Objective of the proposed method was to develop a simple, fast, sensitive, and validated HPLC method for the simultaneous estimation of metformin and vildagliptin in tablets and human plasma by high-performance liquid chromatography. The chromatographic separation was accomplished with a fast monolithic column using a mixture of sodium dihydrogen phosphate and sodium dodecyl sulfate and acetonitrile at pH 4.5 as the mobile phase. Additionally, newly developed method was validated as indicated by ICH guidelines. The method showed good correlation coefficients (r ≥ 0.997) in the range of 0.05–20 µg/mL and 0.1–40 µg/mL for metformin and vildagliptin respectively. The accuracy and intraday and interday precision results were within the acceptable range for both analytes. Further, for determination of the drugs in human plasma, the samples were prepared by protein precipitation with acetonitrile. The mean extraction recoveries of metformin and vildagliptin from human plasma were 97.51 % and 97.18 % respectively. The simple, rapid, sensitive, robust and validated analytical method developed was used for simultaneous estimation of metformin and vildagliptin in formulation and in patient plasma.
Key words: Formulation, HPLC, Metformin, Plasma, Simultaneous determination, Validation, Vildagliptin,
The treatment of diseases or disorders using mono-drug therapy is found to be less effective when compared with combination therapy. In general, regulatory agencies such as the US Food and Drug Administration recommend the prescription of combination therapy, and particularly for the treatment of chronic diseases such as diabetes and hypertension. Consequently, pharmaceutical industries have initiated and developed a wide variety of drug co...
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...e HPLC and liquid chromatography–tandem mass spectrometry methods for estimation of MET alone [16, 17, 18, 19, 20, 21, 22] and in combination with other drugs. Few analytical methods are documented in the literature for determination of VLD in solid dosage forms [23, 24] or in plasma [25, 26]. Recently, three HPLC methods were illustrated for the simultaneous determination of VLD and MET in formulations [27, 28, 29]. However, existing methods suffer from a number of disadvantages, such as low sensitivity, and internal standards have not been used to date. Hence, the current study focused on the development of a fast, sensitive, and high-throughput analysis using an HPLC method for simultaneous estimation of MET and VLD in formulations and human plasma. To our knowledge, the anticipated method is the first to allow simultaneous determination of MET and VLD in plasma.
This paper discusses pharmacology and terminology related to “Pharmacology” which is the branch of medicine concerned with the uses, effects, and modes of action of drugs“ pharmacology. 2015. In Merriam-Webster.com. The study of different classes of drugs, routes of absorption, and drugs have effects on those consuming them. There are drugs that are necessary for illnesses and healing but, there are medicines that cause concern regarding interaction and harming the body.
Aspirin has grown so much in popularity that about 35,000 metric tons of it is produced and consumed each year to meet the consumer’s demand. 35,000 metric tons is equivalent to 100 billion standard aspirin tablets (10). That many tablets means that the market for aspirin is very good. Today, Aspirin is known as the leading non-prescription medicine of all time. It is the most common pill taken for pain, inflammation and fever. It has grown all over the world, being made available in eighty countries (9). It would not be surprising if one day, all the countries would have aspirin available to them.
The capabilities of Abbvie in developing and innovating therapies, nutritional products, medical products and life-changing products to patients needing the most have recognized Abbvie as a top notch pharmaceutical leader. The projects undertaken with the technology and scientific advancements at Abvie demonstrate a greater level of Leadership qualities in administering, delivering and managing such high volume of products, sales, commercial, supply chain management systems etc.
Blockbuster drugs are usually a significant therapeutic breakthrough compared to previously available therapies. However greater therapeutic value alone is not enough for cr...
Metformin is the generic name of a medication used in the management of diabetes mellitus type 2. Various trade names of this drug include Riomet, Glucophage XR, Carbophage SR, Obimet, Siofor, Fortamet, Glucophage, and Glumetza. The chemical name is 1,1-Dimethylbiguanide monohydrochloride. Doses up to 2000 mg per day may be given twice daily. The circulation of metformin is that the drug’s steady state of concentration within the blood is reached in 24-48 hours and the half life is approximately 6-1/2 hours. The nonabsorbed fraction of the dru...
