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PubMed2006

[The importance of micronization in the design of dosage forms II. Pharmaceutical technological considerations].

The role of particle size reduction and particle engineering is growing considering the design and manufacturing of drug carrier systems. The objective of the review is to summarize and compare the micronization methods based on particle size reduction and which are applied to improve drug dissolution and bioavailability. These methods are effective especially when suitable pharmaceutical excipients are used by cogrinding. Beside formation of engineered particles, milling remains important to design particles with the desired size, shape and surface characteristics.

Dosage Forms↗

PubMed1982

Towards a new galenic dosage form, the liposomes?

Liposomes used first as models for the study of cellular membrane permeability have been proposed about ten years ago as intracellular carriers of therapeutic substances. Since then a large number of fields of application have been explored. The difficulties encountered are important enough for having hampered any therapeutical application. Nevertheless, the first results are not negligible and provided that the efforts keep their multidisciplinary character, the concept of intracellular carrier should meet some success.

Adjuvants, Immunologic↗

PubMed1975

Column chromatographic analysis of barbiturates in their dosage forms. II. secobarbital, amobarbital, and pentobarbital.

A general method for the analysis of barbiturates, using column parition chromatography, was extended to the assay of secobarbital, amobarbital, and pentobarbital. A solution of the barbiturate constitutes the immobile phase in the chromatographic system. It is eluted with ether-isooctane (1+9) and passed onto a K3PO4 column, which retains the barbiturate while extraneous materials are washed out. The barbiturate is removed from the column with etherisooctane (3+1), extracted from the eluate with NH3, and measured spectrophotometrically.

Amobarbital↗

PubMed1980

High-performance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: separation of impurities and metabolites.

A high-performance liquid chromatographic (HPLC) system, consisting of a methanol-water (3:2 v/v) mobile phase and a Zorbax CN column with m-phenylphenol as the internal standard, was utilized to determine the purity of griseofulvin bulk drug substance, to assay griseofulvin in powders, tablets, capsules, and boluses, and to separate griseofulvin from its metabolites. The method was tested on commercial griseofulvin samples, griseofulvin tablets, and a mixture of griseofulvin and its metabolites. The HPLC method is compared to a GLC method.

Chromatography, High Pressure Liquid↗

PubMedDate not supplied

[Acute toxicity of aversectin C : various routes of administration and dosage forms].

The acute oral, cutaneous, and inhalation toxicity of aversectin C was studied on white unbred rats and mice. The compound was less toxic for rats than for mice, the LD50 for oral administration being 90 and 33 mg/kg, respectively. Aversectin C exhibited a maximum acute toxicity upon the inhalation in rats (LD50 = 40 mg/kg), while a minimum toxicity level was observed for the cutaneous application in rats (1700 mg/kg).

Administration, Inhalation↗

PubMed1992

Principle and investigation of the bioadhesion mechanism of solid dosage forms.

The development of bioadhesive tablets requires a good knowledge of their adhesion mechanism and the possibility of using an accurate in vitro evaluation technique. The bioadhesion mechanism is not basically different from the general adhesion mechanism, but it is necessary to take into account the biological nature of at least one of the two substrates involved in the process. The hydrated joint created at the molecular interface, resulting from the inter-penetration of the polymeric chains of the mucin and the bioadhesive product, is especially interesting, because its viscoelastic properties make it a damping device for the stresses transmitted to the bioadhesive surface.

Adhesiveness↗

PubMed2004

Differential electrolytic potentiometric determination of some thiol compounds in their dosage forms.

The application of direct current differential electrolytic potentiometry to an aqueous titration of L-cysteine hydrochloride, captopril and D-penicillamine has been investigated. The basic character of thiol compounds in nitric acid is enhanced to permit their direct titrations with silver nitrate. A pair of silver amalgam electrodes was used as an indicating system. Titration curve shapes obtained are almost symmetrical with sharp peaks. The optimum current density for those titrations was found to be 0.2-2 microA/cm2. The procedure was applied successfully to the determination of certain thiol compounds in drug formulations and the results were favorably compared statistically with those obtained from official methods.

Dosage Forms↗

PubMed1993

[The way for carrying medicine and its containers (XI): "dosage form of patent medicine in the Edo Period"].

In the Edo period, there was a prescribed medicine and a patent one. The former was liquid preparation to be decocted and the latter was solid one. It took a lot of time to prepare a decoction medicine and it was troublesome work. A scene where a person was preparing a decoction medicine in a tumble-down house for a patient was often described in literature of the Edo period to express that they have a serious patent by a novelist. On the other hand, a solid preparation was handy to carry it and convenient for taking so that it was accepted by customers.

Dosage Forms↗

PubMed1995

Titrimetric determination of captopril in dosage forms.

Two titrimetric methods are proposed for the determination of captopril in pure form or in tablets. In the first method iodide selective electrode is used for indirect titrimetric assay of captopril. This compound forms silver salt in presence of excess silver ions, the excess silver ions are determined potentiometrically with standardized iodide solution and an iodide selective electrode. The second method involves the titrimetric determination of captopril using a new oxidimetric titrant 2.3-dichloro-5.6-dicyano-1.4-benzoquinone (DDQ) in anhydrous acetic acid. The equivalent point is detected potentiometrically using calomel and platinum electrodes. The two methods allow semimicro-determination of captopril, the results by the proposed procedures are in good agreement with those obtained by the official method.

Benzoquinones↗

PubMed2004

Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenolol.

Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA's the assumption was made that these tablets were bioequivalent to the innovator product. The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP).

Administration, Oral↗

PubMedDate not supplied

Anticancer agents adsorbed by activated carbon particles, a new form of dosage enhancing efficacy on lymphnodal metastases.

