Preparation and in vitro evaluation of enteric-coated tablets of rosiglitazone sodium

Pan, Xin-mei; Li, Jie; Gan, Run; Hu, Xiangnan

doi:10.1016/j.jsps.2015.02.018

Cited by 28 publications

(12 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Activity of auranofin after exposure to simulated gastric fluid (SGF) and simulated intestinal fluid (SIF). Simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) were prepared as described earlier 32,49 . Briefly, SGF (pH = 1.2) was prepared by dissolving NaCl (2 g) and pepsin (3.2 g) in 7 mL of concentrated HCl and deionized water was subsequently added to make up a final volume of 1 L. Then, the pH was adjusted to 1.2.…”

Section: Methodsmentioning

confidence: 99%

Auranofin, at clinically achievable dose, protects mice and prevents recurrence from Clostridioides difficile infection

Abutaleb

Seleem

2020

Sci Rep

View full text Add to dashboard Cite

Clostridioides difficile is the leading cause of nosocomial infections and a worldwide urgent public health threat. Without doubt, there is an urgent need for new effective anticlostridial agents due to the increasing incidence and severity of C. difficile infection (CDI). The aim of the present study is to investigate the in vivo efficacy of auranofin (rheumatoid arthritis FDA-approved drug) in a CDI mouse model and establish an adequate dosage for treatment. The effects of increased C. difficile inoculum, and pre-exposure to simulated gastric intestinal fluid (SGF) and simulated intestinal fluid (SIF), on the antibacterial activity of auranofin were investigated. Auranofin's in vitro antibacterial activity was stable in the presence of high bacterial inoculum size compared to vancomycin and fidaxomicin. Moreover, it maintained its anti-C. difficile activity after being exposed to SGF and SIF. Upon testing in a CDI mouse model, auranofin at low clinically achievable doses (0.125 mg/kg and 0.25 mg/kg) significantly protected mice against CDI with 100% and 80% survival, respectively. Most importantly, auranofin (0.125 mg/kg and 0.25 mg/kg) significantly prevented CDI recurrence when compared with vancomycin. Collectively, these results indicate that auranofin could potentially provide an effective, safe and quick supplement to the current approaches for treating CDI. Clostridioides difficile is the worldwide leading cause of nosocomial infections and antibiotic-associated diarrhea 1. A recent report released by the Centers for Disease Control and Prevention (CDC) stated that about 223,900 patients were hospitalized with C. difficile infections (CDI) in the United States in 2017, which was associated with around 12,800 mortality cases and in excess of $1 billion healthcare cost 2. CDI symptoms range from mild to severe watery diarrhea to more severe life threatening complications such as pseudomembranous colitis, toxic megacolon, colon perforation, sepsis, systemic inflammatory response syndrome and shock 3. Disease manifestations are attributed to the toxin-mediated damage elicited by the two major toxins TcdA and TcdB. These toxins catalyze inactivation of host GTPases (Rac, Rho and CDC42) and perturbation of actin cytoskeleton, ultimately causing intense inflammation, loss of tight junctions of the intestinal mucosal layer, enormous fluid secretion, cell rounding and finally necrosis and apoptosis of the colonic mucosal cells 4,5. The incidence and severity of CDI has increased dramatically due to the overuse of antibiotics and the emergence of hypervirulent epidemic strains such as, but not limited to, pulsed-field gel type North American pulsotype 1 (NAP1) or PCR ribotype 027, which were responsible for several outbreaks globally 6,7. Moreover, the clinical management of CDI is hindered by the ability of C. difficile to produce spores which are highly resistant to environmental conditions, antibiotics and disinfection processes. Spores can persist on unsuitable environments for long periods and spread in the e...

show abstract

Section: Methodsmentioning

confidence: 99%

Auranofin, at clinically achievable dose, protects mice and prevents recurrence from Clostridioides difficile infection

Abutaleb

Seleem

2020

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Furthermore, the simulated intestinal fluid was also composed by dissolving potassium phosphate monobasic (10.2 g) and SDS (3.75 g) in a same 1000 mL of DI water and then pH adjusted to 6.8 ± 0.1 with 1 N NaOH. Finally, the volume make-up of each prepared fluid was done up to 1500 mL with DI water [27].…”

