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At least 361 records · Page 20Linked to original sources
PubMed1998

[Ascolong: a new buccal dosage form of acetylsalicylic acid to be used and antiaggregant].

AIM: Study of the tolerance and pharmacodynamic and pharmacokinetic characteristics of ascolong, a new buccal dosage form of aspirin containing a very low dose of acetylsalicylic acid (ASA): 12.5 mg. MATERIALS AND METHODS: The study was carried out in 43 healthy men (assessment of the drug tolerance) and 19 male patients with coronary disease or cerebrovascular disorders. In 10 patients the antiaggregant efficacy of ascolong administered once or regularly (for 2 weeks) in a dose of 12.5 mg was compared with placebo, in 9 patients a random cross study of 2-week courses of ascolong and Russian aspirin tablets in a dose of 100 mg was carried out. Platelet aggregation was assessed on days 1 and 14 of each course before and 2, 4, and 24 h after the drug intake. RESULTS: Ascolong containing a very low dose of ASA exerts a reliable antiaggregant effect after a single and regular intake, although this effect is less manifest than after aspirin tablets. Profiles of ASA concentrations in the blood were studied. Transbuccal entry of ASA in systemic circulation decelerated its metabolism into a less active metabolite, salicylic acid, due to which fact the ASA microdose had an expressed antiaggregant effect. The drug was sufficiently well tolerated. CONCLUSION: The new buccal film form of aspirin containing a very low dose of ASA possesses a good antiaggregant effect and is promising in subjects with contraindications to oral intake of aspirin.

Administration, Buccal↗
PubMed1995

New oral dosage form for elderly patients: preparation and characterization of silk fibroin gel.

The pharmaceutical utility of silk fibroin as a possible material for an oral dosage form for elderly patients was investigated. Silk fibroin gel (SFG) was prepared from its aqueous solution. The gel formation was studied as a function of adjusted pH and concentration of silk fibroin (SF). On the basis of Fourier transform infrared spectroscopy of SFG, the transition from the random coil to the beta-structure was observed. The rate of gelation was sufficiently accelerated by the addition of glycerol to the SF aqueous solution. The glycerol content also affected the rate of gelation of the SF solution. Rheological properties of SFG were evaluated using a creep meter. The SF content and/or glycerol content affected the breaking stress of SFG. Moisture desorption from SFG was retarded with an increase in glycerol content. It was found that SFG was able to be prepared at room temperature (20 +/- 5 degrees C), and the SF content and glycerol content affected the formation and physicochemical properties of SFG.

Administration, Oral↗
PubMed1994

Release of isosorbide dinitrate from polymer film dosage forms and absorption of this drug through the oral mucosa of rats.

In vitro release tests and in vivo absorption measurements of oral cavity dosage forms of isosorbide dinitrate (ISDN) prepared from mixed polymer film systems were conducted. Hydroxypropylcellulose (HPC) and hydroxypropylmethylcellulose phthalate (HPMCP) were used to make the films, and the tests were conducted with films made from various ratios of these two polymers. The effects of the addition of the accelerator glycyrrhizic acid (GL), on dissolution and absorption were also examined. The mean dissolution time (MDT) in the in vitro dissolution tests varied with the nature of the polymers and drug, as well as with the pH of the testing solution. The MDT for the polymer film system with GL was smaller than that without GL. In the in vivo absorption tests using rats, the absorption of ISDN through the oral mucosa was observed in all the systems. In the mixed polymer film systems, the mean residence time (MRT) increased with increasing the ratio of HPMCP/HPC. The values of the area under the curve (AUC) for the systems with GL was larger than for those without GL. A good correlation was demonstrated between the absorption rate constant, ka and the dissolution rate constant, kd.

Absorption↗
PubMed1987

High-performance liquid chromatographic determination of Tornalate in solution dosage forms; a specificity study.

A reversed-phase high-performance liquid chromatographic method has been applied utilizing ion-pairing to measure Tornalate in solution dosage forms. Specificity of the method was demonstrated by selectivity for Tornalate analysis, analysis of stressed samples and by peak homogeneity tests. These included the diode-array derived spectral overlay test and fraction collection with rechromatography in an alternate normal phase system. Linearity was also demonstrated in terms of recovery from synthetic samples and detector response.

Chromatography, High Pressure Liquid↗
PubMed1994

HPLC determination of sodium cromoglycate in pharmaceutical dosage forms.

A reversed-phase high-performance liquid chromatography (HPLC) method is described for the determination of sodium chromoglycate (SCG) in bulk drug and pharmaceutical dosage forms (capsules, solutions, gels). Aliquots were chromatographed on C18 columns using methanol: phosphate buffer (50:50 v/v) at pH 2.3 as the mobile phase. Detection was performed at 326 nm with a linear range of 0.05-0.5 microgram/ml (r = 0.9999). Recovery values ranged from 99.21 to 106.31% (N = 9). The proposed method is rapid and simple, free from interference by excipient and degradation products, and can be recommended for routine control analysis of sodium chromoglycate commercial products and magistral formulations.

