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PubMed1979

High-performance liquid chromatography of two peripheral vasodilators, nylidrin hydrochloride and isoxsuprine hydrochloride, in pharmaceutical dosage forms.

A reliable and selective high-pressure liquid chromatographic (HPLC) procedure for the quantitative determination of nylidrin hydrochloride or isoxsuprine hydrochloride in pharmaceutical dosage forms is described. The specificity of the stability-indicating HPLC procedure is presented for nylidrin hydrochloride.

Chromatography, High Pressure Liquid↗
PubMed1982

Determination of ethinyl estradiol in solid dosage forms by high-performance liquid chromatography.

A rapid, reproducible high-performance liquid chromatographic system for the determination of ethinyl estradiol in solid dosage forms consisting of a reversed-phase column with a mobile phase of 0.05 M aqueous KH2PO4-methyl alcohol (2:3) and fluorescence detection has been developed. This stability-indicating method is applicable to tablets containing ethinyl estradiol alone or in combination with methyltestosterone and progesterones. The procedure has been used for the determination of ethinyl estradiol in single tablets, stability samples, and dissolution medium. Recovery of drug substance added to placebo was from 97.3 to 101.5% in stability and single-tablet assays, and 95.4 to 102.2% in dissolution assays. Reproducibility studies gave relative standard deviations of 0.4-2.2%.

Chromatography, High Pressure Liquid↗
PubMed1983

Quantitation of meperidine hydrochloride in pharmaceutical dosage forms by high-performance liquid chromatography.

A high-performance liquid chromatographic (HPLC) method for the quantitative determination of meperidine hydrochloride in pharmaceutical dosage forms was developed. The method is reproducible and precise with relative standard deviations (based on six readings) of 1.2% with hydroxyzine and 0.93% with hydroxyprogesterone caproate as the internal standards. A variety of other active and inactive ingredients which were mixed with meperidine hydrochloride did not interfere with the assay procedure. Among the ingredients tested were acetaminophen, atropine sulfate, disodium edetate, metacresol, phenol, promethazine, and sodium metabisulfite. This method appears to be stability-indicating since a hydrolyzed sample of meperidine showed zero potency and a new peak with a different retention time.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1999

Application of near-infrared spectroscopy in the pharmaceutical solid dosage form.

Near-infrared (NIR) spectroscopy, one of the most rapidly growing methodologies in pharmaceutical analysis, has been used to analyze the pharmaceutical solid dosage form. The objective of this study was to examine the information that can be gathered from NIR spectroscopy and demonstrate the potential utility of the technique as an alternative to current methods of tablet performance testing. The tablet formulation included active drug (acetaminophen or theophylline), binder (hydroxyethylcellulose), filler (lactose, calcium sulfate, dibasic calcium phosphate dihydrate, or microcrystalline cellulose), and lubricant (magnesium stearate). The compression forces were varied from 5 to 25 kN. A Foss/NIRSystems scanning near-infrared spectrometer was used to measure the diffuse reflectance from the tablet surface. Each tablet was scanned on opposite sides to reduce the effects of positioning. First derivative and multiplicative scatter correction data treatments were explored. A calibration for compression force, independent of the filler, was developed. In addition, the spectra were able to distinguish among the fillers used. A comparison of these spectra with data collected earlier suggests that the technique could differentiate among drugs as well. Near-infrared diffuse reflection spectroscopy, when properly calibrated, can determine the compression force used to prepare a tablet. This measurement may be independent of the different active drugs or fillers used in the tablet formulations.

Spectroscopy, Near-Infrared↗
PubMedDate not supplied

Determination of terbutaline sulfate in dosage forms by liquid chromatography with electrochemical detection.

A liquid chromatographic method with electrochemical detection has been developed for the determination of terbutaline sulfate in dosage forms. A cyanopropyl bonded-phase column is used with a mobile phase consisting of methanol-0.1 M monobasic potassium phosphate containing 0.1M sodium heptanesulfonate and 1mM disodium ethylenediaminetetraacetate (15 + 85). The compound of interest is detected at a glassy carbon electrode held at a potential of +0.9 V vs silver-silver chloride. The response is linear from 0 to 10 micrograms/mL terbutaline sulfate. The method is applicable to tablet composites, individual tablets, dissolution determinations, and injections. Results and supporting data are reported for the above analyses.

Chromatography, Liquid↗
PubMed1999

Tackiness of acrylic and cellulosic polymer films used in the coating of solid dosage forms.

