Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method

Abstract Background Eosinophilic Esophagitis is an increasing pathology which can cause stomach symptom like dysphagia, vomiting, food blockage. The treatment consists in dietary therapy and topical corticosteroid therapy to avoid the important number of side effects of the oral corticosteroids. There is presently no available topical form adapted for treating esophageal pathology. Methods The aim of this work was to develop an oral viscous budesonide gel (OVBG). A focus on palatability was made in order to use OVBG in children. A stability indicating HLPC method able to quantify budesonide contained in our OVBG has been developed. Results Previous work of Hefner and Al. showed that xanthan gum had a longer esophageal mucosal contact time than sucralose. This encouraged the development of a xanthan gum-based formulation. This OVBG has also the advantage to facilitate compliance thanks to its taste and pleasant texture. The stability length of the preparation can be extended over a 3-months period, stored in a refrigerator at 2–8 °C. Conclusion An adapted pediatric formulation with a 3-months stability was developed. Furthermore, the formulation can be easily reproduced in community pharmacy. Regarding the increasing number of patients concerned OVBG is a good answer to a real clinical need.

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Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and valsartan

Acta Pharmaceutica ◽

10.2478/acph-2014-0037 ◽

2014 ◽

Vol 64 (4) ◽

pp. 463-474 ◽

Cited By ~ 5

Author(s):

Monika Musko ◽

Malgorzata Sznitowska

Keyword(s):

Active Substance ◽

Microscopic Observation ◽

Xanthan Gum ◽

Candesartan Cilexetil ◽

Pediatric Population ◽

Oral Solution ◽

Expiry Date ◽

The Stability ◽

Made In

Abstract Available tablets or capsules for adults are often used to prepare extemporaneously formulated medicines appropriate for children. The most acceptable drug forms in pediatric population are oral liquids and pharmacists use commercial dispersing media to compound syrups from an active substance or from tablets available on the market. In many countries ready-to-use dispersing media are not available or refunded, but pharmacists can use other compounded media, providing their compatibility and stability are proven. The aim of this study was to formulate and evaluate the stability of syrups with candesartan cilexetil (1 mg mL-1) and valsartan (4 mg mL-1) extemporaneously prepared using commercial tablets (Diovan® and Atacand®). The following three different suspending media, which could be easily made in a pharmacy, were investigated: V1 - with xanthan gum (0.5 %), V2 - the USP/NF vehicle for oral solution and V3 - the medium based on a simple sucrose syrup. The stability of preparations was studied during 35 days of storage in a dark place at controlled temperature of 25 and 4 °C. During the study, microscopic observation was carried out and pH, viscosity, and concentration of candesartan cilexetil and valsartan were analyzed. Syrups with valsartan prepared with V2 and V3 media were stable for 3 or 4 weeks when stored at 25 °C, while syrups with candesartan were stable for as long as 35 days. For syrups prepared using V1 medium, the 14-day expiry date was not achieved because of microbial deterioration.

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Imaging of Bacteria: Is there Any Hope for the Future Based on Past Experience?

Current Pharmaceutical Design ◽

10.2174/1381612823666171122111558 ◽

2018 ◽

Vol 24 (7) ◽

pp. 772-786 ◽

Cited By ~ 4

Author(s):

Thomas Ebenhan ◽

Elena Lazzeri ◽

Olivier Gheysens

Keyword(s):

Clinical Practice ◽

Sterile Inflammation ◽

Ageing Population ◽

Major Health Problem ◽

Major Health ◽

Number Of Patients ◽

Implanted Medical Devices ◽

Neutropenic Patients ◽

Socio Economic Impact ◽

Made In

Infectious diseases remain a major health problem and cause of death worldwide. It is expected that the socio-economic impact will further intensify due to escalating resistance to antibiotics, an ageing population and an increase in the number of patients under immunosuppressive therapy and implanted medical devices. Even though radiolabeled probes and leukocytes are routinely used in clinical practice, it might still be difficult to distinguish sterile inflammation from inflammation caused by bacteria. Moreover, the majority of these probes are based on the attraction of leukocytes which may be hampered in neutropenic patients. Novel approaches that can be implemented in clinical practice and allow for swift diagnosis of infection by targeting the microorganism directly, are posing an attractive strategy. Here we review the current strategies to directly image bacteria using radionuclides and we provide an overview of the preclinical efforts to develop and validate new approaches. Indeed, significant progress has been made in the past years, but very few radiopharmaceuticals (that were promising in preclinical studies) have made it into clinical practice. We will discuss the challenges that remain to select good candidates for imaging agents targeting bacteria.