Chromatography, High Pressure Liquid↗
PubMed2005

Determination of tramadol hydrochloride in ampoule dosage forms by using UV spectrophotometric and HPLC-DAD methods in methanol and water media.

Two newly developed simple and sensitive methods for determination of tramadol hydrochloride in ampoule dosage forms were described and validated. Measurements for spectrophotometric method were performed using UV-Vis Spectrophotometer in ranges of 200-400 nm. The solutions of standard and the samples were prepared in methanol and water media and the UV absorption spectrums of tramadol were monitored with maximum absorptions at 275 and 271 nm for both mediums, respectively. The standard calibration curves of tramadol were constructed by plotting absorbance vs. concentration in the concentration range with the final dilution of 10-100 microg ml-1. Reversed phase chromatography for HPLC method was conducted using a Phenomenex Bondclone C18 column with an isocratic mobile phase consisting of 25% acetonitrile in 75% 0.01 M phosphate buffer (pH 3). The effluent was monitored on a DAD detector at 218 nm. Linear response (r>0.99) was observed over the range of 0.5-40 microg ml-1 for methanol and water and run on six different occasions. The methods were applied successfully to pharmaceutical ampoule forms, but also for comparison in two different solvent media. Besides, it was completely validated and proven to be rugged.

Acetonitriles↗
PubMed1978

Influence of food on the absorption of acetylsalicylic acid from enteric-coated dosage forms.

The absorption of acetylsalicylic acid (ASA) from two different enteric-coated dosage forms, tablets (Premaspin) and granules (Reumyl), was studied in healthy volunteers under fasting and non-fasting conditions by following the plasma concentration and urine recovery of salicylates after single doses of ASA 1 g. Conventional tablets (Aspirin) were used as the reference. Under fasting conditions the absorption of ASA from the two different enteric-coated preparations was complete. Taken with food the enteric-coated tablets gave much lower plasma concentrations than under fasting conditions, and absorption was not complete in all subjects. In contrast, absorption from the enteric-coated granules was not influenced by the intake of food. It was concluded that enteric-coated granules of ASA permit more reproducible absorption than enteric-coated tablets.

Adult↗
PubMed1998

Electrochemical reduction of metronidazole at activated glassy carbon electrode and its determination in pharmaceutical dosage forms.

A voltammetric method has been developed for the determination of metronidazole in dosage forms. The method is based on the electrochemical reduction of the drug at a glassy carbon electrode activated by applying a new pretreatment. The influence of pH, concentration, scan rate and presence of organic solvent and surfactant has been studied. The current is proportional to the concentration and permits the drug to be determined in the concentration range 2 x 10(-6)-6 x 10(-4) M in Britton-Robinson buffer (pH 10). Furthermore, results obtained by the proposed method have been compared with USP XXIII procedure which involves a HPLC method.

Antitrichomonal Agents↗
PubMed1994

Bioequivalence of two oral dosage forms prepared from different polymorphic modifications of tenoxicam.

The bioavailability of two pharmaceutical dosage forms formulated using different polymorphs of tenoxicam were compared. Serum levels of TNX were analysed using high performance liquid chromatography. The pharmacokinetic parameters were estimated following the oral administration of a single dose (20 mg) of the drug as two different polymorphs to 12 healthy volunteers. The differences between formulations were statistically insignificant.

Administration, Oral↗
PubMed2006

Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA) problems were also taken into consideration. On the basis of the overall evidence, a biowaiver can be recommended for cimetidine IR products, provided that the test product contains only those excipients reported in this paper in their usual amounts, and that the test and the comparator drug products both are "rapidly dissolving" as per BCS.

Administration, Oral↗
PubMed2002

Simultaneous high-performance liquid chromatographic determination of paracetamol, phenylephrine HCl, and chlorpheniramine maleate in pharmaceutical dosage forms.

A rapid, precise, and specific high-performance liquid chromatographic method is described for the simultaneous determination of paracetamol, phenylephrine HCI, and chlorpheniramine maleate in combined pharmaceutical dosage forms. The method involves the use of a microBondapak CN RP analytical column (125 A, 10 microm, 3.9 x 150 mm) at 22 degrees C as the stationary phase with the mixture of acetonitrile and phosphate buffer (pH 6.22, 78:22) as the mobile phase. Derivatization of the drugs is not required. The method is applied to commercial pediatric cough-cold syrups, tablets, and capsules marketed in Turkey. The relative standard deviation for 10 replicate measurements of each drug in the medicaments is always less than 2%.

Acetaminophen↗
PubMed2006

Biowaiver monographs for immediate release solid oral dosage forms: amitriptyline hydrochloride.

