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At least 19 recordsLinked to original sources

Utility of oxidation-reduction reaction for the determination of ranitidine hydrochloride in pure form, in dosage forms and in the presence of its oxidative degradates.

Three simple, accurate and sensitive colorimetric methods (A, B and C) for the determination of ranitidine HCl (RHCl) in bulk sample, in dosage forms and in the presence of its oxidative degradates are described. The first method A is based on the oxidation of the drug by N-bromosuccinimide (NBS) and determination of the unreacted NBS by measurement of the decrease in absorbance of amaranth dye (AM) at a suitable lambda(max)=520 nm. The methods B and C involve the addition of excess Ce(4+) and determination of the unreacted oxidant by decrease the red color of chromotrope 2R (C2R) at a suitable lambda(max)=528 nm for method B or decrease the orange pink color of rhodamine 6G (Rh6G) at a suitable lambda(max)=526 nm for method C. Regression analysis of Beer-Lambert plots showed good correlation in the concentration ranges 0.2-3.6, 0.1-2.8 and 0.1-2.6 microg ml(-1) for methods A, B and C, respectively. The apparent molar absorptivity. Sandell sensitivity, detection and quantitation limits were calculated. For more accurate results, Ringbom optimum concentration ranges were 0.3-3.4, 0.2-2.6 and 0.2-2.4 microg ml(-1) for methods A, B and C, respectively. Analyzing pure and dosage forms containing RHCl tested the validity of the proposed methods. The relative standard deviations were </=1.38 with recoveries 98.9-101.0%.

Bromides↗

Spectrophotometric determination of fenoterol hydrobromide in pure form and dosage forms.

A sensitive and rapid spectrophotometric procedure has been investigated for the determination of fenoterol either per se or in pharmaceutical preparations. The proposed procedure is based on the reaction between the drug and 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) at pH 7.2, using borate buffer, to produce a yellow adduct. The latter has maximum absorbance at 400 nm and obeys Beer's law within the concentration range 5-30 microg/ml. Regression analysis of the calibration data showed a good correlation coefficient (r=0.9996) with minimum detection limit of 0.24 microg/ml (6.2 x 10(-8) M). The proposed procedure has been successfully applied to the determination of this drug in its tablets and in syrup, the mean percent recoveries were 97.45+/-0.59 and 98.7+/-0.64%, respectively. The results obtained are in good agreement with those given using a reference method. The pharmaceutical additives other than active ingredient did not interfere. A proposal of the reaction pathway has been postulated.

4-Chloro-7-nitrobenzofurazan↗

[Gastroretentive dosage forms].

Gastroretentive dosage forms are drug delivery systems which remain in the stomach for an extended period of time, and allow both spacial and time control of drug liberation. Their application can be advantageous in the case of drugs that are absorbed mainly from the upper part of the gastrointestinal tract or are unstable in the medium of distal intestinal regions. They can also be used beneficially in the local therapy of the stomach. Because of the complicated and by many factors influenced physiology of this organ, the design of such delivery systems is a task requiring due foresight and knowledge. Gastroretentive dosage forms can be floating, expandable, bioadhesive, modified shape and high density systems according to the physical property leading to prolongation of gastric residence time. Combinations of the listed categories can occur as well. Several spirited ideas and solutions have come up in the literature for the preparation of such delivery systems, but there is still need for development in the field of implementation and prediction of in vivo behaviour before these dosage forms can be elemental part of clinical practice.

Administration, Oral↗

Voltammetric study of salbutamol and application to its determination in a tablet dosage form and dissolution profiles for the dosage form.

The oxidative voltammetric behaviour of salbutamol at a glassy carbon electrode surface has been studied using cyclic voltammetry and differential pulse voltammetry. Oxidation of the drug was effected in a single irreversible, adsorption-controlled step in phosphate buffer. The process was found to be dependent on the ionic strength and the pH of the supporting electrolyte. The response was evaluated with respect to accumulation time, scan rate and other variables. Using differential pulse voltammetry following electrochemical pretreatment of the electrode surface, the drug yielded a well-defined voltammetric response in phosphate buffer, pH 5.0, at +0.75 V (vs SCE). This process could be used to determine salbutamol concentrations in the range 8 x 10(-7) M to 8 x 10(-5) M with a detection limit of 2 x 10(-7) M. The method was applied, without any interferences from the excipients, to the determination of the drug in a tablet dosage form and in drug dissolution studies. The absolute recovery for salbutamol was greater than 95% at the concentration levels studied, and reproducible voltammetric signals were obtained with a relative standard deviation of 2.4% for n = 7 at a concentration level of 8 x 10(-5) M.

Adsorption↗

[Interaction between polyethylene films and bromhexine HCl in solid dosage forms. I. Effects of moisture contents in the solid dosage forms on the sorption of the drug].

