126 results about "Bioequivalence" patented technology

There is provided a method for preparing an orally disintegrating tablet (ODT) composition comprising microparticles of one or more taste-masked active pharmaceutical ingredient(s), rapidly-dispersing microgranules, and other optional, pharmaceutically acceptable excipients wherein the ODT disintegrates on contact with saliva in the buccal cavity in about 60 seconds forming a smooth, easy-to-swallow suspension. Furthermore, the microparticles (crystals, granules, beads or pellets containing the active) applied with a taste-masking membrane comprising a combination of water-insoluble and gastrosoluble polymers release not less than about 60% of the dose is in the stomach in about 30 minutes, thus maximizing the probability of achieving bioequivalence to the reference IR product having rapid onset of action (short T_max). A process for preparing such compositions for oral administration using conventional fluid-bed equipment and rotary tablet press is also disclosed.

A method of treating or preventing myocardial ischemia in a patient in need thereof comprising administration of a controlled-release Galenical preparation of pharmaceutically acceptable Diltiazem including the pharmaceutically acceptable salts thereof, suitable for evening dosing every 24 hours containing from about 180 mg to about 420 mg of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a C_max of Diltiazem in the blood at between about 10 hours and about 17 hours after administration, the preparation comprising the form of Diltiazem in oral sustained-release dosage form in which the Diltiazem is adapted to be released after administration over a prolonged period of time and exhibits when given to humans

(i) a higher bioavailability when given at night compared to when given in the morning without food according to FDA guidelines or criteria and

(ii) bioequivalence when given in the morning with and without food according to the same FDA guidelines or criteria.

The invention relates to the formulation and quality control of liquid drug suspensions. In particular, the invention relates to methods of formulating liquid suspensions comprising drug-containing resin particles. The invention also relates to methods of confirming the acceptability of drug-containing resin particles for use in formulating liquid drug suspensions. The invention further relates to methods of formulating liquid suspensions in which drug-containing resin particles, the liquid suspension, or both are modified to achieve a desired in vitro dissolution profile. The invention also relates to a novel dissolution method and methods of predicting in vivo bioequivalence based on in vitro dissolution methods.

A rapid method for assessing the bioequivalence of iron in iron-supplement formulations, particularly iron-sucrose formulations is described, which is based upon the kinetics of reduction of iron (III) to iron (II) in a sample of the formulation. Quality control methods and associated kits also are described.

Embodiments relating to methods, processes and systems for measuring progesterone are provided. In particular, methods permit measurement and quantification of synthetic and/or endogenous progesterone from a progesterone-containing blood fluid sample by measuring a progesterone carbon isotope ratio by mass spectrometry and calculating the fraction of synthetic progesterone in the sample from the isotope ratio. Also provided are methods of evaluating bioequivalence of a synthetic progesterone composition using any of the methods provided herein. In an embodiment, methods of precise measurements of plasma levels are described for detection of progesterone analytes such as total progesterone, endogenous animal progesterone, and synthetic progesterone. Correcting for fluctuations in endogenous progesterone levels following application of synthetic progesterone allows a significant reduction in the number of test subjects required to evaluate bioequivalence of a synthetic progesterone composition.

The invention relates to a flupentixol and melitracen medicinal composition and a preparation thereof, and belongs to the technical field of pharmaceutical preparations. The flupentixol and melitracenmedicinal composition is prepared from flupentixol dihydrochloride, melitracen hydrochloride and an antioxidant. The flupentixol and melitracen medicinal composition disclosed by the invention has the advantages that by adding the antioxidant, the stability of a flupentixol and melitracen compound preparation can be effectively enhanced, and impurities such as Lu28-159 and trifluoromethyl thioxanthone produced by degrading flupentixol can be effectively controlled, so that impurity level is reduced and the safety and the effectiveness of a product are ensured; flupentixol and melitracen medicinal tablets prepared by the preparation method disclosed by the invention have similar in-vitro dissolution behavior and bioequivalence with original research tablets Deanxit.

The invention provides a space radiation effect bioequivalence evaluation method of aliphatic polymer insulation materials for space navigation, and relates to a bioequivalence evaluation method of the displacement radiation effect of different radiation sources of aliphatic polymer insulation materials for particle radiation environment. The problem of great evaluation error of the existing aliphatic polymer space radiation effect evaluation method for space navigation is solved. The LET value, the ionospheric absorption dosage and the ejection range of each radiation source in a sample of a material to be tested can be calculated; according to the ejection range of each radiation source in the sample of the material to be tested, the thickness of the sample of the material to be tested is determined, so that each radiation source performs radiation test correspondingly to one tested material, so that the radiation particles of each radiation source completely penetrate through the thickness of the corresponding sample of the material to be tested; after the radiation, a relationship curve of each physical quantity and the ionospheric absorption agent quantity obtained through microcosmic structure analysis of each radiation source under the radiation condition, and a relationship curve of each physical quantity and the ionospheric absorption agent quantity obtained through performance test are made. The method is used for evaluating the aliphatic polymer insulation materials.

