Diacerein solid dispersion loaded tablets for minimization of drug adverse effects: statistical design, formulation, in vitro, and in vivo evaluation

References

• Aggarwal AK, Singh S. 2011. Physicochemical characterization and dissolution study of solid dispersions of diacerein with polyethylene glycol 6000. Drug Dev Ind Pharm. 37(10):1181–1191.
   PubMed Web of Science ®Google Scholar
• Alcaraz MJ, Megías J, García-Arnandis I, Clérigues V, Guillén MI. 2010. New molecular targets for the treatment of osteoarthritis. Biochem Pharmacol. 80(1):13–21.
   PubMed Web of Science ®Google Scholar
• Allam AN, Hamdallah SI, Abdallah OY. 2017. Chitosan-coated diacerein nanosuspensions as a platform for enhancing bioavailability and lowering side effects: preparation, characterization, and ex vivo/in vivo evaluation. Int J Nanomedicine. 12:4733–4745.
   PubMed Web of Science ®Google Scholar
• Allen LV, Jr., Yanchick VA, Maness DD. 1977. Dissolution rates of corticosteroids utilizing sugar glass dispersions. J Pharm Sci. 66(4):494–497.
   PubMed Web of Science ®Google Scholar
• Aziz DE, Abdelbary AA, Elassasy AI. 2018. Fabrication of novel elastosomes for boosting the transdermal delivery of diacerein: statistical optimization, ex-vivo permeation, in-vivo skin deposition and pharmacokinetic assessment compared to oral formulation. Drug Deliv. 25(1):815–826.
   PubMed Web of Science ®Google Scholar
• Bennett RC, Brough C, Miller DA, O’Donnell KP, Keen JM, Hughey JR, Williams RO, McGinity JW. 2015. Preparation of amorphous solid dispersions by rotary evaporation and KinetiSol dispersing: approaches to enhance solubility of a poorly water-soluble gum extract. Drug Dev Ind Pharm. 41(3):382–397.
   PubMed Web of Science ®Google Scholar
• Berenbaum F. 2010. Targeted therapies in osteoarthritis: a systematic review of the trials on www. Best Pract Res Clin Rheumatol. 24(1):107–119.
   PubMed Web of Science ®Google Scholar
• Bhirud YD, Phalak HM. 2016. Advances in solid dispersion technology and its applications in the development of solid dosage forms. J Drug Delivery Ther. 6(6):40–47.
   Google Scholar
• Chen T, Fowler A, Toner M. 2000. Literature review: supplemented phase diagram of the trehalose–water binary mixture. Cryobiology. 40(3):277–282.
   PubMed Web of Science ®Google Scholar
• Chen Y, Zhang G, Neilly J, Marsh K, Mawhinney D, Sanzgiri YD. 2004. Enhancing the bioavailability of ABT-963 using solid dispersion containing Pluronic F-68. Int J Pharm. 286(1–2):69–80.
   PubMed Web of Science ®Google Scholar
• Cid AG, Simonazzi A, Palma SD, Bermúdez JM. 2019. Solid dispersion technology as a strategy to improve the bioavailability of poorly soluble drugs. Ther Deliv. 10(6):363–382.
   PubMed Web of Science ®Google Scholar
• Colombo M, de Lima Melchiades G, Michels LR, Figueiró F, Bassani VL, Teixeira HF, Koester LS. 2019. Solid dispersion of kaempferol: formulation development, characterization, and oral bioavailability assessment. AAPS PharmSciTech. 20(3):106.
   PubMed Web of Science ®Google Scholar
• de Oliveira Eloy J, Saraiva J, de Albuquerque S, Marchetti JM. 2012. Solid dispersion of ursolic acid in Gelucire 50/13: a strategy to enhance drug release and trypanocidal activity. AAPS PharmSciTech. 13(4):1436–1445.
   PubMed Web of Science ®Google Scholar
• Derringer G, Suich R. 1980. Simultaneous optimization of several response variables. J Qual Technol. 12(4):214–219.
   Web of Science ®Google Scholar
• El-Laithy HM, Basalious EB, El-Hoseiny BM, Adel MM. 2015. Novel self-nanoemulsifying self-nanosuspension (SNESNS) for enhancing oral bioavailability of diacerein: simultaneous portal blood absorption and lymphatic delivery. Int J Pharm. 490(1–2):146–154.
