , Choi B-H , Zhu S-J , et al. Injectable bone using chitosan-alginate gel/mesenchymal stem cells/BMP-2 composites. J Craniomaxillofac Surg. 2005;33(1):50–54.
   PubMed Web of Science ®Google Scholar
• Lv X , Zhang W , Liu Y , et al. Hygroscopicity modulation of hydrogels based on carboxymethyl chitosan/Alginate polyelectrolyte complexes and its application as pH-sensitive delivery system. Carbohydr Polym. 2018;198:86–93.
   PubMed Web of Science ®Google Scholar
• Henao E , Delgado E , Contreras H , et al. Polyelectrolyte complexation versus ionotropic gelation for chitosan-based hydrogels with carboxymethylcellulose, carboxymethyl starch, and alginic acid. Int J Chem Eng. 2018;2018:1–12.
   Web of Science ®Google Scholar
• El Maghraby GM , Elzayat EM , Alanazi FK. Development of modified in situ gelling oral liquid sustained release formulation of dextromethorphan. Drug Dev Ind Pharm. 2012;38(8):971–978.
   PubMed Web of Science ®Google Scholar
• El Maghraby GM , Elsisi AE , Elmeshad GA. Development of liquid oral sustained release formulations of nateglinide: in vitro and in vivo evaluation. J Drug Delivery Sci Technol. 2015;29:70–77.
   Web of Science ®Google Scholar
• Belhadji L , HadjSadok A , Moulai-Mostefa N. Design and characterization of calcium-free in-situ gel formulation based on sodium alginate and chitosan. Drug Dev Ind Pharm. 2018;44(4):662–669.
   PubMed Web of Science ®Google Scholar
• de Alvarenga ES. Characterization and properties of chitosan. Biotechnol Biopolymers. 2011;91:48–53.
   Google Scholar
• Rinaudc M , Pavlov G , Desbrières J. Solubilization of chitosan in strong acid medium. Int J Polym Anal Charact. 1999;5(3):267–276.
   Web of Science ®Google Scholar
• Knaul JZ , Kasaai MR , Bui VT , et al. Characterization of deacetylated chitosan and chitosan molecular weight review. Can J Chem. 1998;76(11):1699–1706.
   Web of Science ®Google Scholar
• Roux R. Élaboration d’assemblages colloïdaux à partir de nanoparticules de poly (acide lactique) et de chitosane. Université Claude Bernard-Lyon I; 2013.
   Google Scholar
• Tolaimate A , Desbrières J , Rhazi M , et al. On the influence of deacetylation process on the physicochemical characteristics of chitosan from squid chitin. Polymer. 2000;41(7):2463–2469.
   Web of Science ®Google Scholar
• Hajji S , Younes I , Ghorbel-Bellaaj O , et al. Structural differences between chitin and chitosan extracted from three different marine sources. Int J Biol Macromol. 2014;65:298–306.
   PubMed Web of Science ®Google Scholar
• Varum K , Ottoy M , Smidsrod O. Water-solubility of partially N-acetylated chitosans as a function of pH: effect of chemical composition and depolymerisation. Carbohydr Polym. 1994;25:65–70.
   Web of Science ®Google Scholar
• Zhou HY , Chen XG , Kong M , et al. Effect of molecular weight and degree of chitosan deacetylation on the preparation and characteristics of chitosan thermosensitive hydrogel as a delivery system. Carbohydr Polym. 2008;73(2):265–273.
   Web of Science ®Google Scholar
• Honary S , Maleki M , Karami M. The effect of chitosan molecular weight on the properties of alginate/chitosan microparticles containing prednisolone. Trop J Pharm Res. 2009;8(1):53–61.
   Web of Science ®Google Scholar
• Kofuji K , Qian C-J , Nishimura M , et al. Relationship between physicochemical characteristics and functional properties of chitosan. Eur Polym J. 2005;41(11):2784–2791.
   Web of Science ®Google Scholar
• Barnes HA. A handbook of elementary rheology. Aberystwyth: University of Wales, Institute of Non-Newtonian Fluid Mechanics; 2000.
   Google Scholar
• Tsaih ML , Chen RH. Effect of molecular weight and urea on the conformation of chitosan molecules in dilute solutions. Int J Biol Macromol. 1997;20(3):233–240.
   PubMed Web of Science ®Google Scholar
• Kasaai MR , Arul J , Charlet G. Intrinsic viscosity–molecular weight relationship for chitosan. J Polym Sci B Polym Phys. 2000;38(19):2591–2598.
   Web of Science ®Google Scholar
• Kapoor D , Maheshwari R, Verma K et al. Chapter 14 - coating technologies in pharmaceutical product development. In: Tekade RK , editor. Drug delivery systems. Academic Press. 2020. p. 665–719.
   Google Scholar
• Baird JA , Olayo-Valles R , Rinaldi C , et al. Effect of molecular weight, temperature, and additives on the moisture sorption properties of polyethylene glycol. J Pharm Sci. 2010;99(1):154–168.
   PubMed Web of Science ®Google Scholar
• Muti H , Othman S. Effects of binders and moisture content on the disintegration, hardness and friability of paracetamol and orphenadrine citrate tablets. Drug Dev Ind Pharm. 1989;15(12):2017–2035.
   Web of Science ®Google Scholar
• Wikberg M , Alderborn G. Compression characteristics of granulated materials. VII. The effect of intragranular binder distribution on the compactibility of some lactose granulations. Pharm Res. 1993;10(1):88–94.
