31 results about "Tramadol hcl" patented technology

The present invention relates to co-crystals of tramadol and co-crystal formers selected from NSAIDs, processes for preparation of the same and their uses as medicaments or in pharmaceutical formulations, more particularly for the treatment of pain. In a preferred embodiment, the co-crystal is a co-crystal of (-) -tramadol and (S) -naproxen (1:2); (+) -tramadol and (R) -naproxen (1:2) or (rac) -tramadol-Hcl-celecoxib (1:1).

The invention provides a novel preparation using tramadol hydrochloride and paracetamol compositions as the main medicaments, i.e. aminophen tramadol chewing tablet. The weight ratio of tramadol hydrochloride and paracetamol is 0.1:1-0.2:1, and the adjuvant employs medicinal excipient, which includes 50.1-83.7% of water-soluble bulking agent, crumbling agent, lubricating agent, flavoring agent, moistening agent or binding agent.

The invention discloses a pharmaceutical composition for relieving or eliminating protracted opioid abstinence syndrome and application of the pharmaceutical composition. The pharmaceutical composition comprises clonidine hydrochloride and tramadol hydrochloride in a mass ratio of (0.01-0.8):(40-60), and the application of the pharmaceutical composition in preparation of drugs for relieving or eliminating the protracted opioid abstinence syndrome is also disclosed. The pharmaceutical composition is more suitable for detoxification of opioid abuse patients, has the advantages of good effect, short time, completion in 3-5 days, safety, effectiveness and convenience in operation, has obvious clinical advantages and curative effects, can improve the medication compliance and medication experience of the patients, and prevents abuse.

The present invention relates to a pharmaceutical composition comprising the synergistic combination of a non-steroidal anti-inflammatory drug (NSAID), such as the active ingredient s-ketorolac tromethamine, and an opioid agent, such as the active ingredient tramadol chlorhydrate, which ingredients are formulated with pharmaceutically acceptable excipients. The composition is used for the control and treatment of mild and/or moderate and/or severe pain.

The invention discloses a preparation method of a coated tablet containing acetaminophen and tramadol hydrochloride. The preparation method comprises the following steps that S1, active component, a filling agent and a disintegrating agent are mixed to obtain premixed powder; the active components are the acetaminophen and the tramadol hydrochloride, and the mass ratio of the acetaminophen to the tramadol hydrochloride is 325: 37.5; S2, in the stirring process, an adhesive is added into the premixed powder, and wet particles are obtained through granulation; the adhesive is hydroxypropyl cellulose EF or hydroxypropyl methylcellulose E5; S3, the wet particles are dried and then subjected to size stabilization, then a lubricating agent is added for mixing, and total mixed particles are obtained; S4, the total mixed particles are tabletted to obtain tablets; and S5, the tablets are coated to obtain the tablet. According to the preparation method, the granulation process is simple and convenient to operate, the problems of poor compressibility, tablet cracking and the like of the acetaminophen are solved, the acetaminophen and the tramadol hydrochloride have high similarity, the preparation process is stable, the large-scale production is convenient, and the good bioavailability and the good quality safety are provided.

A method of treating pain, e.g., acute post-operative pain, by administering to a human patient(s) a therapeutically effective dose of tramadol intravenously in a dosing regimen which includes one or more loading doses administered at shortened intervals as compared to dosing at steady-state is disclosed. In certain embodiments, the dose of tramadol is from about 45 mg to about 80 mg and the second (and optionally) third doses are intravenously administered at intervals of from about 2 to about 3 hours, and thereafter the tramadol is intravenously administered at a dosing interval of about 4 to about 6 hours, until the patient no longer requires treatment with tramadol. In preferred embodiments, the intravenous dosing regimen provides a Cmax and AUC of tramadol is similar to the Cmax and AUC of an oral dose of 100 mg tramadol HCl given every 6 hours. In certain preferred embodiments, the dosing regimen comprises 50 mg IV tramadol at Hour 0, followed by 50 mg at Hour 2, 50 mg at hour 4, and 50 mg every 4 hours thereafter (e.g., until the patient no longer requires treatment with tramadol).