The objective was to determine the tackiness of acrylic and cellulosic polymer films in order to make predictions on the tackiness (agglomeration) of coated dosage forms during coating and curing. Force-displacement curves of the detachment process of two polymeric films were used as a measure of tackiness. Various polymers (cellulosic (Aquacoat and acrylics (Eudragit RS 30D, L 30D, NE 30D)), plasticizers (triacetin, triethyl citrate, tributyl citrate, acetyltributyl citrate) and anti-tacking agents (talc and glyceryl monostearate) were investigated. The order of tackiness for films prepared from the different aqueous polymer dispersions was in order of Eudragit NE 30D > RS 30D > RL 30D > Aquacoat. The tackiness increased with increasing plasticizer concentration due to the softening of the polymer. A correlation between the minimum film formation temperature and the tackiness was observed, however, no correlation between the tackiness and the lipophilicity of the plasticizer was seen. Talc and glyceryl monostearate (GMS) reduced the tackiness of the films significantly, with GMS being effective at much lower concentrations. Curing of Eudragit RS 30D-coated theophylline beads at temperatures higher than 40 degrees C in an irreversible agglomeration of the beads and damage of the coating upon separation of the beads. This resulted in a faster release than with uncured beads. Blending the beads with talc just prior to the curing step eliminated the agglomeration and therefore film damage, even at a curing temperature of 60 degrees C.

Acrylates↗
PubMed1987

Dosage form and formulation effects on the bioavailability of vitamin E, riboflavin, and vitamin B-6 from multivitamin preparations.

The effects of formulation factors and pharmaceutical dosage form on the bioavailability of RRR-alpha-tocopherol (d-alpha-tocopherol), riboflavin, and pyridoxine hydrochloride were studied after administration of two capsule formulations and a tablet to 12 normal humans. Absorption of RRR-alpha-tocopherol was increased from the Aquabiosorb soft elastic gelatin (SEG) capsule formulation compared with the modified standard-SEG capsule and the commercial tablet. There were no significant differences in bioavailability of riboflavin and pyridoxine hydrochloride between the SEG formulation and the tablet albeit a trend toward consistent absorption was seen from the SEG formulation. The modified-SEG formulation exhibited significantly lower bioavailability for these water-soluble vitamins. The enhanced bioavailability of vitamin E and the trend towards faster and more consistent absorption of riboflavin and vitamin B-6 from the SEG formulation may be related to the surfactant vehicle employed and the attendant wetting properties. The results also suggest ethnic differences in vitamin bioavailability.

Adult↗
PubMed1985

Temazepam in fast dispensing dosage form as a premedication for children.

Forty-seven children aged between four and 11 years received temazepam 0.5 mg/kg in a novel fast dispensing dosage form. The preparation was well accepted and associated with few side-effects. Satisfactory sedation and anxiolysis was obtained in over 93% of patients. The relative merits of a variety of routes of administration of premedicant drugs for children are discussed and the advantages of buccally administered formulations for this age group are presented.

Administration, Oral↗
PubMed2000

[Mucoadhesive oral tablets--a modern dosage form with controlled drug release].

The review paper summarizes the principal pharmaceutical and medical information about the hitherto achieved results in the development of bioadhesive dosage form concentrating on mucoadhesive oral tablets. The site of administration of the tablets is the facial pocket. Due to specific properties of the mucous layer on the buccal mucosa and mucoadhesive polymers from which the tablets are manufactured, tablets adhere to the mucosa. The adhesion may take a certain period of time and during the whole period the active ingredient is gradually released. Absorption of the drug through the mucous membrane of the oral cavity has a number of advantages, in particular with respect to the stability of the drug. Various types of mucoadhesive tablets are being developed. The system releasing the drug only in one direction, i.e. direct to the mucosa, seems to be very advantageous. In the evaluation of mucoadhesive tablets, two parameters are of particular importance, the bioadhesive force and the rate of drug release. Oral mucoadhesive tablets can be employed in the treatment of both systemic and local diseases.

Adhesiveness↗
PubMed2004

Statistical method for evaluation of dissolution stability in the formulation development of solid dosage forms: tablets of amonafide.

A statistical method for the evaluation of the dissolution stability results and for selecting the most stable formulation within a solid dosage form development is discussed. Three types of tablets of an antineoplastic drug, amonafide, stored at a relative humidities (RH), 45% and 75%, were used. The drug release from tablets was tested before and after storage. The experimental data were statistically fitted to empirical model equations. Furthermore, the best mathematical fit was the statistical comparison of the residuals. From the selected model equation, time-dependent dissolution (Q45 and DE45) and dissolved quantity-dependent parameters (t70, t100 and MDT) were calculated. A useful parameter to present and evaluate the results obtained in comparative stability studies was defined: the Modification Factor (MF). It allowed the selection of the most stable formulation in the easiest and fastest way: the most stable formulation should present the smallest modification of the studied characteristics, in other words, the smallest MF value. In this way, tablets II (manufactured by wet granulation and with Emcompress as main excipient) showed the greater dissolution stability of the three types of tablets studied. Amonafide tablets must be packaged in impermeable containers, since the environmental relative humidity strongly modifies their dissolution characteristics.

Adenine↗
PubMedDate not supplied

Animal experiments as a model for clinical trials of a new dosage form of mitomycin C for peritoneal carcinomatosis.