The invention discloses a nifedipine sustained release tablet and a preparation method thereof. The grain diameter D90 of nifedipine is 5-10 mu m, and a tablet core is prepared from, in percentage byweight, 25% of nifedipine, 5%-10% of retardant composition, 0.5%-1.5% of tween 80 and the balance of other auxiliary materials. In order to guarantee the storage quality of the tablet core, the tabletis colored and coated, and the weight gain of a coat is 4%-5%. Initiative formula composition is adopted, a sustained release mode is innovated, and the nifedipine sustained release tablet capable ofcontinuously releasing a drug within 12 h is prepared, two times of human body pre-BE (bioequivalence) (12 cases, empty stomach/full stomach) research prove the BE of the product, and besides, a dissolution method related in vitro and in vivo is developed. The drug release principle and process monopoly of the nifedipine sustained release tablet are broken through, the adopted formula and preparation process are simpler and more controllable, facilitate industrial production in China and provide more clinic choices for patients and doctors, and the medication burden of the patients is reduced.

The present invention is directed to oral solid dosage forms. The solid dosage forms are sugar-free, and comprise a pharmaceutical agent and a suitable pharmaceutically acceptable excipient. Preferably, the solid dosage forms of the present invention are bioequivalent to a sugar-containing solid dosage form. Bioequivalence is preferably obtained by incorporating an ionizing agent, more preferably in the form of a buffer system, into the solid dosage forms, in an amount sufficient to maintain a portion of the pharmaceutical agent, upon dissolution of said composition in saliva, in an ionized state.

The invention discloses a quantitative analysis method for tadalafil in human blood plasma. The quantitative analysis method comprises: (1) preparation of a standard working solution; (2) sample treatment; (3) production of a standard curve; and (4) quantitative analysis, wherein a test sample is treated according to the step (3), and calculating is performed according to the standard curve equation obtained in the step (3) to obtain the concentration of tadalafil in the test sample. According to the present invention, the concentration of tadalafil in the human blood plasma is determined by using the liquid chromatography-mass spectrometry (HPLC-MS/MS) technology, such that the concentration of tadalafil in the human blood plasma is accurately quantitated; the chromatographic column, thedissolving liquid, the mobile phase, the mass spectrometry conditions and the like are reasonably selected, and the flow rate, the elution mode, the mass spectrometry conditions and other process conditions are optimized, such that the advantages of simple operation, high repeatability, good accuracy and high operability can be achieved; and the method can be directly used for the sample detectionanalysis in bioequivalence.

A rapid method for assessing the bioequivalence of iron in iron-supplement formulations, particularly iron-sucrose formulations is described, which is based upon the kinetics of reduction of iron (III) to iron (II) in a sample of the formulation. Quality control methods and associated kits also are described.

The invention belongs to the field of medicine industry and particularly relates to a method for preparing isosorbide mononitrate sustained-release capsules. The method for preparing the isosorbide mononitrate sustained-release capsules, provided by the invention, comprises the steps: (1) preparing isosorbide mononitrate quick-release micropellets; (2) preparing isosorbide mononitrate sustained-release micropellets; (3) carrying out mixing: mixing the isosorbide mononitrate quick-release micropellets with the isosorbide mononitrate sustained-release micropellets, and carrying out encapsulation, thereby obtaining the product. Shown by experimental determination, the product prepared by the technical scheme provided by the invention is good in stability, the problem, i.e., crystallization of isosorbide mononitrate is solved, and the problems of the existing processes that principal drugs and adjuvants are prone to caking and heated softening, the removal of residual solvent is not facilitated, and the micropellets are adhered are also avoided. Shown by in-vitro dissolution and in-vivo biological equivalent experimental investigations, the isosorbide mononitrate sustained-release capsules provided by the invention have bioequivalence compared with original triturates.

The invention belongs to the field of sustained-release drug preparations, and particularly relates to a trimetazidine hydrochloride sustained release tablet taking glyceryl behenate as a framework material and a preparation method of the trimetazidine hydrochloride sustained release tablet. According to the main technical scheme disclosed by the invention, a sustained-release preparation is prepared from trimetazidine hydrochloride as an effective component, only glyceryl behenate as a sustained-release framework material and auxiliary materials such as a small amount of release speed regulator. According to the trimetazidine hydrochloride sustained release tablet provided by the invention, an in vitro release rate experiment shows that the drug release is not affected by the pH environment, compared with commercially available 'vasorel' (trimetazidine dihydrochloride tablet), the trimetazidine hydrochloride sustained release tablet has good similarity (f2 is greater than 65); and the Beagle pharmacokinetic experiment in dogs shows that the trimetazidine hydrochloride sustained release tablet has bioequivalence in comparison with 'vasorel'. One trimetazidine hydrochloride sustained release tablet provided by the invention is taken twice a day, and the trimetazidine hydrochloride sustained release tablet is convenient to take, has good medicine compliance in patients, and is capable of keeping steady state plasma concentration for a long period of time. The preparation method disclosed by the invention is simple and stable in process, and is easily put into volume production.

