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Tis reduction in mean body (a) Pharmacokinetics of single doses weight was apparently secondary to suppression 14 Pharmacokinetic studies using [ C]hydro- of food intake discount ipratropium 20 mcg mastercard 20 medications that cause memory loss, but was not clearly dose-related purchase ipratropium cheap online medicine xarelto. Tis was consistent with a previous was due to procedural diferences order generic ipratropium permatex rust treatment, for example generic 20 mcg ipratropium medications related to the blood, report from Beermann & Groschinsky-Grind difering doses used, and variation in times (1977), who used gas-liquid chromatography when food was permitted afer dosing. Absorption from all doses was and non-fasting subjects were permitted food rapid; peak plasma concentrations were achieved 4 hours afer dosing in the later study (Barbhaiya at approximately 2 hours. Tus, the doses, is approximately 40% bound to plasma bioavailability of hydrochlorothiazide did not protein, and accumulates in erythrocytes. Te appear to difer between diferent oral prepara- ratio of uptake between erythrocytes and plasma tions (Beermann, 1984). Absorption of hydrochlorothiazide is gener- Equilibrium of hydrochlorothiazide between ally considered to follow frst-order kinetics plasma and erythrocytes is reached 4 hours (Barbhaiya et al. In a study reporting increased and duodenal bile, and showed that the main absorption in the presence of food (Beermann excretory route of hydrochlorothiazide was via & Groschinsky-Grind, 1978b), the mean urinary the kidneys. Mean renal clearance was approxi- recovery of an oral dose of 75 mg of hydrochloro- mately 300 mL/minute. Tere was no reabsorp- thiazide in eight subjects, under both fasting and tion (Beermann et al. In contrast, a study organic anion transport system at the proximal of eight healthy volunteers each given 50 mg tubules (Beermann et al. Concentrations of this metabolite were Te urinary excretion rate closely resembled this higher (4. Te plasma in patients’ urine 24 hours afer taking hydro- elimination half-life was about 6 hours initially, chlorothiazide than in the same batch of bulk but up to 15 hours terminally (Barbhaiya et al. Radiographic metabolite, chlorothiazide, were detected in the analysis of urine extracts (n = 110) collected from urine by liquid chromatography-mass spectrom- fve healthy subjects and three patients given etry 120 hours afer administration (Deventer [14C]hydrochlorothiazide orally revealed a single et al. However, two samples from one subject collected on the second and third (i) Pregnancy days afer dosing revealed some radiolabelled A study of 10 pregnant women given a daily material (< 0. Te nature of this sion) demonstrated that the diuretic crossed the material was found by Okuda et al. Hydrochlorothiazide substantial reduction in the extent and rate of was not however detectable (detection limit, absorption of hydrochlorothiazide (recovery of 20 ng/mL) in the blood of the nursing infant only 21–37% of the administered dose in three (Miller et al. Since the reduced in the extent and rate of elimination of hydro- intestinal mobility shown in cardiac failure chlorothiazide; only about 10% of an oral dose would be expected to promote the uptake of was recovered, and the elimination half-life hydrochlorothiazide, the observed decrease in was increased from a mean value of 6. Tese patients absorption was considered not to be reduced in were older than those studied previously (age, these patients, since the area-under-the-curve 40–60 years), and it was considered that reduced values were greater in those with low creatinine renal function and age may have been factors clearance than in healthy subjects. In patients in the reduction of absorption (Beermann & with severe renal impairment, the elimination Groschinsky-Grind, 1979). Analyses of serial fve patients who received an oral dose of hydro- samples of blood and urine collected over 36 chlorothiazide of 775 mg (at times ranging from hours demonstrated that the pharmacokinetics 1. No signifcant pharmacokinetic interactions (a) Mutagenicity have been noted between hydrochlorothiazide Te Working Group did not identify any new and propranolol, metoprolol, sotalol, or acebut- data on the mutagenicity of hydrochlorothiazide olol. In two studies, hydro- spironolactone and indomethacin, allopurinol chlorothiazide was not mutagenic to Salmonella and its metabolite, oxipurino1, and phenytoin typhimurium in the presence or absence of an (Welling, 1986). Hydrochlorothiazide was triamterene as components of a fxed drug not mutagenic in bacterial screening systems, combination revealed diferences in bioavaila- with or without enzymatic activation, but can bility from combination tablets and capsules, but form chemically reactive mutagenic products subsequent work suggested that these diferences afer reaction with nitrite, a product of nitric may have been due to the efects of formulation oxide (Andrews et al. Tis was proposed to be because hydro- an arg– strain of Escherichia coli (Hs30R) (Fujita, chlorothiazide does not undergo metabolism in 1985). Clinical evidence also indicates that hydro- (b) Chromosomal damage chlorothiazide can act as a photosensitizer in Chromosomal damage caused by hydro- the presence of irradiation by ultraviolet A or chlorothiazide was reviewed by a previous ultraviolet B (Addo et al. In a phototoxic exanthem is “occasional” (> 1/1000 to spot test, hydrochlorothiazide did not induce < 1/100) (Rote Liste Service GmbH, 2012) nondisjunction and mitotic crossing-over in Aspergillus