Rabbits with peritoneal carcinomatosis induced by VX2 carcinoma were used as an experimental model to study a new dosage form of mitomycin C, MMC-CH, comprising activated carbon adsorbing mitomycin C. Rabbits revived an intraperitoneal injection of mitomycin C (1 mg/kg in the form of MMC-CH or 0.185 mg/kg in the form of mitomycin C solution). The two doses were equal in toxicity. MMC-CH extended survival time measured in days to 139% as compared to mitomycin C solution. Autopsy findings showed peritoneal carcinomatosis to be much less developed with MMC-CH than with mitomycin C solution. Hematological and blood biochemical analyses showed no remarkable abnormality.

Animals↗
PubMed1981

Effect of docusate sodium on drug release from a controlled-release dosage form.

This study was designed to determine the effect of a clinically used surfactant, docusate sodium, on the release of chlorpheniramine from a controlled-release dosage form (encapsulated coated pellets). In vivo treatments consisted of the controlled-release capsule alone or with 200 mg of docusate sodium. Plasma chlorpheniramine levels were determined, and the AUC was calculated. No significant difference in AUC values was observed between the two treatments. At a concentration below the CMC, docusate sodium enhanced the in vitro drug release rate. The surfactant exerted a greater effect on the release of the first one-third of the drug contained in nonwax-coated pellets. At the CMC, 0.02% (w/v), docusate sodium rapidly entrapped chlorpheniramine in micelles. The overall enhanced dissolution rate in vivo may have been offset by micellar drug entrapment.

Biological Availability↗
PubMed1989

Simultaneous determination of chlorzoxazone and acetaminophen in combined dosage forms by an absorbance ratio technique and difference spectrophotometry.

Two spectrophotometric methods have been developed for the simultaneous determination of chlorzoxazone and acetaminophen in their combined dosage forms. No preliminary separation step is required in either method. The first, an absorbance ratio technique using the isoabsorptive point as one of the wavelengths, together with "Q curve" analysis gives accurate and reproducible results for both drugs. The second, a difference spectrophotometric method is based on measurement of absorbance of an alkaline solution relative to that of an acidic solution of identical concentration of the sample at two different wavelengths. The method is suitable for routine analysis of such combinations of the drugs.

Acetaminophen↗
PubMed2000

A validated method for the determination and purity evaluation of benazepril hydrochloride in bulk and in pharmaceutical dosage forms by liquid chromatography.

A gradient liquid chromatographic (LC) method has been developed for the determination and purity evaluation of benazepril hydrochloride in bulk and pharmaceutical dosage forms. The method is simple, rapid and selective. 5-Methyl-2-nitro phenol has been used as internal standard. The method is linear in the range of 50-800 microg. The precision for inter and intra-day assay variation of benazepril hydrochloride is below 1.6% RSD. The accuracy determined as relative mean error (RME) for the intra-day assay is within +/- 2.0%. The method is stability indicating, and is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed1991

A simple and rapid method for the quantification of Eudragit RS100 and RL100 poly(methacrylates) in sustained-release dosage forms.

A colorimetric ion-pair complexation method has been developed which provides a simple and rapid way of quantifying Eudragit RS100 and RL100 in pharmaceutical dosage forms. The quaternary ammonium groupings in these polymers appear to form an ion-pair complex with the dye tropaeolin OOO. When extracted into an organic phase, the optical density at 484 nm is linearly related to polymer concentration. Control of pH is important, and it should be maintained within the range 4.5 to 9.0. A wide range of pharmaceutical excipients commonly used in tablet, pellet, and film-coating formulations did not interfere with formation of the complex, but certain drugs were found to significantly enhance or decrease the assay response. Good reproducibility, precision, and accuracy were demonstrated when the method was applied to a film-coated pellet formulation containing an interfering drug (promethazine hydrochloride). However, removal of interfering substances must be optimized. The method was sufficiently sensitive for the determination of polymer on a single dose unit of encapsulated beads.

Acrylic Resins↗
PubMed1996

[Study on the stability of Japanese encephalitis vaccine--development of freeze-dry dosage form].

In order to prolong shelf-life and improve the quality of the vaccine product, not only an effective stabilizer but also a more proper dosage form has been sought. The stability of a Japanese encephalitis (JE) vaccine produced from mouse brain along with a variety of stabilizers and lyophilization protocols was evaluated. Without any stabilizers added, almost 90% of the antigenicity would vanish after freeze-drying process. Comparative studies of various compounds, including carbohydrates, amino acids, peptides and medium 199, on both antigenicity preservation and thermostability of the vaccine were carried out. The results indicated that the best reconstituted vaccines were prepared with two stabilizer formulations, sucrose and sucrose/gelatin. They were further examined by accelerated stability test at room and higher temperatures. The sucrose-added lyophilized vaccine can retain its original antigenicity for more than 60 days both at 37 degrees C and 45 degrees C. We conclude the thermostability efficiency of each of the stabilizers tested is as that follows: sucrose > sucrose/gelatin > gelatin/medium > gelatin.

Animals↗