Section: Drug Release Profile In Simulated Gastric Fluid (Ph 12) and Simulated Intestinal Fluid (Ph 68)mentioning

confidence: 99%

Formulation and development of Serratiopeptidase enteric coated tablets and analytical method validation by UV Spectroscopy

Panthi

Jha²,

Chaubey³

et al. 2021

International Journal of Analytical Chemistry

View full text Add to dashboard Cite

Serratiopeptidase (SRP) is a proteolytic enzyme that emerged as one of the most potent anti-inflammatory and analgesic drugs. The purpose of the present study was to formulate and evaluate enteric-coated tablets for SRP and investigate their stability using a simple and validated analytical method by ultraviolet (UV) spectroscopy. The colloidal silicon dioxide (2.50%), sodium starch glycolate (3.44%), and crospovidone (2.50%) were used as appropriate excipients for the development of core part of tablets. To protect the prepared tablets from acidic environment in the stomach, white shellac, castor oil, HPMC phthalate 40, and ethyl cellulose were used. The seal coating and enteric coating attained were 2.75% and 6.74%, respectively. SRP was found to be linear at 265 nm in the concentration range of 25–150 µg/mL. The results revealed that our developed method was linear (R2 = 0.999), precise (RSD % = 0.133), and accurate (% recovery = 99.96–103.34). The formulated SRP tablets were found to be stable under accelerated conditions as well as under room temperature for 6 months (assay %: >97.5%). The in vitro drug release study demonstrated that enteric-coated tablets were able to restrict SRP release in both acidic environments: 0.1 N HCl and simulated gastric fluid (pH 1.2). Moreover, at 60 minutes, the formulated SRP tablets revealed 13.0% and 8.98% higher drug release in phosphate buffer (pH 6.8) and simulated intestinal fluid (pH 6.8), respectively, compared to the marketed tablet formulation. This study concludes that enteric-coated tablets of SRP with higher drug release in the intestine can be prepared and examined for their stability using validated analytical technique of UV spectroscopy.

show abstract

“…An enteric platform is usually based on pH sensitive polymers which are insoluble at low pH (1-5.5), but start to dissolve at a pH above 5.5 by salt formation (Albanez et al, 2013). The enteric/delayed release is well-known practice in the pharmaceutical industry, where polymers are applied in form of thin films over different types of cores such as tablets, capsules or most often MDDS (Pan et al, 2015;Huyghebaert et al, 2004;Dukić-Ott et al, 2008). However, film-coating is time consuming process with several process steps required to obtain the final product.…”

Section: Targeted Oral Dosage Formsmentioning

confidence: 99%

Hot-melt extrusion and prilling as contemporary and promising techniques in the solvent free production of solid oral dosage forms, based on solid dispersions

Aleksovski¹,

Vervaet²,

Dreu³

2016

Maced. Pharm. Bull.

View full text Add to dashboard Cite

Hot melt extrusion and prilling are gaining importance as solvent free and continuous techniques in the production of solid oral dosage forms with added value, by incorporating active compound in a molten carrier which is further solidified to form solid dispersion. This article reviews these two techniques in terms of understanding process basics, equipment characteristics, required properties of processed materials and application of the processes for development of solid oral dosage forms. Studies revealed that both hot-melt extrusion and prilling are regarded as simple, robust and continuous methods for processing different types of materials and production of solid dosage forms based on solid matrices. However, understanding of their concepts and requirements together with careful material selection is crucial for stable material processing and obtaining stable products of high-quality. Hot-melt extrusion proved to be a suitable method for production of modified release dosage forms, taste masked dosage forms and dosage forms offering improved drug dissolution rate and solubility. Prilling till now has been successfully applied just in the production of multiple unit drug delivery systems for immediate and sustained drug delivery. Further studies on product development and process understanding are required for full implementation of prilling in the pharmaceutical field.

show abstract

Preparation and in vitro evaluation of enteric-coated tablets of rosiglitazone sodium

Cited by 28 publications

References 7 publications

Auranofin, at clinically achievable dose, protects mice and prevents recurrence from Clostridioides difficile infection

Auranofin, at clinically achievable dose, protects mice and prevents recurrence from Clostridioides difficile infection

Formulation and development of Serratiopeptidase enteric coated tablets and analytical method validation by UV Spectroscopy

Hot-melt extrusion and prilling as contemporary and promising techniques in the solvent free production of solid oral dosage forms, based on solid dispersions

Contact Info

Product

Resources

About