   PubMed Web of Science ®Google Scholar
• Elsayed I, Abdelbary AA, Elshafeey AH. 2014. Nanosizing of a poorly soluble drug: technique optimization, factorial analysis, and pharmacokinetic study in healthy human volunteers. Int J Nanomedicine. 9:2943–2953.
   PubMed Web of Science ®Google Scholar
• Eltobshi AA, Mohamed EA, Abdelghani GM, Nouh AT. 2018. Self-nanoemulsifying drug-delivery systems for potentiated anti-inflammatory activity of diacerein. Int J Nanomed. 13:6585–6602.
   PubMed Web of Science ®Google Scholar
• Fraile M, Martín ÿ, Deodato D, Rodriguez-Rojo S, Nogueira ID, Simplício AL, Cocero MJ, Duarte CMM. 2013. Production of new hybrid systems for drug delivery by PGSS (Particles from Gas Saturated Solutions) process. J Supercrit Fluids. 81:226–235.
   Web of Science ®Google Scholar
• Garthe OM, Kothawade PS, Mahajan VR. 2013. Solubility enhancement of diacerein by solid dispersion technique. Int J Pharma Res Allied Sci. 2(2):47–55.
   Google Scholar
• Ghanem A, Meshali M, Ibraheem Y. 1980. Dissolution rates of sulfamethoxazole utilizing sugar glass dispersions. J Pharm Pharmacol. 32(10):675–677.
   PubMed Web of Science ®Google Scholar
• Hasan A, Abd El Hakim R, Mahmoud Abd E, Shereen S. 2020. Design and characterization of intra-oral fast dissolving tablets containing diacerein-solid dispersion. J Appl Pharma Sci. 10(06):44.
   Google Scholar
• Jain A, Mishra SK, Vuddanda PR, Singh SK, Singh R, Singh S. 2014. Targeting of diacerein loaded lipid nanoparticles to intra-articular cartilage using chondroitin sulfate as homing carrier for treatment of osteoarthritis in rats. Nanomed Nanotechnol Biol Med. 10(5):e1031–e1040.
   PubMed Web of Science ®Google Scholar
• Jain A, Singh R, Singh S, Singh S. 2015. Diacerein protects against iodoacetate-induced osteoarthritis in the femorotibial joints of rats. J Biomed Res. 29(5):405–413.
   PubMed Web of Science ®Google Scholar
• Jain A, Singh SK, Singh Y, Singh S. 2013. Development of lipid nanoparticles of diacerein, an antiosteoarthritic drug for enhancement in bioavailability and reduction in its side effects. J Biomed Nanotechnol. 9(5):891–900.
   PubMed Web of Science ®Google Scholar
• Khan KA. 1975. The concept of dissolution efficiency. J Pharm Pharmacol. 27(1):48–49.
   PubMed Web of Science ®Google Scholar
• Khan MI, Madni A, Peltonen L. 2016. Development and in-vitro characterization of sorbitan monolaurate and poloxamer 184 based niosomes for oral delivery of diacerein. Eur J Pharm Sci. 95:88–95.
   PubMed Web of Science ®Google Scholar
• Kolašinac N, Kachrimanis K, Homšek I, Grujić B, Ðurić Z, Ibrić S. 2012. Solubility enhancement of desloratadine by solid dispersion in poloxamers. Int J Pharm. 436(1–2):161–170.
   PubMed Web of Science ®Google Scholar
• Lana JFdSD, Rodrigues BL 2019. Osteoarthritis as a chronic inflammatory disease: a review of the inflammatory markers. London (UK): IntechOpen.
   Google Scholar
• Li J, Li Y, Lee T, Huang Q. 2013. Structure and physical properties of zein/Pluronic F127 composite films. J Agric Food Chem. 61(6):1309–1318.
   PubMed Web of Science ®Google Scholar
• Lindner WD, Lippold BC. 1995. Drug release from hydrocolloid embeddings with high or low susceptibility to hydrodynamic stress. Pharm Res. 12(11):1781–1785.
   PubMed Web of Science ®Google Scholar
• Mohamed MI, Al-Mahallawi AM, Awadalla SM. 2020. Development and optimization of osmotically controlled drug delivery system for poorly aqueous soluble diacerein to improve its bioavailability. Drug Dev Ind Pharm. 46(5):814–825.
