Drugs online research references
Drug Dev Ind Pharm. 1998 Jun;24(6):493-500.
Effect of glycine/citric acid on the dissolution stability of hard gelatin capsules.
Adesunloye TA, Stach PE.
Geneva Pharmaceuticals, Broomfield, Colorado 80038-0446, USA.
Gelatin capsule crosslinking is a well-known phenomenon that results in reduced dissolution of capsule products with the passage of time and/or under accelerated stability conditions. These studies describe one means of preventing capsule crosslinking by incorporating glycine and citric acid into a triamterene/hydrochlorothiazide 37.5/25 mg capsule formulation (triam/HCTZ). Triam/HCTZ without glycine and citric acid showed extensive capsule crosslinking and then failed the USP dissolution specification after a 4-week accelerated (40 degrees C/85% relative humidity [RH]) stability study. Triam/HCTZ containing glycine alone showed some improvement in the dissolution stability but did not prevent gelatin crosslinking. This formulation also failed dissolution specifications after a 4-week accelerated stability study. The same results were obtained when only citric acid was incorporated into the triam/HCTZ. However when glycine and citric acid were incorporated together into the triam/HCTZ, crosslinking was completely prevented. Dissolution profiles remained the same throughout 12-week accelerated stability studies, with little or no drop in the dissolution values throughout the test period. The above results were confirmed with follow-up studies using gemfibrozil and piroxicam as model drugs. Disintegration times for gemfibrozil and piroxicam capsule formulations without glycine and citric acid increased dramatically with observed pellicle formation, but there was little or no change in the disintegration time of the model drugs formulated with glycine and citric acid. The results of these studies demonstrated that when glycine and citric acid are present in some gelatin capsule formulations, pellicle formation or crosslinking of the capsule gelatin is prevented.
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9876614&dopt=Abstract
J Lab Clin Med. 1990 May;115(5):603-9.
Safety and efficacy of combined gemfibrozil-lovastatin therapy for primary dyslipoproteinemias.
Glueck CJ, Speirs J, Tracy T.
Cholesterol Center, Jewish Hospital, Cincinnati, OH 45229.
In 25 patients with primary dyslipoproteinemias and severe premature atherosclerosis, during an average combined Lopid-Mevacor treatment span of 12.5 months per patient, our specific aim was to assess safety and efficacy of open-label therapy with diet, gemfibrozil (Lopid), and lovastatin (Mevacor). Because targeted lipid values were not reached on diet alone (low-density lipoprotein cholesterol [LDLC] less than 120 mg/dl, high-density lipoprotein cholesterol [HDLC] greater than 35 mg/dl or total cholesterol [TC]/HDLC less than 4.5), the patients received Lopid, 1.2 gm/day as their initial lipid-lowering drug. Because targeted lipid levels were not reached with Lopid treatment alone after 3 or more months, Mevacor was added, with 17 subjects receiving 20 mg/day, five receiving 40 mg, two receiving 60 mg, and one receiving 80 mg. Outpatient visits were repeated during combined therapy every 6 to 8 weeks, with an average of 6.4 visits per subject, 162 measurements of fasting lipids and liver function tests, and 127 measurements of creatine phosphokinase (CPK). By selection, all patients had normal liver function (gamma-glutamyltransferase, serum glutamic-oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT) levels) and normal CPK levels at baseline. No gamma-glutamyltransferase levels were high during combined therapy. Of the 162 liver function test measurements, five (3.1%) SGOT levels and three (1.9%) SGPT levels were high. Of 127 CPK measurements, three (2.4%) were high; one subject had a high CPK measurement, and one subject had two high measurements for CPK. No symptomatic myositis or myalgias developed in the subjects; none had palpable skeletal muscle tenderness.(ABSTRACT TRUNCATED AT 250 WORDS)
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=2341762&dopt=Abstract
rti.org
Gemfibrozil, a human pharmaceutical agent, causes hepatomegaly and hepatic peroxisome proliferation in rats, which have been associated with hepatocarcinogenesis. Hamsters are less susceptible than rats to peroxisome proliferation, and no hepatotoxicity has been reported in humans using gemfibrozil. The relationship between hepatic peroxisome proliferation in rodents and human cancer risk is unclear. We investigated the metabolism and excretion of [14C]gemfibrozil in male and female Sprague-Dawley rats and Syrian golden hamsters to better understand species differences in gemfibrozil-induced toxicity. Bile-duct cannulated rats and hamsters excreted 99% and 7 to 20% of a single i.v. gemfibrozil dose in bile, respectively. Cumulative urinary and fecal excretion of gemfibrozil-derived radioactivity after a single oral dose (30 or 2000 mg/kg) were dependent on species and, in rats, on dose. Hamsters excreted 90% of the dose in urine. Rats excreted 55 to 60% of the dose in feces after the low dose and 55 to 70% in urine after the high dose, suggesting possible saturation of biliary excretion. Repeated administration of the low dose to male rats did not alter the routes of excretion compared to a single dose. Major metabolites present in urine and bile were the glucuronide conjugates of gemfibrozil, the 4'-ring hydroxylated metabolite, and the meta-benzoic acid metabolite. The extensive urinary excretion of radioactivity by hamsters and enterohepatic recycling in rats suggests that rats were exposed to a much higher effective dose of gemfibrozil, which may in part explain the previously reported species differences in gemfibrozil-induced toxicity.
online pharmacy ref source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9884323&dopt=Abstract
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