title: A novel dissolution media for testing drug release from a nanostructured polysaccharide-based colon specific drug delivery system: an approach to alternative colon media.
abstract: The aim of this study was to develop a novel microbially triggered and animal-sparing dissolution method for testing of nanorough polysaccharide-based micron granules for colonic drug delivery. In this method, probiotic cultures of bacteria present in the colonic region were prepared and added to the dissolution media and compared with the performance of conventional dissolution methodologies (such as media with rat cecal and human fecal media). In this study, the predominant species (such as Bacteroides, Bifidobacterium, Lactobacillus species, Eubacterium and Streptococcus) were cultured in 12% w/v skimmed milk powder and 5% w/v grade "A" honey. Approximately 10(10)-10(11) colony forming units m/L of probiotic culture was added to the dissolution media to test the drug release of polysaccharide-based formulations. A USP dissolution apparatus I/II using a gradient pH dissolution method was used to evaluate drug release from formulations meant for colonic drug delivery. Drug release of guar gum/Eudragit FS30D coated 5-fluorouracil granules was assessed under gastric and small intestine conditions within a simulated colonic environment involving fermentation testing with the probiotic culture. The results with the probiotic system were comparable to those obtained from the rat cecal and human fecal-based fermentation model, thereby suggesting that a probiotic dissolution method can be successfully applied for drug release testing of any polysaccharide-based oral formulation meant for colonic delivery. As such, this study significantly adds to the nanostructured biomaterials' community by elucidating an easier assay for colonic drug delivery.
authors.affiliation: School of Pharmaceutical Sciences, Lovely Professional University, Punjab, India; Technologies for the Advancement of Science, Institute for Stem Cell Biology and Regenerative Medicine, Bangalore, Karnataka, India.
authors.forename: Niranjan G
authors.initials: NG
authors.lastname: Kotla
authors.affiliation: School of Pharmaceutical Sciences, Lovely Professional University, Punjab, India; Department of Pharmaceutical Sciences, Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India.
authors.forename: Sima
authors.initials: S
authors.lastname: Singh
authors.affiliation: Department of Pharmaceutics, Vishwabharathi College of Pharmaceutical Sciences, Guntur, Andhra Pradesh, India.
authors.forename: Balaji
authors.initials: B
authors.lastname: Maddiboyina
authors.affiliation: Technologies for the Advancement of Science, Institute for Stem Cell Biology and Regenerative Medicine, Bangalore, Karnataka, India.
authors.forename: Omprakash
authors.initials: O
authors.lastname: Sunnapu
authors.affiliation: Department of Chemical Engineering, Northeastern University, Boston, MA, USA; Center of Excellence for Advanced Materials Research, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Webster
mesh_terms: D000818:Animals; D003106:Colon / Q000187:drug effects*; D003470:Culture Media / Q000737:chemistry; D004337:Drug Carriers / Q000008:administration & dosage / Q000737:chemistry / Q000493:pharmacokinetics*; D016503:Drug Delivery Systems / Q000379:methods*; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D065546:Drug Liberation; D005243:Feces / Q000382:microbiology; D005472:Fluorouracil / Q000008:administration & dosage; D005685:Galactans / Q000737:chemistry; D006801:Humans; D008351:Mannans / Q000737:chemistry; D049329:Nanostructures / Q000737:chemistry*; D053149:Plant Gums / Q000737:chemistry; D011109:Polymethacrylic Acids; D011134:Polysaccharides / Q000737:chemistry; D019936:Probiotics; D051381:Rats; D012995:Solubility
chemical_list: D003470:Culture Media; D004337:Drug Carriers; D005685:Galactans; D008351:Mannans; D053149:Plant Gums; D011109:Polymethacrylic Acids; D011134:Polysaccharides; C038300:methylmethacrylate-methacrylic acid copolymer; C007894:guar gum; D005472:Fluorouracil
keywords: colon specific drug delivery; dissolution methodologies; microbially triggered drug delivery; probiotic media; simulated colonic media