59 results about "Dissolution testing" patented technology

[Problem] As compared with the current oral sustained-release preparation containing tamsulosin hydrochloride which have been supplied to the medical setting, there is a problem to provide a sustained-release pharmaceutical composition in which efficacy is equivalent or even better, adverse events such as adverse reactions (e.g., postural hypotension) are reduced, dose can be increased and, if desired, ingestion of food is not limited. [Means for Resolution] A sustained-release pharmaceutical composition, characterized in that, there are contained tamsulosin or a pharmaceutically acceptable salt thereof and a carrier for a sustained-release pharmaceutical composition and, when dissolution test is carried out according to Japanese Pharmacopoeia Dissolution Test Method 2, the tamsulosin release after 7 hours from the start of the dissolution is about 20 to about 85%.

Improved sampler apparatus and methods for dissolution testing include a controller that determines whether several different dissolution testing methods can be performed concurrently by the sampler and controls the sampler in response to the determination; fluid delivery apparatus adapted to pierce a septum and to deliver fluid to or from a collection receptacle through a first aperture, and to permit air flow to or from the collection receptacle through a second aperture; a syringe pump including a distributor having apertures through which fluid flows into and out of the pump chamber, the piston of the syringe pump being moveable adjacent the apertures; and/or a leak sensor responsive to the presence of spilled fluids.

A dissolution test apparatus may include a vessel support member, a sensor support member, infrared temperature sensors, and an electronic controller. The vessel support member may have apertures for receiving vessels. The infrared temperature sensors are mounted at the sensor support member. Each infrared temperature sensor is positioned proximate to a respective vessel mounting site to receive infrared radiation emitted by media contained in a vessel mounted at the vessel mounting site, and is configured to transmit a measurement signal indicative of the temperature of the media. The electronic controller communicates with the infrared temperature sensors and is configured to receive and process the measurement signals transmitted from the infrared temperature sensors. The electronic controller may be configured to control media temperature in the vessels.

Methods and systems for determining a dissolution profile of a sample material, and for solubilization screening of a library defined by an array comprising multiple sample materials are disclosed. The methods and systems are particularly advantageous for sampling and evaluation of very small samples, and can be advantageously applied in connection with evaluation of drug candidates.

The invention relates to an arginine ibuprofen tablet which is antipyretic and analgesic, and a preparation method. The arginine ibuprofen tablet contains arginine ibuprofen and auxiliary material by weight proportion: 30%-90% of arginine ibuprofen, 10%-70% of auxiliary material and 0-10% of coating material. The preparation method adopts raw material direction compression or granule preparation; the prepared tablet can be coated or not be coated. The arginine ibuprofen tablet has short response time. As indicated in dissolution test, the dissolution rate is more than 95% in 20 minutes. 20 male volunteers take two preparations of arginine ibuprofen tablets (equal to 400 mg of ibuprofen) and ibuprofen tablets (400mg) for relative bioavailability research; the peak time of arginine ibuprofen tablet is 0.5h and the peak time of ibuprofen tablet is 2.0h. The test indicates that the arginine ibuprofen tablet has quick absorption and short peak time. Besides, the arginine ibuprofen tablet overcomes the pungent taste of arginine ibuprofen syrup and granules and can be taken by patients conveniently, so as to have the advantages of convenient carrying and low cost.

Equipment and method of use for in vitro buccal dissolution testing. The invention is particularly useful for evaluating the effect of taste-masking in oral dosage forms.

The invention discloses a simple type test device for a dissolution rate of a flowing pool. The simple type test device comprises the flowing pool, a filter, a multichannel peristaltic pump, a heating pool, a solvent storage bottle and a controller, wherein an upper opening of the flowing pool is in sealing connection with one opening of the filter; the other opening of the filter is communicated with the solvent storage bottle through a hose a; a lower opening of the flowing pool is connected with one end of a hose b; the other end of the hose b is connected with an outlet of the multichannel peristaltic pump; an inlet of the multichannel peristaltic pump is communicated with the solvent storage bottle through a hose c; the flowing pool is arranged in the heating pool. The simple type test device can work in an open or closed form; the heating temperature and the solvent flow rate are controlled; the simple type test device has the characteristics of simple structure, convenience in operation, low cost, and the like and is fit for determining the releasing rate of various drug sustained-release preparations, such as drug release brackets, implants, microspheres, microchips, lipidosome, of institutions of colleges, research institutions, pharmaceutical factory, and the like.

Apparatus and method for dissolution testing of active substances in various dosage forms is provided. The apparatus has filtration cells equipped and configured to simulate bodily functions, operate continuously and facilitate testing various types of dosage forms including, but not limited to, tablets, capsules and those having non-disintegrating substrates.