   PubMed Web of Science ®Google Scholar
• Mohamed MS, Abdelhafez WA, Zayed G, Samy AM. 2019. In vitro and in vivo characterization of fast dissolving tablets containing gliquidone–Pluronic solid dispersion. Drug Dev Ind Pharm. 45(12):1973–1981.
   PubMed Web of Science ®Google Scholar
• Mohammed KAB, Ibrahim HK, Ghorab MM. 2016. Effervescent tablet formulation for enhanced patient compliance and the therapeutic effect of risperidone. Drug Deliv. 23(1):297–306.
   PubMed Web of Science ®Google Scholar
• Nagasamy VD, Arun R, Saraswathi S, Priya MP, Khan NI, Kathirulla N, Sruthi S. 2017. Dissolution enhancement of diacerein using water soluble carrier by solid dispersion technology. J Drug Delivery Ther. 7(5):33–41.
   Google Scholar
• Naima Z, Siro T, Juan-Manuel G, Chantal C, René C, Jerome D. 2001. Interactions between carbamazepine and polyethylene glycol (PEG) 6000: characterisations of the physical, solid dispersed and eutectic mixtures. Eur J Pharm Sci. 12(4):395–404.
   PubMed Web of Science ®Google Scholar
• Naseef MA, Ibrahim HK, Nour SAE. 2018. Solid form of lipid-based self-nanoemulsifying drug delivery systems for minimization of diacerein adverse effects: development and bioequivalence evaluation in albino rabbits. AAPS PharmSciTech. 19(7):3097–3109.
   PubMed Web of Science ®Google Scholar
• Ngo AN, Thomas D, Murowchick J, Ayon NJ, Jaiswal A, Youan BC. 2018. Engineering fast dissolving sodium acetate mediated crystalline solid dispersion of docetaxel. Int J Pharm. 545(1–2):329–341.
   PubMed Web of Science ®Google Scholar
• Panda T, Das D, Panigrahi L. 2016. Formulation development of solid dispersions of bosentan using Gelucire 50/13 and poloxamer 188. J Appl Pharm Sci. 6:27.
   Google Scholar
• Parekh KK, Paun JS, Soniwala MM. 2017. Formulation and evaluation of nanosuspension to improve solubility and dissolution of diacerein. Int J Pharm Sci Res. 8(4):1643.
   Web of Science ®Google Scholar
• Passerini N, Perissutti B, Moneghini M, Voinovich D, Albertini B, Cavallari C, Rodriguez L. 2002. Characterization of carbamazepine–Gelucire 50/13 microparticles prepared by a spray‐congealing process using ultrasounds. J Pharm Sci. 91(3):699–707.
   PubMed Web of Science ®Google Scholar
• Patil SB, Shete DK, Narade SB, Surve SS, Khan ZK, Bhise SB, Pore YV. 2010. Improvement in the dissolution profile of diacerein using a surfactant-based solid dispersion technique. Drug Discov Ther. 4(6):435–441.
   PubMedGoogle Scholar
• Patterson JE, James MB, Forster AH, Lancaster RW, Butler JM, Rades T. 2007. Preparation of glass solutions of three poorly water soluble drugs by spray drying, melt extrusion and ball milling. Int J Pharm. 336(1):22–34.
   PubMed Web of Science ®Google Scholar
• Potluri RHK, Bandari S, Jukanti R, Veerareddy PR. 2011. Solubility enhancement and physicochemical characterization of carvedilol solid dispersion with Gelucire 50/13. Arch Pharm Res. 34(1):51–57.
   PubMed Web of Science ®Google Scholar
• Radwan SAA, El-Maadawy WH, ElMeshad AN, Shoukri RA, Yousry C. 2020. Impact of reverse micelle loaded lipid nanocapsules on the delivery of gallic acid into activated hepatic stellate cells: a promising therapeutic approach for hepatic fibrosis. Pharm Res. 37(9):1–17.
   Web of Science ®Google Scholar
• Radwan SAA, El-Maadawy WH, Yousry C, ElMeshad AN, Shoukri RA. 2020. Zein/phospholipid composite nanoparticles for successful delivery of gallic acid into aHSCs: influence of size, surface charge, and vitamin A coupling. Int J Nanomedicine. 15:7995–8018.
   PubMed Web of Science ®Google Scholar
• Rockville MD, editor. 2012. United States Pharmacopeia and National Formulary (USP 35-NF 30). Rockville (MD): USP-NF. p. 5160–5174.
