Bulk Ibuprofen Research Articles

Development and Validation of a HPLC Method for the Estimation of Tizanidine and Ibuprofen in Bulk and Dosage forms

A new method was established for estimation of Tizanidine and Ibuprofen by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Tizanidine and Ibuprofen by using Intersil ODS C18 column (250×4.6mm) 5.0µm, flow rate was 1.0ml/min, mobile phase ratio was (40:60 v/v) Potassium di hydrogen Phosphate Buffer: Acetonitrile pH 3.2 (pH was adjusted with Ortho-phosphoric acid), detection wavelength was 269nm. The instrument used was Shimadzu HPLC, UV detector 2450, Spinchrom -software version-2. The method shows linearity between the concentration range of 0.6-1.4µg/ml for Tizanidine and 120-280 for Ibuprofen. The % recovery of Tizanidine and Ibuprofen were found to be in the range of 98.0% - 102.0%. As there was no interference due to mobile phase, the method was found to be specific. The method was robust as observed from insignificant variation in the results of analysis by changes in Flow rate and wavelength variation separately and analysis being performed by different analysts.

Development of a Rapid Chemometric Reverse Phase HPLC Method for the Simultaneous Estimation of Paracetamol and Ibuprofen in Bulk and Tablet Formulation

Development of a Rapid Chemometric Reverse Phase HPLC Method for the Simultaneous Estimation of Paracetamol and Ibuprofen in Bulk and Tablet Formulation

Ibuprofen shortage causes headache for analgesic makers 

BASF says it has completed inspection of repairs to its Bishop, Texas, bulk ibuprofen plant, which was shut down in June due to a technical malfunction, and that it expects to initiate start-up by the end of the year. In the meantime, though, makers of headache remedies are hard pressed to find the analgesic ingredient. BASF had just completed an expansion of the plant when it had to shut down operations. The firm announced the project last year in conjunction with plans to build a new plant at its headquarters in Ludwigshafen, Germany. The combined $230 million investment was a response to growth in demand and “supply gaps in the market” for ibuprofen, BASF said at the time. The gaps turned into what some call a severe shortage following the shutdown in Bishop this summer. “This created a big shortage in the market,” says Robert Kahen, president of Dastech International,

Implementation of design of experiments approach for the micronization of a drug with a high brittle–ductile transition particle diameter

Objective: To optimize air-jet milling conditions of ibuprofen (IBU) using design of experiment (DoE) method, and to test the generalizability of the optimized conditions for the processing of another non-steroidal anti-inflammatory drug (NSAID).Methods: Bulk IBU was micronized using an Aljet mill according to a circumscribed central composite (CCC) design with grinding and pushing nozzle pressures (GrindP, PushP) varying from 20 to 110 psi. Output variables included yield and particle diameters at the 50th and 90th percentile (D50, D90). Following data analysis, the optimized conditions were identified and tested to produce IBU particles with a minimum size and an acceptable yield. Finally, indomethacin (IND) was milled using the optimized conditions as well as the control.Results: CCC design included eight successful runs for milling IBU from the ten total runs due to powder “blowback” from the feed hopper. DoE analysis allowed the optimization of the GrindP and PushP at 75 and 65 psi. In subsequent validation experiments using the optimized conditions, the experimental D50 and D90 values (1.9 and 3.6 μm) corresponded closely with the DoE modeling predicted values. Additionally, the optimized conditions were superior over the control conditions for the micronization of IND where smaller D50 and D90 values (1.2 and 2.7 μm vs. 1.8 and 4.4 μm) were produced.Conclusion: The optimization of a single-step air-jet milling of IBU using the DoE approach elucidated the optimal milling conditions, which were used to micronize IND using the optimized milling conditions.

Effects of Polymeric Additives on the Crystallization and Release Behavior of Amorphous Ibuprofen

Some polymeric additives were studied to understand their effects on the amorphous phase of ibuprofen (IBU), used as a poorly water soluble pharmaceutical model compound. The amorphous IBU in bulk, as well as in nanopores (diameter ~24 nm) of anodic aluminum oxide, was examined with the addition of poly(acrylic acid), poly(N‐vinyl pyrrolidone), or poly(4‐vinylphenol). Results of bulk crystallization showed that they were effective in limiting the crystal growth, while the nucleation of the crystalline phase in contact with water was nearly instantaneous in all cases. Poly(N‐vinyl pyrrolidone), the most effective additive, was in specific interaction with IBU, as revealed by IR spectroscopy. The addition of the polymers was combined with the nanoscopic confinement to further stabilize the amorphous phase. Still, the IBU with addition of polymeric additives showed sustained release behavior. The current study suggested that the inhibition of the crystal nucleation was probably the most important factor to stabilize the amorphous phase and fully harness its high solubility.