The invention belongs to the field of biological analysis and particularly relates to a method for detecting quetiapine in human plasma by HPLCMS-MS combination. The method comprises steps of (1), human plasma sample pretreatment; (2), liquid chromatography-mass spectrum combined detection, mobile phase A and mobile phase B are utilized as a mixed mobile phase for gradient elution, the mobile phase A is acetonitrile-water, the mobile phase B is ammonium acetate-water; and (3), determination of the concentration of the quetiapine in the human plasma. The method is advantaged in that deuteratedfumaric acid quetiapine is used as an internal marker, gradient elution is performed through utilizing an InertSustain C18 column, the deuterated internal marker and a determinand have the same retention time, chemical properties and matrix effects, and reproducibility and accuracy of concentration detection of the deuterated fumaric acid quetiapine in plasma are good. The method is used for evaluating bioequivalence of each quetiapine dosage form.

The invention relates to a concentration determining method of arecoline hydrobromide in animal blood plasma. The method applies high performance liquid chromatography-tandem mass spectrum technology for concentration determination of the arecoline hydrobromide in the animal blood plasma. Beta-pinene is adopted as an internal standard substance, and the concentration of the arecoline hydrobromide in the animal blood plasma can be accurately determined. The high performance liquid chromatography-tandem mass spectrum process which is rapid, accurate and sensitive is adopted for the concentration determination of the arecoline hydrobromide in the animal blood plasma. The method is high in specificity and good in separation effect. Linearity, stability, reproducibility, and recovery tests of the method satisfy good technical requirements. The method lays methodology foundations for research of pharmacokinetics and bioequivalence of the medicine inside animals.

A transdermal formulation and method of treatment includes providing an active pharmaceutical ingredient, a poly-isobutylene or silicone PSA, optionally, an oil, a crosslinked polyvinylpyrrolidone, and optionally, silicon dioxide, wherein said formulation is prepared on a backing in a three layer transdermal delivery system formulated to provide transdermal delivery and therapeutic levels for up to seven days and optionally with an overlay system required to show bioequivalence.

The invention provides a solid dispersion method of celecoxib and a preparation method of celecoxib capsules, and the solid dispersion method comprises the following steps: mixing the celecoxib with pharmaceutical adjuvants to obtain raw and auxiliary material mixed powder, and carrying out ultramicro jet milling and/or mechanical milling on the raw and auxiliary material mixed powder, wherein thepharmaceutical adjuvants at least comprise lactose monohydrate and lauryl sodium sulfate. The solid dispersion method disclosed by the invention not only overcomes the characteristic of poor preparation of a celecoxib preparation, but also solves the problem of slow dissolution of the celecoxib, and the preparation is good in stability, so that the preparation is consistent with an original developed preparation (Celebrex) in prescription and dissolution, and the quality consistency and bioequivalence of the celecoxib preparation and the original developed preparation (Celebrex) are ensured.

The invention relates to an oxcarbazepine sustained release tablet and a preparation method thereof. According to the method adopted by the invention, raw materials are specially treated together with an auxiliary material first to prepare oxcarbazepine composition, and the particle size of the oxcarbazepine composition is strictly controlled. KG-802 is added into an extra auxiliary material. According to the oxcarbazepine sustained release tablet prepared with the method provided by the invention, the use of a large amount of a cosolvent namely sodium lauryl sulfate in an original developed preparation is avoided, the toxicity of a preparation finished product to a human body after taking is reduced, and the pollution to the environment in a preparation process is reduced; and compared with a reference product on sale, release curves in release media with different pH values can keep similar, the bioequivalence of an in-vitro test is ensured, and the release curves of the release media with different pH values are more similar to one another in comparison with the preparation on sale. The oxcarbazepine sustained release tablet provided by the invention is prepared by adopting a conventional granulation and tabletting process, the process is simple, and the oxcarbazepine sustained release tablet is suitable for large-scale production.

The invention relates to a quantitative analysis method for twelve components of Huang Qi Jian Zhong pills in rat plasma, and belongs to the field of biological analysis. A rat plasma sample is treated by protein precipitation, and the contents of twelve components of Huang Qi Jian Zhong pills in rat plasma is detected in a UPLC-MS/MS (ultra-high performance liquid chromatography-mass spectrometry) method by taking kaempferol as the internal standard. The detection method of the invention is high in sensitivity, specificity and stability, the recovery rate reaches 108.74%, the requirement forthe recovery rate can be met, and the detection efficiency can be improved. Besides, the detection method is high in reproducibility and short in analysis time, can meet the requirement for detectingthe concentration of the Huang Qi Jian Zhong pills in the rat plasma, and can be used for pharmacokinetic research and bioequivalence research of the Huang Qi Jian Zhong pills.