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Alex Yu, Jason R Baker, Ann F Fioritto, Ying Wang, Ruijuan Luo, Siwei Li, Bo Wen, Michael Bly, Yasuhiro Tsume, Mark J Koenigsknecht, Xinyuan Zhang, Robert Lionberger, Gordon L Amidon, William L Hasler, Duxin Sun
As an orally administered, locally acting gastrointestinal drug, mesalamine products are designed to achieve high local drug concentration in the gastrointestinal (GI) tract for the treatment of ulcerative colitis. The aim of this study was to directly measure and compare drug dissolution of three mesalamine formulations in human GI tract and to correlate their GI concentration with drug concentration in plasma. Healthy human subjects were orally administered Pentasa, Apriso, or Lialda. GI fluids were aspirated from stomach, duodenum, proximal jejunum, mid jejunum, and distal jejunum regions...
February 6, 2017: Molecular Pharmaceutics
Alvaro Goyanes, Grace B Hatton, Hamid A Merchant, Abdul W Basit
The aminosalicylate mesalazine (mesalamine) forms the mainstay of treatment in ulcerative colitis (UC), a disease for which many commercial modified-release products have been developed with the aim of providing targeted gastrointestinal release. The release profiles of five of these commercial formulations were evaluated in bicarbonate buffer using a novel dissolution model that mimics the dynamic conditions of the gastrointestinal tract. Monolithic and multi-particulate mesalazine formulations with pH-dependent and/or independent release mechanisms were evaluated (Asacol(®) 800, Octasa(®), Mezavant(®) XL, Salofalk(®), Pentasa(®)), and each of the products displayed a distinctive dissolution profile...
April 30, 2015: International Journal of Pharmaceutics
Irina Kadiyala, Dylan Jacobs
This patent review focuses exclusively on the oral delivery of mesalamine (5-ASA) and excludes oral mesalamine pro-drug and rectal delivery formulations. The formulation strategies of marketed formulations (Apriso(®), Asacol(®), Lialda(®) and Pentasa(®)) and non-marketed formulations are reviewed and explained by decoding formulation specifics that enable the site specific delivery for the treatment of inflammatory bowel disease.
April 2014: Recent Patents on Drug Delivery & Formulation
Sara N Horst, Sunanda Kane
INTRODUCTION: Ulcerative colitis (UC) is an inflammatory disease of the colon characterized by periods of active disease and remission. The pathogenesis of this disease is likely a complex interaction of genetic predisposition, environmental factors, and immune system dysregulation, and is not completely understood. A Multi-MatriX (MMX®) system formulation of mesalamine, MMX mesalamine (SPD476; Lialda®; Mesavancol®; Mezavant®), allows for high-dose, once-daily dosing for patients with mild-to-moderate UC...
October 2012: Expert Opinion on Pharmacotherapy
Kavinderjit Nanda, Alan C Moss
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon that typically manifests as diarrhea, abdominal pain, and bloody stool. Complications, such as colorectal cancer and extraintestinal manifestations, may also develop. The goals of management are to induce and maintain clinical remission and to screen for complications of this disease. Mesalamine is a 5-aminosalicylic acid compound that is the first-line therapy to induce and maintain clinical remission in patients with mild-to-moderate UC...
2012: Clinical Pharmacology: Advances and Applications
Derrick J Stobaugh, Parakkal Deepak, Matthew Thorpe, Bruce Hannon, Eli D Ehrenpreis
BACKGROUND: 5-Aminosalicylate (5-ASA) formulations are approved for the treatment of ulcerative colitis (UC). Determination of the colonic pharmacokinetics of 5-ASA is challenging. A dynamic model of 5-ASA colonic amounts after oral delayed-release 5-ASA (Asacol), oral extended delayed-release 5-ASA (Lialda), 5-ASA enema (Rowasa), foam and suppositories (Canasa) was developed to determine the colonic kinetics of these agents. METHODS: We created a model with Stella software...
February 2013: Inflammatory Bowel Diseases
Geert D'Haens, William J Sandborn, Karen Barrett, Ian Hodgson, Paul Streck
OBJECTIVES: Treatment with mesalamine to maintain endoscopic remission (mucosal healing) of ulcerative colitis (UC) has been shown to reduce the risk of relapse and is the recommended first-line maintenance therapy. To improve treatment adherence, a mesalamine formulation that can be administered once-daily, MMX(®) mesalamine (Lialda; Shire Pharmaceuticals LLC, Wayne, PA), was developed. This study was conducted to determine the efficacy and safety of once-daily MMX mesalamine compared with twice-daily delayed-release mesalamine (Asacol; Warner Chilcott, Dublin, Ireland) for maintaining endoscopic remission in patients with UC...
July 2012: American Journal of Gastroenterology
Sunanda V Kane, Michael Sumner, Dory Solomon, Matthew Jenkins
BACKGROUND: Patients receiving 5-aminosalicylic acid (5-ASA) require long-term therapy to achieve good outcomes. Persistency (duration of time from initiation to discontinuation of therapy) is therefore an important consideration. AIM: To evaluate persistency in patients receiving various oral 5-ASA formulations. METHODS: This retrospective, 12-month, cohort study examined new-starter patients (any age and diagnosis) from a large United States pharmacy database who filled a prescription for oral 5-ASA [Lialda(®), Asacol(®), Pentasa(®) 250 or 500 mg, balsalazide (generic and Colazal(®)), and olsalazine (Dipentum(®))] between March and September 2007...