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Influence of Whey Protein Micro-Gel Particles and Whey Protein Micro-Gel Particles-Xanthan Gum Complexes on the Stability of O/W Emulsions

Polymers ◽

10.3390/polym13142301 ◽

2021 ◽

Vol 13 (14) ◽

pp. 2301

Author(s):

Man Zhang ◽

Bin Liang ◽

Hongjun He ◽

Changjian Ji ◽

Tingting Cui ◽

...

Keyword(s):

Oxidative Stability ◽

Whey Protein ◽

High Speed ◽

Xanthan Gum ◽

Physical Stability ◽

Theoretical Support ◽

Gel Particles ◽

Oil In Water ◽

The Stability ◽

The Impact

Appropriate pretreatment of proteins and addition of xanthan gum (XG) has the potential to improve the stability of oil-in-water (O/W) emulsions. However, the factors that regulate the enhancement and the mechanism are still not clear, which restricts the realization of improving the emulsion stability by directional design of its structure. Therefore, the effects of whey protein micro-gel particles (WPMPs) and WPMPs-XG complexes on the stability of O/W emulsion were investigated in this article to provide theoretical support. WPMPs with different structures were prepared by pretreatment (controlled high-speed shear treatment of heat-set WPC gels) at pH 3.5–8.5. The impact of initial WPC structure and XG addition on Turbiscan Indexes, mean droplet size and the peroxide values of O/W emulsions was investigated. The results indicate that WPMPs and XG can respectively inhibit droplet coalescence and gravitational separation to improve the physical stability of WPC-stabilized O/W emulsions. The pretreatment significantly enhanced the oxidative stability of WPC-stabilized O/W emulsions. The addition of XG did not necessarily enhance the oxidative stability of O/W emulsions. Whether the oxidative stability of the O/W emulsion with XG is increased or decreased depends on the interface structure of the protein-XG complex. This study has significant implications for the development of novel structures containing lipid phases that are susceptible to oxidation.

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Infra-popliteal deep venous thrombi and the risk of symptomatic pulmonary embolism in hospitalized patients

Vascular ◽

10.1258/vasc.2010.oa0252 ◽

2011 ◽

Vol 19 (1) ◽

pp. 29-33 ◽

Cited By ~ 5

Author(s):

Saadi Alhalbouni ◽

Anil Hingorani ◽

Alexander Shiferson ◽

Natalie Marks ◽

Enrico Ascher

Keyword(s):

Pulmonary Embolism ◽

Lower Extremity ◽

Retrospective Review ◽

Lower Limb ◽

Hospitalized Patients ◽

Symptomatic Pulmonary Embolism ◽

Number Of Patients ◽

Significant Difference ◽

Hospital Patients ◽

Made In

Infra-popliteal veins include the tibial and peroneal veins, as well as the soleal and gastrocnemial veins collectively known as the calf muscle veins (CMVs). Acute infra-popliteal deep venous thrombi (DVTs) are often considered insignificant with regard to the risk of pulmonary embolism (PE). A retrospective review of 4035 consecutive lower extremity venous duplex scans were made in 3146 hospital patients at our Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL)-accredited vascular lab. Seven hundred sixteen (17.7%) duplex scans were positive for acute DVTs, and 112 (2.8%) were associated with PEs. The breakdown of positive duplexes for acute DVTs was as follows: 202 (28.2%) isolated femoral-popliteal DVTs with PE in 23 (11.4%), 304 (42.5%) isolated infra-popliteal DVTs with PE in 24 (7.9%) and 210 (29.3%) multilevel DVTs involving both vein segments (femoral-popliteal and infra-popliteal) with PE in 38 (18.1%). Of the 304 isolated acute infra-popliteal DVTs, 207 (68.1%) were isolated CMV DVTs with evidence of PE in 12 (5.8%). No statistically significant difference ( P = 0.27) in the risk of PE between isolated femoral-popliteal and isolated infra-popliteal DVTs was noted. A significant number of patients (5.8%) with isolated CMV DVTs developed PE. Lower limb venous scans for DVTs should evaluate the infra-popliteal veins. Hospitalized patients with infra-popliteal DVTs should receive anticoagulation.