A new dosage form consisting of small activated carbon particles which adsorb Aclacinomycin A, Adriamycin, Mitomycin C or Pepleomycin was prepared in order to deliver larger amounts of anticancer agents to the lymph nodes through the high ability of lymphatics to adsorb particles. Animal experiments showed that: The LD50 values of the new dosage form were higher than those of the dosage in solution. The concentration of agents in lymph nodes was maintained at a higher level in the new dosage form than in solution form. Clinically 33% of lymphnodal metastatic lesions became degenerative or inflammatory after a single administration.

Aclarubicin↗

PubMed2000

[Factors influencing liberation of drug from semisolid dosage forms].

Liberation of salicylic acid--as a model active agent--was investigated from white petrolatum, creams w/o and o/w types and hydrogels. Active agent was applied in suspended, dissolved forms, in inclusion complexes and solubilized state. The process of liberation was studied by a continuous through-flow method, with Hanson vertical diffusion cell. The results of experiments were evaluated by factorial design method. Increase of the concentration of salicylic acid, polarity of vehicle and solubilized state of drug increased the drug release. It was established that the partitioning released drug was the most important step of drug release. Factors changing partitioning influenced the liberation to the highest degree.

Delayed-Action Preparations↗

PubMed2000

Bioadhesive-based dosage forms: the next generation.

Prolonged contact time of a drug with a body tissue, through the use of a bioadhesive polymer, can significantly improve the performance of many drugs. These improvements range from better treatment of local pathologies to improved drug bioavailability and controlled release to enhanced patient compliance. There are abundant examples in the literature over the past 15 years of these improvements using first generation or "off-the-shelf" bioadhesive polymers. The present mini-review will remind us of the success achieved with these first-generation polymers and focus on proposals for the next-generation polymers and attendant benefits likely to occur with these improved polymeric systems.

Adhesives↗

PubMed1997

Determination of bromhexine and ambroxol in pharmaceutical dosage forms, urine and blood serum.

Data presented in this paper show that bromhexine and its pharmacologically active metabolite can easily be determined by capillary zone electrophoresis. The composition of the running buffer had a significant effect on the reproducibility of the migration time for which a carrier solution containing 30 mM phosphate buffer (pH 3.0), 5 M urea and 10% (v/v) acetonitrile was used. The method was validated with respect to its response linearity and reproducibility. The method is suitable for the determination of bromhexine and ambroxol in several samples such as pharmaceuticals, urine and serum. Photodiode-array detection permitted the rapid identification of both drugs in the sample analyzed.

Ambroxol↗

PubMed2003

Kinetic spectrophotometric determination of famotidine in commercial dosage forms.

A simple kinetic spectrophotometric method is described for the determination of famotidine. The method is based on the oxidation of the drug with alkaline potassium permanganate. The reaction is followed spectrometrically by measuring the rate of change of the absorbance at 610 nm. The initial-rate and fixed-time (at 12 min) methods are adopted for determining the drug concentration. The calibration graphs are linear in the ranges of 2-10 microg mL(-1) and 1-8 microg mL(-1) using the initial-rate and fixed-time methods, respectively. The method has been applied to the determination of famotidine in tablet formulations. The obtained results are compared statistically with those given by a reference spectrophotometric method.

Algorithms↗

PubMedDate not supplied

Validation of a liquid chromatographic method for determination of tacrolimus in pharmaceutical dosage forms.

An accurate, simple, and reproducible liquid chromatographic method was developed and validated for the determination of tacrolimus in capsules. The analysis is performed at room temperature on a reversed-phase C18 column with UV detection at 210 nm. The mobile phase is methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy, and specificity by forced decomposition of tacrolimus, using acid, base, water, hydrogen peroxide, heat, and light. The response was linear in the range of 0.09-0.24 mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91%, respectively. Recoveries ranged from 98.06 to 102.52%.

Chromatography, Liquid↗

PubMed1999

Spectrophotometric estimation of D-penicillamine in bulk and dosage forms using 2,6-dichloroquinone-4-chlorimide (DCQ).

A simple colorimetric method for the determination of D-penicillamine in pure form and pharmaceutical formulations is described. The method is based on coupling between D-penicillamine and 2,6-dichloroquinone-4-chlorimide (DCQ) in dimethylsulphoxide. The optimum conditions for the reaction were investigated and incorporated into the procedure. The reaction forms a yellow 1:1 complex with maximum absorbance at 431 nm (epsilon = 3,700). Regression analysis of Beer's plot showed good correlation (r = 0.9998) and the calibration graph was rectilinear over the range 4-20 microg/ml(-1) with a detection limit of 0.15 microg/ml(-1) . The average recovery for the commercial capsules was 101.66% with an RSD of 1.57%. The results obtained were sufficiently accurate, reproducible and in accordance with those given by the official method. The method is specific for the intact drug, and can be adopted in the presence of some interfering substances.

Buffers↗

PubMed1993

The development of oral liquid dosage forms of metronidazole.

The stability of eight samples of metronidazole in aqueous vehicles was studied using a modified HPLC assay method. The samples were prepared using either metronidazole powder (5 mg/ml), metronidazole hydrochloride injection powder (10 mg/ml), or metronidazole powdered tablets (10 mg/ml). The samples prepared using metronidazole hydrochloride powder were stable and clear for at least 133 days at 25 degrees C. Their pH values were between 1.8 and 2.0. The samples prepared from metronidazole powder had pH values close to neutral and were stable for at least 45 days at room temperature (25 degrees C). However, to keep the drug in solution, the concentration of metronidazole powder was reduced to 5 mg/ml. The powdered tablets did not yield good uniform suspensions.

Administration, Oral↗