December 2011: Digestive Diseases and Sciences
Lily P H Yang, Paul L McCormack
The Multi MatriX system (MMX®) formulation of mesalazine (Lialda®; Mesavancol®; Mezavant®) [henceforth referred to as MMX mesalazine] is an oral, high-dose, once-daily, gastro-resistant, prolonged-release formulation indicated for use in patients with mild to moderate ulcerative colitis. Mesalazine has numerous anti-inflammatory effects on the mucosa of the colon, parts of which are frequently inflamed in ulcerative colitis. MMX mesalazine is believed to act topically. Therapy with MMX mesalazine 2.4 or 4...
January 22, 2011: Drugs
Hala M Fadda, Hamid A Merchant, Basel T Arafat, Abdul W Basit
Bicarbonate media are reflective of the ionic composition and buffer capacity of small intestinal luminal fluids. Here we investigate methods to stabilise bicarbonate buffers which can be readily applied to USP-II dissolution apparatus. The in vitro drug release behaviour of three enteric coated mesalazine (mesalamine) products is investigated. Asacol 400 mg and Asacol 800 mg (Asacol HD) and the new generation, high dose (1200 mg) delayed and sustained release formulation, Mezavant (Lialda), are compared in pH 7...
December 1, 2009: International Journal of Pharmaceutics
(no author information available yet)
Apriso (Salix) is a new formulation of mesalamine (5-aminosalicylic acid; 5-ASA) approved by the FDA for maintenance of remission in mild to moderate ulcerative colitis (UC). Mesalamine is a locally acting antiinflammatory agent that is widely used both to maintain and induce remission in inflammatory bowel disease. Various mesalamine formulations have been developed to target drug delivery to areas of the small intestine and colon. Most of these agents require frequent dosing and have a high pill burden. The newest products--Lialda, introduced in 2007, and now Apriso--can be dosed once daily...
May 18, 2009: Medical Letter on Drugs and Therapeutics
Mary Y Hu, Mark A Peppercorn
BACKGROUND: 5-Aminosalicylate (5-ASA) agents are the first-line therapy for ulcerative colitis (UC). A high-dose, once-daily formulation of 5-ASA known as MMX mesalamine has recently been approved for the treatment of UC. OBJECTIVE: To summarize current data on MMX mesalamine and to discuss its impact on management of UC. METHODS: A systematic review of published literature was performed on PubMed using the search terms 'MMX mesalamine' and 'Lialda'...
April 2008: Expert Opinion on Pharmacotherapy
Pramodini B Kale-Pradhan, Rohan S Pradhan, Sheila M Wilhelm
OBJECTIVE: To evaluate the role of Multi-Matrix System (MMX) mesalamine in the treatment of ulcerative colitis (UC). DATA SOURCES: Literature was obtained through searches of MEDLINE (1966-October 2007) and a bibliographic review of published articles. Key terms used in the searches included ulcerative colitis, mesalamine, MMX, SPD476, and Lialda. STUDY SELECTION AND DATA EXTRACTION: All English-language articles that were identified through the search were evaluated...
February 2008: Annals of Pharmacotherapy
W J Sandborn, M A Kamm, G R Lichtenstein, A Lyne, T Butler, R E Joseph
MMX mesalazine [LIALDA (US), MEZAVANT XL (UK and Ireland) MEZAVANT (elsewhere)] utilizes MMX Multi Matrix System (MMX) technology which delivers mesalazine throughout the colon. Two phase III studies have already evaluated MMX mesalazine in patients with active, mild-to-moderate ulcerative colitis. Aim To provide more precise estimates of the efficacy of MMX mesalazine over placebo by combining the patient populations from the two phase III studies. Methods Combined data from two 8-week, double-blind, placebo-controlled trials were analyzed...
July 15, 2007: Alimentary Pharmacology & Therapeutics
(no author information available yet)
No abstract text is available yet for this article.
March 26, 2007: Medical Letter on Drugs and Therapeutics
Michael A Kamm, William J Sandborn, Miguel Gassull, Stefan Schreiber, Lechoslaw Jackowski, Todd Butler, Andrew Lyne, David Stephenson, Mary Palmen, Raymond E Joseph
BACKGROUND & AIMS: SPD476 (LIALDA in the US; MEZAVANT in the EU; otherwise known as MMX mesalamine; Shire Pharmaceuticals Inc., Wayne, PA, under license from Giuliani SpA, Milan, Italy) is a novel, once-daily, high-strength (1.2 g/tablet) formulation of mesalamine, utilizing MMX Multi Matrix System (MMX) technology designed to deliver the active drug throughout the colon. We performed a double-blind, multicenter study, comparing MMX mesalamine vs placebo for the treatment of active ulcerative colitis...
January 2007: Gastroenterology
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