The pharmaceutical preparation for oral contraception has 28 daily dosage units, of which at least 21 daily dosage units each contain from 1.5 mg to 2 mg of dienogest and from 0.015 mg to 0.02 mg of ethinyl estradiol together in a pharmaceutically acceptable carrier. Seven or fewer daily dosage units contain no effective ingredient. Each daily dosage unit can be a film tablet for oral administration, which has a tablet core and film coating on the tablet core. At least 30% of the dienogest is released from the tablet core preferably in a delayed manner after more than 30 minutes, while at least 70% of the dienogest and ethinyl estradiol are released from the film coating preferably in 30 minutes, as determined by a standard dissolution test.

The invention discloses a coal gangue leaching and immersion testing device under a multi-field coupling effect. The coal gangue leaching and immersion testing device comprises an inner barrel, an outer barrel, a leaching solution barrel and a leaching solution collector, wherein the inner barrel is divided into a leaching solution collection region and a leaching region for filling a testing material through filtering and penetration plates; a liquid inlet plate capable of bearing pre-set pressure is arranged above the leaching region and a liquid inlet hole is formed in the liquid inlet plate; the leaching solution collection region is connected with the leaching solution collector; the leaching solution barrel is connected with the liquid inlet hole of the liquid inlet plate through a pipeline; quantitative saline water is filled into the outer barrel; the inner barrel is arranged in the outer barrel; a semiconductor chilling plate is arranged in the outer barrel. The testing devicedisclosed by the invention has the advantages of simple structure, reasonable structure and convenience for utilization; the testing device can be used for simulating a leaching and immersion test ofgoaf solid filler under the multi-field coupling effect of a stress field, a seepage field, a temperature field, an acid-alkali field and the like; a collected leaching solution is used for carryingout a heavy-metal element dissolution testing experiment, and basic data information is provided for solving the environment protection problem of solid filling in a coal mine goaf.

Taught herein is a solid, oral, controlled-release pharmaceutical composition of tamsulosin hydrochloride in the form of an enteric-coated tablet, wherein tamsulosin hydrochloride is homogenously dispersed within a matrix consisting of a mixture of a fatty component and a hydrophilic component, together with at least one diluent, and optionally other pharmaceutically acceptable excipients, exhibiting the following dissolution profile of tamsulosin hydrochloride, as measured in a Type II paddle apparatus in accordance with the dissolution testing method specified in the European Pharmacopoeia, i.e., at 37±0.5° C. and 100 rpm in a 0.1 N HCl buffer for 2 hours, followed by pH 7.2 buffer for the rest of the test: 10-40% dissolution during first 2 hours (in HCl), 35-70% dissolution after 3 h (in pH 7.2 buffer system), not less than 70% dissolution of the declared content after 5 h (in pH 7.2 buffer system).

A dissolution test vessel configured for direct vessel heating includes a lateral wall, a resistive heating element, and a temperature-sensing element. The resistive heating element and the temperature-sensing element are bonded directly to the lateral wall, and may be formed by dispensing flowable materials onto the lateral wall. The resistive heating element includes a contiguous first heating element end, heating element section, and second heating element end. The temperature-sensing element includes a contiguous first sensing element end, sensing element section, and second sensing element end. The vessel may communicate with a heater control system, which may be provided with a dissolution test apparatus at which the vessel is mounted.

The invention provides a composition for oral pharmaceuticals, using 5'-Ara-C-O-amino ester or its salt as an active ingredient. According to dissolution testing, a second method in the appendix XC of the second part of Chinese pharmacopoeia edition 2010, the dissolution of the active ingredient of the composition is higher than or equal to 80% in 15 min, by using 900 ml of water as a dissolving medium at a rotation speed of 50 rpm. Organic acids are added into a prescription of the composition, a certain ratio of the organic acids is maintained, and thus the stability of pharmaceutical composition is substantially improved. A short-term stability test presents no increase in impurity.

In acquiring and managing measurement data relating to operating parameters of a dissolution tester, operating parameters are measured by operating one or more sensors. The measured operating parameters are transmitted from the sensors to a user computing device. It is then determined whether the measured operating parameters are in compliance or non-compliance with one or more standards, by comparing the measured operating parameters with a plurality of corresponding predefined values. The measured operating parameters and indications of compliance or non-compliance of each measured operating parameter are stored as a data record in a memory local or remote to the user computing device. The data record may be accessible by a computing device remote from the memory. The operating parameters may include, for example, shaft parameters.