   Google Scholar
• Saleh A, McGarry K, Chaw CS, Elkordy AA. 2018. Feasibility of using gluconolactone, trehalose and hydroxy-propyl gamma cyclodextrin to enhance bendroflumethiazide dissolution using lyophilisation and physical mixing techniques. Pharmaceutics. 10(1):22.
   Web of Science ®Google Scholar
• Sankari T, Al-Hariri S. 2018. Preparation and characterization of cefuroxime axetil solid dispersions using poloxamer 188. Braz J Pharm Sci. 54(4):e17644.
   Web of Science ®Google Scholar
• Sekiguchi K, Obi N. 1961. Studies on absorption of eutectic mixture. I. A comparison of the behavior of eutectic mixture of sulfathiazole and that of ordinary sulfathiazole in man. Chem Pharm Bull. 9(11):866–872.
   Web of Science ®Google Scholar
• Sostres C, Gargallo CJ, Arroyo MT, Lanas A. 2010. Adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs, aspirin and coxibs) on upper gastrointestinal tract. Best Pract Res Clin Gastroenterol. 24(2):121–132.
   PubMed Web of Science ®Google Scholar
• Surampalli G, Nanjwade BK, Patil PA, Chilla R. 2016. Novel tablet formulation of amorphous candesartan cilexetil solid dispersions involving P-gp inhibition for optimal drug delivery: in vitro and in vivo evaluation. Drug Deliv. 23(7):2124–2138.
   PubMed Web of Science ®Google Scholar
• Suzuki H, Yakushiji K, Matsunaga S, Yamauchi Y, Seto Y, Sato H, Onoue S. 2018. Amorphous solid dispersion of meloxicam enhanced oral absorption in rats with impaired gastric motility. J Pharm Sci. 107(1):446–452.
   PubMed Web of Science ®Google Scholar
• Tran P, Pyo Y, Kim D, Lee S, Kim J, Park J. 2019. Overview of the manufacturing methods of solid dispersion technology for improving the solubility of poorly water-soluble drugs and application to anticancer drugs. Pharmaceutics. 11(3):132.
   PubMed Web of Science ®Google Scholar
• Verhoeven N, Neoh TL, Furuta T, Yamamoto C, Ohashi T, Yoshii H. 2012. Characteristics of dehydration kinetics of dihydrate trehalose to its anhydrous form in ethanol by DSC. Food Chem. 132(4):1638–1643.
   Web of Science ®Google Scholar
• Vippagunta SR, Maul KA, Tallavajhala S, Grant DJ. 2002. Solid-state characterization of nifedipine solid dispersions. Int J Pharm. 236(1–2):111–123.
   PubMed Web of Science ®Google Scholar
• Volpato NM, Silva RL, Brito APP, Gonçalves JCS, Vaisman M, Noël F. 2004. Multiple level C in vitro/in vivo correlation of dissolution profiles of two l-thyroxine tablets with pharmacokinetics data obtained from patients treated for hypothyroidism. Eur J Pharm Sci. 21(5):655–660.
   PubMed Web of Science ®Google Scholar
• Vos T, Abajobir AA, Abate KH, Abbafati C, Abbas KM, Abd-Allah F, Abdulkader RS, Abdulle AM, Abebo TA, Abera SF, et al. 2017. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet. 390(10100):1211–1259.
   PubMed Web of Science ®Google Scholar
• Xi Z, Sharma N, Paprikar A, Lin S. 2019. Development and evaluation of dipyridamole sustained release tablets containing micro-environmental pH modifiers. J Drug Delivery Sci Technol. 54:101231.
   Web of Science ®Google Scholar
• Xu L, Faruqu FN, Liam-Or R, Abu Abed O, Li D, Venner K, Errington RJ, Summers H, Wang JT, Al-Jamal KT. 2020. Design of experiment (DoE)-driven in vitro and in vivo uptake studies of exosomes for pancreatic cancer delivery enabled by copper-free click chemistry-based labelling. J Extracell Vesicles. 9(1):1779458.
   PubMed Web of Science ®Google Scholar
• Zaki RM, Ali AA, El Menshawi SF, Bary AA. 2013. Effect of binary and ternary solid dispersions prepared by fusion method on the dissolution of poorly water soluble diacerein. Int J Drug Deliv. 5(1):99.
   Google Scholar