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Combination Products (combination + products)
Selected AbstractsYour Drug, My Drug, or Our Drugs: How Aggressive Should We Be With Antihypertensive Therapy?JOURNAL OF CLINICAL HYPERTENSION, Issue 2005Joseph L. Izzo Jr. MD In the prevention of hypertensive complications, especially stroke and kidney disease, "lower is better" because for each decrease of 20 mm Hg systolic or 10 mm Hg diastolic pressure in the population, cardiovascular risk is halved. Ideally, the goal for each patient should be to reach the lowest blood pressure that is well tolerated, a value that may be well below the arbitrary threshold value of 140/90 mm Hg. For the majority of "uncomplicated hypertensives," the question of single-drug therapy is essentially moot, because more than one agent is almost always required to optimally control blood pressure. In individuals who already have heart or kidney disease, there are compelling indications for the use of drugs that block the renin-angiotensin system, but the large outcome studies that spawned these recommendations are themselves combination trials. Thus, in virtually all patients, more than one drug is indicated. The best combinations take advantage of long durations of action and complementary mechanisms of action of the component and are not only able to effectively lower blood pressure, but also to favorably affect the natural history of hypertensive complications. Regimens,including fixed-dose combination products,that combine a thiazide diuretic or calcium antagonist with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker are most efficient. In summary, why would an astute clinician (or informed patient) be satisfied with the relatively limited effects of any single class of antihypertensive agents when better overall protection is possible? [source] Asthma medication , persistence with adrenergics, steroids and combination products over a 5-year periodJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 5 2009D. Haupt RPh Summary Background:, Many patients with asthma underuse steroids for inhalation. This has been identified as a main cause of therapy failure and of excess health care utilization. Objective:, To elucidate the medication persistence of patients using asthma drugs, how patients combine the drugs over time and whether medication persistence was influenced by patients switching to combination products. Methods:, Individual patients' drug acquisition data were obtained from a pharmacy record database for the period 2000,2004. A patient was considered to have satisfactory medication possession ratio (MPR) if the medication supplies covered ,80% of the prescribed treatment. Drug use profiles were constructed as graphs for each patient, showing the date of each refill and the time period covered by the dispensed drugs. From the graphs the combination of drugs, the continuity of the therapy over time and the MPR for each patient could be determined. Results:, Of 1812 patients with asthma drugs in the database, 815 fulfilled the inclusion criteria. The percentage of patients with satisfactory MPR was low (11,27%), but significantly higher among patients using combination products than among those using steroids. For patients who switched from adrenergics plus steroids in two inhalers to combination products in one inhaler, the number of patients with satisfactory MPR was significantly increased. Conclusion:, Satisfactory MPR was low for all types of asthma drugs. More patients had satisfactory MPR with combination products in one inhaler than with adrenergics and steroids in two separate inhalers. Asthma drug-delivery is important and combination products of the two ingredients could therefore improve asthma therapy. [source] Lipid formulation strategies for enhancing intestinal transport and absorption of P-glycoprotein (P-gp) substrate drugs: In vitro/In vivo case studiesJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 2 2007Panayiotis P. Constantinides Abstract The intestinal efflux pump, P-glycoprotein (P-gp), located in the apical membranes of intestinal absorptive cells, can reduce the bioavailability of a wide range of drugs which are substrates for this membrane transporter. In addition to anticancer and anti-HIV drugs, NCEs for other disease indications are P-gp substrates and there is considerable interest in inhibiting P-gp and thus increasing the bioavailability of these molecules. In this review article, an overview of P-gp and its role in drug transport and absorption will be presented first and then formulation strategies to effectively inhibit P-gp will be discussed and compared. These strategies independently and in combination, are: (a) coadministration of another P-gp substrate/specific inhibitor, and (b) incorporation of a nonspecific lipid and/or polymer excipient in the formulation. The first approach, although very effective in inhibiting P-gp, utilizes a second active compound in the formulation and thus imposes regulatory constraints and long development timelines on such combination products. Excipient inhibitors appear to have minimal nonspecific pharmacological activity and thus potential side effects of specific active compound inhibitors can be avoided. Case studies will be presented where specific active compounds, surfactants, polymers, and formulations incorporating these molecules are shown to significantly improve the intestinal absorption of poorly soluble and absorbed drugs as a result of P-gp inhibition and enhanced drug transport in vitro. ©2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 96:235,248, 2007 [source] The diagnosis and management of haemorrhoidal disease from a global perspectiveALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2010L. ABRAMOWITZ Summary Background, A treatment approach for patients with haemorrhoidal disease and other anal disease, which includes the use of topical corticosteroids and other topical combination products, is widely accepted, but little has been published to compare such treatments. This publication is a valuable collection of reading material for gastroenterologists, proctologists, general practitioners, dermatologists and other clinicians who are responsible for diagnosing and managing patients with haemorrhoidal disease. Aims, To review and collect existing treatment approaches for haemorrhoidal disease, by reviewing global experience from clinicians that will contribute towards improving best practice in the management of patients. Methods, The articles include overviews of haemorrhoidal disease, differential diagnosis, topical treatment and surgical practices and patient outcomes. Case studies further reinforce treatments from individual specialists. Results, The articles between them address the classification of haemorrhoids, dermatological differential diagnoses of anal and perianal disease, and the therapeutic management of different haemorrhoidal diseases including invasive surgical and non-invasive topical combination treatments. The case studies indicate the positive impact of appropriate treatment in everyday clinical practice. Conclusion, This publication will reinforce best practice in the causative and symptomatic treatment of haemorrhoidal disease. Aliment Pharmacol Ther,31 (Suppl. 1), 1,58 [source] GLPs and medical devicesQUALITY ASSURANCE JOURNAL, Issue 2 2002Linda Palagi Lynn Abstract Applying Good Laboratory Practice (GLP) regulations to studies of medical devices and combination products (drug/device products) presents some unique challenges. The complexity of medical devices , which may be internal, external, or composed of many intricate parts including software, hardware, or drugs to perform their intended task , requires interpretation of the regulations. Further, the dynamics of the conduct of non-clinical laboratory studies for medical devices can be quite complex often involving a team of scientists, engineers, computer specialists, technicians, veterinarians, physicians, pathologists and equipment from both the test facility and sponsor. This article highlights areas of the GLP regulations and provides information and suggestions for GLP compliance for medical device studies. Copyright © 2002 John Wiley & Sons, Ltd. [source] | ||||||||||