   PubMed Web of Science ®Google Scholar
• Shah NH , Railkar AS , Phauapradit W , et al. Effect of processing techniques in controlling the release rate and mechanical strength of hydroxypropyl methylcellulose based hydrogel matrices. Eur J Pharm Biopharm. 1996;42(3):183–187.
   Web of Science ®Google Scholar
• European Pharmacopoeia; Council of Europe . Strasbourg: Council of Europe; 2008.
   Google Scholar
• USP, USPC, Inc. The United States Pharmacopeia (USP 24). Rockville (MD), USA. 2000.
   Google Scholar
• Khong TT , Aarstad OA , Skjåk-Braek G , et al. Gelling Concept Combining Chitosan and alginate-proof of principle. Biomacromolecules. 2013;14(8):2765–2771.
   PubMed Web of Science ®Google Scholar
• Pongstabodee S , Monyanon S , Luengnaruemitchai A. Applying a face-centered central composite design to optimize the preferential CO oxidation over a PtAu/CeO2-ZnO catalyst. Int J Hydrogen Energy. 2012;37(6):4749–4761.
   Web of Science ®Google Scholar
• Bodson C. Application de la technologie analytique des procédés dans l’étude de l’homogénéité de mélanges de poudres pour compression directe. 2007.
   Google Scholar
• Lachman L , Lieberman HA , Kanig JL. The theory and practice of industrial pharmacy. Lea & Febiger; 1986.
   Google Scholar
• Popa-Nita S , Alcouffe P , Rochas C , et al. Continuum of structural organization from chitosan solutions to derived physical forms. Biomacromolecules. 2010;11(1):6–12.
   PubMed Web of Science ®Google Scholar
• Sorlier P , Denuzière A , Viton C , et al. Relation between the degree of acetylation and the electrostatic properties of chitin and chitosan. Biomacromolecules. 2001;2(3):765–772.
   PubMed Web of Science ®Google Scholar
• Draget KI , Skjåk-Braek G , Christensen BE , et al. Swelling and partial solubilization of alginic acid gel beads in acidic buffer. Carbohydr Polym. 1996;29(3):209–215.
   Web of Science ®Google Scholar
• Matricardi P , Di Meo C , Coviello T , et al. Interpenetrating Polymer Networks polysaccharide hydrogels for drug delivery and tissue engineering. Adv Drug Deliv Rev. 2013;65(9):1172–1187.
   PubMed Web of Science ®Google Scholar
• Payet L , Ponton A , Agnely F , et al. Caractérisation rhéologique de la gélification d’alginate et chitosane: effet de la température. Rhéologie. 2002;2:46–51.
   Google Scholar
• El-Sakhawy M , Kamel S , Salama A , et al. Preparation and infrared study of cellulose based amphiphilic materials. Cellul Chem Technol. 2018;52:193–200.
   Web of Science ®Google Scholar
• Daemi H , Barikani M. Synthesis and characterization of calcium alginate nanoparticles, sodium homopolymannuronate salt and its calcium nanoparticles. Sci Iranica. 2012;19(6):2023–2028.
   Web of Science ®Google Scholar
• Fernandes Queiroz M , Melo KRT , Sabry DA , et al. Does the use of chitosan contribute to oxalate kidney stone formation? Mar Drugs. 2014;13(1):141–158.
   PubMed Web of Science ®Google Scholar
• Yasmeen S , Kabiraz M , Saha B , et al. Chromium (VI) ions removal from tannery effluent using chitosan-microcrystalline cellulose composite as adsorbent. IRJPAC. 2016;10(4):1–14.
   Google Scholar
• Lawrie G , Keen I , Drew B , et al. Interactions between alginate and chitosan biopolymers characterized using FTIR and XPS. Biomacromolecules. 2007;8(8):2533–2541.
   PubMed Web of Science ®Google Scholar
• Lee S-T , Mi F-L , Shen Y-J , et al. Equilibrium and kinetic studies of copper(II) ion uptake by chitosan-tripolyphosphate chelating resin. Polymer. 2001;42(5):1879–1892.
   Web of Science ®Google Scholar
• Liu Q , Li Q , Xu S , et al. Preparation and properties of 3D printed alginate–chitosan polyion complex hydrogels for tissue engineering. Polymers. 2018;10(6):664.
   PubMed Web of Science ®Google Scholar
• Kirby GH , Harris DJ , Li Q , et al. Poly (acrylic acid)–poly (ethylene oxide) comb polymer effects on BaTiO3 nanoparticle suspension stability. J Am Ceramic Soc. 2004;87(2):181–186.
   Web of Science ®Google Scholar
• Burnett JE , Balkin ER. Stability and viscosity of a flavored omeprazole oral suspension for pediatric use. Am J Health Syst Pharm. 2006;63(22):2240–2247.
   PubMed Web of Science ®Google Scholar
• Lan W , He L , Liu Y. Preparation and properties of sodium carboxymethyl cellulose/sodium alginate/chitosan composite film. Coatings. 2018;8(8):291.
   Web of Science ®Google Scholar
• Wolf BW , Lai C-S , Kipnes MS , et al. Glycemic and insulinemic responses of nondiabetic healthy adult subjects to an experimental acid-induced viscosity complex incorporated into a glucose beverage. Nutrition. 2002;18(7–8):621–626.
   PubMed Web of Science ®Google Scholar