...t compliance, and medication adherence is highly correlated with positive health outcomes. Thus, a medicine that maximizes patient adherence, delivers the same efficacy as previously used drugs, and shows no additional adverse effects is exceedingly likely to become the drug of choice. Of particular interest to researchers currently are the medications glyburide and metformin. As more and more research continues, it is hypothesized that these drugs will become part of the pharmaceutical regime in the treatment of gestational diabetes mellitus. In fact, both glyburide and metformin have been successfully prescribed to treat GDM in other countries for several years. Glyburide, especially, is predicted to gain the approval by the FDA in the coming years as, at least, a second line medication since it has shown to only cross the placenta in insignificant quantities.
Ostrove, N. M. (2004). Statement of Nancy M. Ostrove, Ph.D., Deputy Director, Division of Drug.
Adverse drug events or medication errors that result from polypharmacy can often be difficult to predict and prevent. According to an article posted in the American Journal of Health-System Pharmacy (2012), drug –drug interactions may lead to increased toxicity levels when taken together. An example is the interactio...
Polypharmacy is the “concurrent use of several differ drugs and becomes an issue in older adults when the high number of drugs in a medication regimen includes overlapping drugs for the same therapeutic effect”(Woo & Wynne, 2011, p. 1426). The patient is currently taking several medications that can potential interact with each other, perform the same therapeutic effect, and creating side effects. The following is a list of her medications and their indications:
To continue, compounding would be needed if a patient wants to change something about the medicine such as flavor or strength. It is vital that s...
As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b...
Lasix is known as the “water pill” it’s a diuretic administrated orally.(1) The active ingredient of Lasix is furosemide, but also includes a number of inactive ingredients including lactose monohydrate NF, magnesium stearate NF, starch NF, talc USP, and colloidal silicon dioxide NF. (1) The peak effects of furosemide are typically seen within the first hour of two after a dose of the medication. (1). Lasix is prescribed for individuals to treat edema that may arise from congestive heart failure, liver cirrhosis or renal disease. (1) In adults, furosemide may also be taken to treat hypertension itself.(1) Furosemide comes in 20, 40, and 80mg tablets as well as oral suspensions.(2) Furosemide is absorbed rapidly from oral suspension at 50 minutes, and from tablets at 87 minutes.(2) Food may slow down the absorption of the drug and alter the bioavalibitly.(1) Furosemide binds to plasma proteins, albumin being the main plasma protein that furosemide binds to, at 91-99%, and peak plasma concentrations increase with the increase of a single dose.(2) Furosemide is excreted through the urine and the remainder is excreted in the feces. (2) The half-life for furosemide is approximately 2 hours but the diuretic effects last 6-8 hours. (2)
According to Pham and Dickman (2007), polypharmacy is described as an overuse of multiple medications (pg. 1840). There is no established number of medicines necessary on a patients profile in order to be deemed polypharmacy (Pham and Dickman, 2007), however it is known that patients taking multiple medications are at greater risk for adverse drug reactions. The elderly and children make up the high risk groups that providers should reevaluate the mediation profiles to ensure any patients with renal insufficiencies do not have drug therapies that continue beyond the point of benefit (Woo and Wynne, 2012). The concept involves the idea that the more medicines a patient takes the greater risk of drug interaction and adverse drug events (Pham and Dickman, 2007).
Metformin is a biguanide which is an effective oral anti hyperglycemia drug which is widely used to control type II diabetes mellitus and more recently in pregnancy. (7)
Bioavailability is the fraction of the dosage form that reaches systemic circulation after any route of administration. In this particular study, acetaminophen was administered orally, intravenously, and rectally in healthy men aged 18 to 45 and the pharmacokinetic parameters were compared for each route. The study assumed IV bioavailability to be 100%. The bioavailability of the oral dose was 89% and 72% for the rectal dose. Drug interactions, intestinal motility, gastric pH, and stomach emptying can all alter absorption. In this study, there were key exclusion criteria implemented to try to minimize the risk of these factors influencing the results. For example, this study was limited to healthy males weighing at least 50 kilograms and testing negative for any immunodeficiencies. This would ideally eliminate factors that can alter absorption like any disease states. All participants were also non-smokers. Some studies have shown that chronic smoking can increase acid secretion in the stomach, so by eliminating smokers from this study the chance that gastric pH affecting the results was minimized. Lastly, the use of any medications or supplements in the 7 days prior to the first dose of acetaminophen administered was not allowed. In addition, during the 3 day length of the study, no other medications were allowed to be administered. These factors together removed the chance of drug interactions affecting the pharmacokinetics of acetaminophen.