Effect of particle properties on the flowability of ibuprofen powders

Powder flowability is one of the key parameters in the pharmaceutical tabletting process. The flowability is affected by both the particles’ properties and the tabletting equipment characteristics. Although it is generally accepted that powder flowability increases with an increase in particle size, quantitative studies and comprehensive theoretical insights into the particle property effects are still lacking. In this paper, ibuprofen, a non-steroidal drug widely used as an anti-inflammatory analgesic was chosen as a model material to assess the effect of particle properties on its flowability. Ibuprofen typically has a needle shaped morphology. The flowability of ibuprofen size fractions was studied in detail using two flow measurement methods. The separated fractions were also compared to magnesium stearate lubricated ibuprofen and its size fractions. The experimental results showed that powder flowability is significantly affected by both the particle size and size distribution. The finest size fraction that is separated from the bulk ibuprofen powder flows better than the bulk powder. For powders with narrow size distributions, the flowability increases significantly with the increase in particle size. In addition, admixing magnesium stearate to ibuprofen not only increases the flow function of the powder, but also reduces the internal friction angle. A theoretical analysis based on the limiting tensile strength of the powder bed was carried out and the flow conditions for particles of different size and shape were developed.

The molecular dynamics and melting transition of the confined ibuprofen in titania nanotube studied by NMR

13C NMR is employed to study the correlation between molecular dynamics and melting transition for the bulk ibuprofen and the confined ibuprofen in titania nanotubes. Under confinement, for all methyl-groups rotation remains unchanged and aromatic-ring flipping is slightly accelerated. The bulk ibuprofen melts at 351 K activating rapid molecular reorientation and rapid rotation of isobutyl-group while the confined ibuprofen completely becomes ‘liquid-like’ at 339 K activating also rapid rotation of isobutyl-group and restricted molecular reorientation. It suggests that confinement substantially changes the segmental dynamics which participates in melting transition but only slightly affects the others.

Evaluation of Mesoporous TCPSi, MCM-41, SBA-15, and TUD-1 Materials as API Carriers for Oral Drug Delivery

The feasibility of four mesoporous materials composed of biocompatible Si (TCPSi) or SiO2 (MCM-41, SBA-15, and TUD-1) were evaluated for oral drug delivery applications. The main focus was to study the effect of the materials different pore systems (unidirectional/2D/3D) and their pore diameters, pore size distributions, pore volumes on the maximal drug load capacity, and release profiles of a loaded active pharmaceutical ingredient. Ibuprofen was used as the model drug. The total pore volume of the mesoporous solid was the main factor limiting the maximum drug load capacity, with SBA-15 reaching a very high drug load of 1:1 in weight due to its high pore volume. Dissolution experiments were performed in HBSS buffers of pH 5.5, 6.8, and 7.4 to mimic the conditions in the small intestine. At pH 5.5 the dissolution rate of ibuprofen released from the mesoporous carriers was significantly faster compared with the standard bulk ibuprofen (86–63% versus 25% released at 45 min), with the fastest release observed from the 3D pore network of TUD-1 carrier. The utilization of mesoporous carriers diminished the pH dependency of ibuprofen dissolution (pKa = 4.42), providing an interesting prospect for the formulation of poorly soluble drug compounds.

Ethyl hurt by ibuprofen imports from India

Ibuprofen may offer relief from millions of headaches, but Ethyl Corp. is hoping that proposed trade legislation will solve a headache that the company has with ibuprofren imports from India. Sen. Max S. Baucus (D.-Mont.) introduced the legislation—the Trade Agreements Compliance Act of 1990 (S. 2742). Basically, it would require the Administation, if requested by Congress or the private sector, to review how well a country is complying with a trade agreement signed with the U.S. and to report the findings to Congress. When the bill first was introduced, it was aimed primarily at Japan. But it would apply to other countries as well. That suits Ethyl just fine, because the company believes that India's failure to live up to a 1981 U.S.-India bilateral subsidy agreement is the root cause of the company's ibuprofen import problem. Ethyl, which produces the pharmaceutical in Orangeburg, S.C., is the sole U.S. producer of bulk ibuprofen, the popular anti-inflammatory ...