The invention provides a preparation method of a tramadol hydrochloride sustained-release preparation. The preparation method comprises the following steps: dissolving tramadol hydrochloride in 95% ethanol to obtain a solution A, and adding hydroxypropyl beta-cyclodextrin and mannitol into the solution A to obtain a solution B; dissolving polylactic acid and polyethylene glycol 200 in acetone to obtain a solution C, mixing the solution B with the solution C to obtain a solution D, transferring the solution D to a magnetic stirrer, continuously stirring the solution D for 12 hours, lowering thetemperature of the solution D to 0-1 DEG C within 2 hours, allowing to stand still for 12 hours, and maintaining the temperature of the solution D at 0-1 DEG C during the standing period; heating thesolution D after standing till for 12 hours, continuously stirring when the temperature of the solution D is raised to 15-18 DEG C, controlling the temperature of the solution D at 15-18 DEG C when stirring, and preparing the tramadol hydrochloride sustained-release preparation with a low-temperature spray drying method after continuously stirring for 12 hours. According to the invention, the dosage of a capsule wall material is moderate, the drying temperature of materials is low, and the prepared drug-loading preparation is uniform in size and stable in drug release, and has the characteristic of slow release.

A method of treating pain, e.g., acute post-operative pain, by administering to a human patient(s) a therapeutically effective dose of tramadol intravenously in a dosing regimen which includes one or more loading doses administered at shortened intervals as compared to dosing at steady-state is disclosed. In certain embodiments, the dose of tramadol is from about 45 mg to about 80 mg and the second (and optionally) third doses are intravenously administered at intervals of from about 2 to about 3 hours, and thereafter the tramadol is intravenously administered at a dosing interval of about 4 to about 6 hours, until the patient no longer requires treatment with tramadol. In preferred embodiments, the intravenous dosing regimen provides a Cmax and AUC of tramadol is similar to the Cmax and AUC of an oral dose of 100 mg tramadol HCl given every 6 hours. In certain preferred embodiments, the dosing regimen comprises 50 mg IV tramadol at Hour 0, followed by 50 mg at Hour 2, 50 mg at hour 4, and 50 mg every 4 hours thereafter (e.g., until the patient no longer requires treatment with tramadol).

The present invention relates to the combination of ibuprofen in the form of a pharmaceutically acceptable salt, and tramadol, or a pharmaceutical acceptable salt thereof, for use in the treatment of pain in humans, wherein the dosage of ibuprofen in the combination is comprised between 350 mg and 450 mg and the dosage of tramadol is comprised between 35 mg and 40 mg, expressed as equivalent weight of tramadol hydrochloride. The combination is suitable for the treatment of moderate to severe pain, of chronic or acute origin, and is particularly effective for those patients suffering from more intense pain. It also relates to a pharmaceutical composition comprising said fixed-dose combination of ibuprofen and tramadol.

The invention discloses a preparation method of tramadol hydrochloride sodium chloride injection, and the method comprises the following steps: weighing tramadol hydrochloride, sodium chloride and activated carbon according to the preparation amount and the amount after drying and purification, adding a proper amount of water for injection into a concentrated preparation tank, adding the weighed sodium chloride, performing stirring until the sodium chloride is uniformly dissolved, adjusting the pH value of the solution in the concentrated preparation tank to 4.5-5.5 by using 10% diluted hydrochloric acid, adding weighed activated carbon into the concentrated preparation tank, performing heating to boil to 95 DEG C or above, standing and adsorbing for 10-20 minutes, circularly performing filtering and decarbonizing into a diluted preparation tank, finally adding weighed tramadol hydrochloride into the diluted preparation tank, fixing the volume, and performing stirring until the tramadol hydrochloride is completely dissolved; and circularly performing filtering to obtain the product tramadol hydrochloride sodium chloride injection. According to the tramadol hydrochloride sodium chloride injection produced by the process, the content of related substances is obviously reduced and can be as low as 0.1% or below, and the content of the related substances is basically kept unchangedin each stage of acceleration test in the later period.

The invention provides an HPLC detection method for the tramadol hydrochloride impurity E. According to the invention, the impurity E in tramadol hydrochloride is detected through a liquid chromatography method, so the existence of the impurity E can be qualitatively analyzed, and the accurate content of the impurity E can be quantitatively analyzed. Compared with the existing TLC thin-layer chromatography method, the method is simpler and more convenient in experiment operation; chromatographic peaks are free of interference and high in sensitivity, and methodological verification results meet requirements; therefore, the detection method is good in specificity, high in sensitivity, accurate in quantification and less affected by the detection environment; the liquid chromatography detection method provided by the invention is more suitable for large-scale production and product quality control in a quality control process.