Physical and chemical characterization of mefenamic acid in different pharmaceutical dosage forms and their stability studies using novel RP-HPLC method

Shah, Shabana Naz; Mirza, Agha Zeeshan; Shamshad, Hina; Shafi, Nighat; Naz, Malik Asia

doi:10.1007/s00044-011-9897-5

Cited by 9 publications

(1 citation statement)

References 15 publications

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“…[11][12][13][14] The HPLC system was composed of a pump (LC-10AS; Shimadzu Co., Kyoto, Japan), an auto-injector (SIL-10A, Shimadzu Co.), a UV detector (SPD-10A, Shimadzu Co.), an analysis system (Smart Chrom, KYA TECH Co., Tokyo, Japan), and a column. A C8 column (COSMOSIL 5C8-MS, 5 µm, 4.6×150 mm; Nacalai Tesque, Kyoto, Japan) was used for mexletine and a C18 column (TSKgel ODS-100V, 3 µm, 4.6×150 mm, Tosoh Co., Tokyo, Japan) was used for the other drugs.…”

Section: Determination Of Content Uniformitymentioning

confidence: 99%

Application of Response Surface Methodology to Estimate the Design Space of Pharmaceutical Diluents for Dispensing Powdered Formulations

Miyazaki

Takayama

Uchino

et al. 2016

CHEMICAL & PHARMACEUTICAL BULLETIN

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Scientific approaches for dispensation are important for the quality and efficacy of drug treatments. Therefore, for the dispensation of powdered medicines, we have developed a powder blending method using a planetary centrifugal mixer (PCM) to replace the empirical manual method involving a mortar and pestle. The aim of this study was to optimize the formulation of pharmaceutical diluents for dispensing powdered medicines, using PCM. The diluents, composed of powdered lactose, crystalline lactose, and corn starch were assigned to a {3,2}-Simplex Lattice design. Then, the designed diluents were blended with model powders, such as carbazochrome sodium sulfonate powder, rifampicin capsule contents, and crushed sulfasarazine tablets, at ratios of 1 : 4, 1 : 1, and 4 : 1 using PCM at 800 rpm for 60 s at a 20% filling rate. The mixtures were examined for content uniformity relative standard deviation (RSD) and flowability angle of repose (AOR). Response surface methodology was applied to optimize the formulation with the smallest RSD and AOR, and then the design space of desired diluents was estimated. On the basis of the design space, crystalline lactose, the mixture of lactose powder and crystalline lactose at a ratio of 1 : 4, and the mixture of corn starch and crystalline lactose at a ratio of 1 : 4, were suitable diluents for the powdered formulation, the content of the capsules, and the crushed tablets, respectively. The selected diluents were successfully applied to other model medicines showing a sufficient RSD and AOR. This technique could contribute to the development of scientific approaches for dispensation.Key words pharmaceutical diluent; planetary centrifugal mixer; design space; response surface methodology; content uniformityTo ensure the quality of drugs and efficacy of drug treatments, scientific methods must shift from the manual empirical method to a mechanical one even in the case of extemporaneous dispensation. It has been reported that powdered drugs dispensed according to the same recipe showed different efficacies depending on the pharmacist who dispensed the drugs.1) This limitation is the result of dispensing procedures, including powder blending. Therefore, we have proposed a powder blending method using a planetary centrifugal mixer (PCM) instead of the manual method involving a mortar and pestle.2) Recently, Saito et al. reported that PCM was the most appropriate method for the preparation of low-dose tacrolimus because of efficiency and consistent quality.3) PCM is a container mixer without any agitators.4) The closed container rotates while it revolves in the mixer, resulting in more powerful mixing. PCM was well established as an ointment mixer, and was introduced to many pharmacies. Furthermore, Miyazaki et al. have applied PCM to dry-powder coatings with fine particles.5) With PCM, the degree of blending is not influenced by operators who have different technical abilities. In addition, cross-contamination is avoided when a disposable counter is used. 6)Powdered medicines are frequ...

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Section: Determination Of Content Uniformitymentioning

confidence: 99%