The decrease of bromhexine HCl contents in granules and tablets was determined when the preparations were stored in polyethylene film package. Effects of temperature, contact area with film, excipients and moisture contents in the preparation on the remaining amount of bromhexin HCl were studied in order to investigate the interaction mechanism between bromhexine HCl and polyethylene film. It was observed that the decrease of bromhexine HCl was due to the sorption to the polyethylene film. The results indicated that the moisture contents of the dosage forms determined the rate of sorption predominantly, and that removal of adsorbed water from dosage forms was effective to prevent bromhexine HCl content decrease.

Adsorption↗

Evaluation of dosage forms. VI. Studies of commercial oxyphenbutazone tablet dosage forms.

Dissolution-dialysis studies of commercial tablets of oxyphenbutazone were carried out to establish the applicability of this technique for the in vitro evaluation of oxyphenbutazone dosage form. While disintegration time and dissolution rate studies did not give a true indication of bioavailability, an excellent correlation was obtained between the dialysis rate constant K and the pharmacokinetic parameters AUC and Cmax.

Anti-Inflammatory Agents, Non-Steroidal↗

Sustained release of hydrophobic and hydrophilic drugs from a floating dosage form.

Floating dosage forms enable the sustained delivery of drugs in the gastro-intestinal tract. In this study, a type of multi-unit floating gel bead was synthesized with calcium alginate, sunflower oil, and a drug of interest through an emulsification/gelation process. The alginate beads with oil addition were able to continuously float over the medium for 24h under constant agitation while the non-oily beads could not. Three kinds of drugs with different hydrophilicities, ibuprofen, niacinamide and metoclopramide HCl, were tested in the study. The hydrophobic drug ibuprofen was released in a sustained manner for 24h, due to the oil partitioning. With suitable modification, the beads were able to also release the hydrophilic drugs, niacinamide and metoclopramide HCl, for a similar duration. Therefore a floating dosage form that is able to sustain release both hydrophobic and hydrophilic drugs within its extended gastric retention time has been developed.

Alginates↗

Evaluation of dosage forms. IV. Studies on commercial phenylbutazone tablet dosage forms.

In order to determine the feasibility of dissolution-dialysis as a suitable technique for in vitro evaluation, studies on commercial phenylbutazone tablets were carried out. Although disintegration time and dissolution parameters did not give a true indication of bioavailability, an excellent correlation was obtained between the dialysis rate constant (K) and various pharmacokinetic parameters obtained from bioavailability studies on human volunteers.

Adult↗

Determination of paracetamol in pure form and in dosage forms using N,N-dibromo dimethylhydantoin.

Paracetamol (Acetaminophen) is one of the most frequently used analgesic drugs. At therapeutic dosage levels the drug is relatively non-toxic. Because of its increasing therapeutic use, its assay and quality control are of vital importance. A number of methods, including instrumental and titrimetric, are available for the quantitative determination of paracetamol in literature. A simple and accurate titrimetric method has been developed for the assay of paracetamol in pure form and in dosage forms, using N,N-dibromo dimethylhydantoin (DBH). Though a number of N-halo compounds are available for the determination of pharmaceuticals, DBH has greater advantages over such reagents.

Acetaminophen↗

Over-the-counter pharmaceuticals: exploratory research of consumer preference toward solid oral dosage forms.

The capsule dosage form in nonprescription pharmaceuticals persists as being one of the most vulnerable to product tampering. This study examines consumer preference toward three solid oral dosage forms (capsules, caplets, and tablets) in nonprescription products. Thirteen independent variables representing dosage form attributes are measured on semantic differential scales. The data are analyzed using analysis of variance (ANOVA) and factor analysis. Implications for the pharmaceutical marketer are noted. Future directions for research are also outlined.

Administration, Oral↗

Expandable gastroretentive dosage forms.

Expandable gastroretentive dosage forms (GRDFs) have been designed for the past 3 decades. They were originally created for possible veterinary use, but later the design was modified for enhanced drug therapy in humans. These GRDFs are easily swallowed and reach a significantly larger size in the stomach due to swelling or unfolding processes that prolong their gastric retention time (GRT). After drug release, their dimensions are minimized with subsequent evacuation from the stomach. Gastroretentivity is enhanced by the combination of substantial dimensions with high rigidity of the dosage form to withstand the peristalsis and mechanical contractility of the stomach. Positive results were obtained in preclinical and clinical studies evaluating GRT of expandable GRDFs. Narrow absorption window drugs compounded in such systems have improved in vivo absorption properties. These findings are an important step towards the implementation of expandable GRDFs in the clinical setting. The current review deals with expandable GRDFs reported in articles and patents, and describes the physiological basis of their design. Using the dog as a preclinical screening model prior to human studies, relevant imaging techniques and pharmacokinetic-pharmacodynamic aspects of such delivery systems are also discussed.

Animals↗