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing amitriptyline hydrochloride are reviewed. Its therapeutic uses, its pharmacokinetic properties, the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. Literature data indicates that amitriptyline hydrochloride is a highly permeable active pharmaceutical ingredient (API). Data on the solubility according to the current Biopharmaceutics Classification System (BCS) were not fully available and consequently amitriptyline hydrochloride could not be definitively assigned to either BCS Class I or BCS Class II. But all evidence taken together, a biowaiver can currently be recommended provided that IR tablets are formulated with excipients used in existing approved products and that the dissolution meets the criteria defined in the Guidances.

Administration, Oral↗
PubMedDate not supplied

Pharmacokinetic data processed by microcomputer for the formulation of optimal drug dosage form.

Microcomputers have been used in pharmacokinetics for several years, but their use in the area of formulation is a new application. By using appropriate data on the drug, the dosage form required and its mechanism of absorption and clearance, microcomputers can systematize and speed-up formulation, simplify manufacturing processes and, through simulated models and plasma level predictions, reduce the number of bioavailability studies needed.

Biological Transport↗
PubMed1997

Identification of drugs in pharmaceutical dosage forms by X-ray powder diffractometry.

A simple X-ray powder diffractometric (XRD) method was developed for the identification of the active ingredient in a variety of dosage forms. The method was successfully used to unambiguously identify the active ingredient(s) in tablet, capsule, suppository and ointment formulations. The unique feature of the method is that it provides information about the solid-state of the drug. Thus, a capsule formulation containing anhydrous ampicillin was readily distinguished from that containing ampicillin trihydrate. The USP stipulates the use of the beta-polymorphic form of anhydrous carbamazepine in carbamazepine tablets. Contamination by the alpha-polymorph (down to a level of 1.4% w/w of the formulation) could be detected. In some of the multicomponent formulations, there was a pronounced overlap of the powder patterns of ingredients which made identification difficult. This problem was solved by using a pattern subtraction technique, which permitted selective subtraction of the XRD pattern of the constituents of the formulation from the overall XRD pattern. Such an approach enabled identification of the drug even when it constituted only 5% w/w of the formulation. The method also permitted simultaneous identification of the multiple active ingredients in trimethoprim-sulfamethoxazole and acetaminophen-aspirin-caffeine formulations.

Capsules↗
PubMed2002

Pharmacokinetics of lovastatin extended-release dosage form (Lovastatin XL) in healthy volunteers.

The purpose of this study was to evaluate pharmacokinetics and dose proportionality of lovastatin extended-release dosage form (ER-lovastatin) in the dosage levels of 10, 20 and 40 mg in 9 healthy male subjects. Each subject was randomized to receive a single oral dose of ER-lovastatin either 10, 20 or 40 mg in a three-way crossover design with a washout period of 7 days between the treatments. Subjects were served dinner at approximately 5:30 PM followed by dosing at approximately 10:00 PM in each study period. Serial plasma samples were collected up to 48 h after dosing and assayed for lovastatin and its active metabolite lovastatin acid using an LC/MS/MS method. The plasma concentration-time profiles of lovastatin and its active metabolite lovastatin acid exhibited delayed- and extended-release characteristics at each dose. Mean (+/-) values for the C(max) of lovastatin were 1.04+/-0.43, 2.03+/-0.65 and 4.03+/-3.02 ng/ml for the 10, 20 and 40 mg dosage, respectively. The corresponding values for the AUC(0-48 h) of lovastatin were 14.6+/-7.8, 34.1 +/-13.7, and 53.9+/-35.6 ng h/ml. The same tendency was also found for C(max) and AUC(0-48 h) values of lovastatin acid. Results from this study demonstrated as the dose of ER-lovastatin increased from 10 to 40 mg, the C(max) and AUC(0-48 h) values of lovastatin as well as lovastatin acid appeared to increase linearly.

Adult↗
PubMed2002

Spectrophotometric and fluorimetric methods for the determination of meloxicam in dosage forms.

Four simple and accurate methods are presented for the determination of meloxicam in dosage forms. These methods are based on: the direct measurements of the differential spectra at 339.9-384.7 nm (A), the 1D-values at 322-368 nm and 2D-values at 343.2-385.6 nm (B), the formation of an ion-association complex between the drug and safranin T with subsequent absorption measurement at 518 nm (C) and fluorescence measurement at 582 nm (D). All variables were studied to optimize the formation of the ion-association complex. Beer's law was valid over the concentration range 2-10 microg ml(-1) (method A), 1-10 microg ml(-1) (method B), 4.0-12 microg ml(-1) (method C) and 0.4-1.2 microg ml(-1) (method D). The detection limits were 0.11, 0.07, 0.10, 0.33 and 8.74 x 10(-3) microg ml(-1) for methods A, B, C and D, respectively. The proposed methods were successfully applied to the assay of meloxicam in tablets and suppositories. The procedures were rapid, simple and suitable for quality control applications.

Anti-Inflammatory Agents, Non-Steroidal↗