nidulans (Bignami et al. Chromosomal aberrations were not found in Chinese hamster lung cells, but polyploidy 5. Summary of Data Reported was observed afer treatment with hydrochloro- thiazide for 48 hours (Ishidate et al. Hydrochlorothiazide is a thiazide-based Hydrochlorothiazide was found to induce diuretic that is recommended as a frst-line micronucleus formation and chromosome therapy for hypertension. Most frequently, breakage in cultured human lymphocytes via hydrochlorothiazide is used with other drugs that chromosome delay (Andrianopoulos et al. Efect modifcation by sun exposure is potentially important, but had not been thor- 5. Te case–control lacked dose–response relationships, or gave study from Denmark reported an excess risk of results that were close to unity. Tis was followed by a nested case–control also found an increased risk of renal cell carci- study of cancer of the lip in the same population, noma among women with unspecifed thiazide which reported a statistically signifcant twofold use. Tis association was difcult to interpret increase in risk for three or more prescriptions, owing to potential confounding by hypertension, and increasing odds ratios with duration of use. Tis was the only study with adequate statistical Two case–control studies on cancer of the power to assess use of hydrochlorothiazide alone. Evaluation carcinoma (combined) in male mice; there were no signifcant increases in the incidence of any 6. In the second study, there was an increased incidence of adrenal Tere is limited evidence in humans for the pheochromocytoma in female rats. Positive cant increase in the incidence of any neoplasm associations were observed for squamous cell was observed in male rats in the second study, carcinoma of the skin and lip. Hydrochlorothiazide increased the frequency of sister chromatid References exchange, but not chromosomal aberration, in Chinese hamster ovary cells, both in the presence Abdel Razak O (2004). In-vitro induction of micronucleus Intrahepatic distribution of hydrochlorothiazide and formation and chromosome breakage via chro- quinidine in rats: implications in pharmacokinetics. Tiazide- In the presence of ultraviolet A irradiation, induced photosensitivity: a study of 33 subjects. Genotoxicity of hydrochlorothiazide in 314 Hydrochlorothiazide cultured human lymphocytes. Malabsorption of hydrochlorothiazide Prevention, Detection, Evaluation, and Treatment of following intestinal shunt surgery. Pharmacokinetics of hydrochlorothiazide Detection, Evaluation, and Treatment of High Blood in fasted and nonfasted subjects: a comparison Pressure. Eur J Clin Pharmacol, for skin cancer in European populations: a multicentre 13(5):385–7. Arginine reversion and lambda induction Programme on Chemical Safety, World Health in E. Trends in antihy- porter 1 protein is induced by chronic furosemide or pertensive medication use and blood pressure control hydrochlorothiazide infusion in rat kidney. Nephrol among United States adults with hypertension: the Dial Transplant, 18(8):1505–11. Diuretics for hypertension–an Hallas J, Christensen R, Andersen M, Friis S, Bjerrum L inconsistency in primary care prescribing behaviour.
In contrast purchase ipratropium 20 mcg otc treatment bee sting, as discussed above purchase ipratropium amex symptoms checklist, the buccal route is: • relatively less permeable than the sublingual route; • does not generally give the rapid onset of absorption seen with sublingual delivery; • highly suited to retentive systems trusted 20 mcg ipratropium treatment 2 go. Specific physicochemical properties of the various dosage forms are discussed below purchase genuine ipratropium on-line treatment uterine cancer. A brief overview of both the advantages and disadvantages of oral transmucosal drug delivery is given below. This accessibility obviates the need for complex delivery devices to enable the drug to reach its absorption site. Thus devices for oral delivery are simpler in design than those intended to deliver drugs to, for instance, the alveolar region of the lung. Ease of use Oral transmucosal devices, such as sprays, tablets or patches, are also simple for the patient to use and might be expected to be more acceptable to the patient than the use of pessaries or suppositories for the intravaginal and rectal delivery routes respectively. Rich blood supply The highly vascular surface of the oral mucosa ensures rapid absorption and onset of action, as well as the maintenance of sink conditions. The buccal cavity offers the combined advantages of a relatively rapid onset of action, with the potential for sustained delivery over several hours. Furthermore, this route avoids first-pass effects of degradation in the intestinal wall or the liver, prior to the drug reaching the systemic circulation. Low variability This route has less variability than, for example, the oral route, where factors such as intestinal motility, presence of food and extremes of pH combine to make oral drug delivery highly variable. However, factors such as salivary flow and certain disease states can contribute to a degree of variabiliy associated with this route. Robust The oral mucosa is routinely exposed to a multitude of different foreign compounds and is relatively robust and less prone to irritation than, for example, the nasal mucosa. Prolonged retention Prolonged retention of the drug is possible in the buccal cavity, if the appropriate delivery system is used. Intestinal alternative The buccal cavity is a useful alternative to the intestinal route for drug absorption in situations where the gastrointestinal route is unfeasible. Examples include: • patients with nausea and vomiting; • patients with swallowing difficulties; • drugs that cause gastric irritation; • drugs that are unstable in the gastrointestinal fluids; • drugs that undergo extensive first-pass effects in the gut wall or liver. Zero-order controlled release Buccal drug delivery offers the potential to achieve zero-order controlled release. However, as described above, the oral epithelium is relatively robust and this factor is not as limiting as in other highly sensitive mucosal sites, such as the nasal cavity. Mucus and salivary clearance Mucus and salivary clearance reduces the retention time of drugs within the oral cavity and thus the opportunity for absorption. Mucus barrier Drug diffusion may be limited by the physical barrier of the mucus layer and also the specific or non- specific binding of drugs to the mucus layer. Patient acceptance A buccal patch comprises a relatively novel dosage form, which is placed in an unconventional drug delivery site. As such, there may be difficulties encountered in trying to get patients to accept this route. It can be imagined that patients may be more reluctant to use a buccal patch in comparison to, for example, a transdermal patch, which has become a well-known and well-established dosage form. Commercial Novel approaches, such as the use of buccal adhesive patches for the systemic delivery of large molecular weight drugs, require a huge input of time, effort and money, and are also associated with a large amount of risk. These issues can contribute to significant delay in the development and marketing of a new delivery system and can also make these systems relatively expensive. In sublingual tablet form nitroglycerin is highly effective, usually relieving the pain within 2 min of dissolution. Sublingual tablets are composed of soluble excipients (lactose, mannitol, sucrose) to achieve fast dissolution and thus aid rapid onset of drug action. However, the time taken to dissolve can be variable and prolonged, particularly in the presence of mouth dryness. Furthermore, the tablets have stability 179 problems and extreme care must be taken to avoid their exposure to heat, light, moisture and inappropriate packing material, which leads to a requirement for the tablets to be discarded 8 weeks after opening. Lipid aerosol formulations of nitroglycerin are also available, which are far more stable than the tablets, with a prolonged (3-year) shelf life. Sprayed directly onto the tongue, they produce relief of anginal pain within 2 min with a duration of effect of up to 30 min. However, it has been shown that the use of different aerosol vehicles markedly influences the bioavailability of the drug, which obviously has important therapeutic implications. Fast-dissolving molded tablets consisting of drug and poly(ethyleneglycol) blends with a melting point around the body temperature have also been investigated for the delivery of nitroglycerin and progesterone. Recently, fast-dissolving tablets based on freeze-drying techniques have been developed and are described further below. Oral bioavailability is very low, due to extensive intestinal and hepatic firstpass metabolism. Furthermore, the oral route is impractical in patients with nausea and vestibular disturbance, who have been demonstrated to have impaired gastric emptying. Buccastem tablets are a form of prochlorperazine for buccal administration, containing 3 mg of prochlorperazine in a polysaccharide base. When placed in position the tablet softens over a period of a few minutes to form a gel which adheres to the gum and gradually releases the drug. Prochlorperazine fulfils the criteria for efficient transmucosal delivery; it is a highly lipid soluble base with a pKa of 8. Because first-pass metabolism is avoided, the bioavailability via the buccal route is much higher than via the oral route (Figure 7. By contrast, oral long-acting nitrates have a prolonged but slow onset of action, restricting their use to angina prophylaxis. Sustained release buccal nitroglycerin (Suscard Buccal) was developed to provide both a rapid onset and a prolonged effect, in a single formulation. On contact with the moist mucosa the outer layer of the tablet hydrates and swells, becoming gel-like in consistency. This has the dual effect of: • promoting firm adherence of the tablet to the mucosa; • causing the outer layer of the cellulose meshwork to rupture, immediately releasing some of the drug for absorption. Gradual erosion of the tablet matrix allows slow release of the entrapped active moiety. Release from this system has been shown to be linear throughout the period of tablet dissolution. The high porosity of the system means that it dissolves instantaneously on the tongue and does not require water to aid swallowing. A number of products are currently available which use the Zydis technology including Dimetapp Quick Dissolving Tablets, Feldene Melt and Pepdine. However, it is important to note that the system does not actually facilitate oral transmucosal delivery per se, rather it allows rapid release of the drug in the mouth. The drug is then washed down with the saliva for subsequent absorption in the gastrointestinal tract. The convenience and acceptability of a Zydis formulation make it particularly suitable for patients who find it difficult or inconvenient to swallow solid dosage forms. In trials, up to 90% of patients expressed a preference for taking the Zydis formulation compared with a conventional tablet. Important features for drug delivery associated with these novel buccal patches include: 7.
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