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Workshop 1: Differential Diagnosis

International Psychogeriatrics ◽

10.1017/s1041610297004742 ◽

1997 ◽

Vol 9 (S1) ◽

pp. 85-86

Author(s):

Martin Rossor

Keyword(s):

Differential Diagnosis ◽

Cognitive Impairment ◽

Memory Impairment ◽

The Other ◽

Neuropsychological Measures ◽

Clinical Criteria ◽

Dementia Syndrome ◽

Number Of Patients ◽

Diagnostic Modalities ◽

Made In

We were asked to consider differential diagnosis. We decided that it really is different from the other diagnostic modalities and cannot be treated in the same way as, for example, global or neuropsychological measures. In the context of this meeting, we believed it would be appropriate to consider clinical criteria. Thus, clinical criteria for the dementia syndrome as well as for specific diseases were discussed. We recognized that in the future, an increasing number of patients will present with cognitive impairment who do not fulfill the clinical criteria for dementia. These patients may alternatively have an isolated memory impairment syndrome. Nevertheless, a diagnosis will still need to be made in these patients, at least in terms of the underlying molecular pathology, in order to implement potential treatments.

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Effects of Load and Contact Time on the Stability of Bimolecular Integrin-Fibrinogen Bonds Under a Constant Tensile Force

Biophysical Journal ◽

10.1016/j.bpj.2008.12.3113 ◽

2009 ◽

Vol 96 (3) ◽

pp. 595a

Author(s):

Rustem I. Litvinov ◽

Joel S. Bennett ◽

John W. Weisel ◽

Henry Shuman

Keyword(s):

Contact Time ◽

Tensile Force ◽

The Stability

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Assessment of Fennel Oil Microfluidized Nanoemulsions Stabilization by Advanced Performance Xanthan Gum

Foods ◽

10.3390/foods10040693 ◽

2021 ◽

Vol 10 (4) ◽

pp. 693

Author(s):

Rubén Llinares ◽

Pablo Ramírez ◽

José Antonio Carmona ◽

Luis Alfonso Trujillo-Cayado ◽

José Muñoz

Keyword(s):

Essential Oil ◽

Rheological Properties ◽

Xanthan Gum ◽

Mechanical Energy ◽

Physical Stability ◽

Processing Condition ◽

Oil In Water ◽

Mechanical Spectra ◽

The Stability ◽

Fennel Oil

In this work, nanoemulsion-based delivery system was developed by encapsulation of fennel essential oil. A response surface methodology was used to study the influence of the processing conditions in order to obtain monomodal nanoemulsions of fennel essential oil using the microchannel homogenization technique. Results showed that it was possible to obtain nanoemulsions with very narrow monomodal distributions that were homogeneous over the whole observation period (three months) when the appropriate mechanical energy was supplied by microfluidization at 14 MPa and 12 passes. Once the optimal processing condition was established, nanoemulsions were formulated with advanced performance xanthan gum, which was used as both viscosity modifier and emulsion stabilizer. As a result, more desirable results with enhanced physical stability and rheological properties were obtained. From the study of mechanical spectra as a function of aging time, the stability of the nanoemulsions weak gels was confirmed. The mechanical spectra as a function of hydrocolloid concentration revealed that the rheological properties are marked by the biopolymer network and could be modulated depending on the amount of added gum. Therefore, this research supports the role of advanced performance xanthan gum as a stabilizer of microfluidized fennel oil-in-water nanoemulsions. In addition, the results of this research could be useful to design and formulate functional oil-in-water nanoemulsions with potential application in the food industry for the delivery of nutraceuticals and antimicrobials.

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COMMITTEE ON NUTRITION

PEDIATRICS ◽

10.1542/peds.40.2.289 ◽

1967 ◽

Vol 40 (2) ◽

pp. 289-304

Author(s):

CHARLES U. LOWE ◽

DAVID BAIRD COURSIN ◽

FELIX P. HEALD ◽

MALCOLM A. HOLLIDAY ◽

DONOUGH O'BRIEN ◽

...

Keyword(s):

Metabolic Disease ◽

Metabolic Diseases ◽

Dietary Treatment ◽

Nutritional Therapy ◽

The United States ◽

Detection Methods ◽

Dietary Therapy ◽

Treatment Practices ◽

Hereditary Metabolic Diseases ◽

Number Of Patients

THIRTEEN YEARS AGO a dietary approach to the therapy of phenylketonuria was proposed, and data on the usefulness as well as the very real limitations of this program have accumulated in the intervening years. At the present time studies on the application of special diets for use in this disease, as well as for many other hereditary metabolic diseases, are in progress. As wider use is made of procedures for detection of hereditary metabolic disease in the newborn, an increasingly larger number of patients who may benefit from appropriate nutritional therapy will be identified very early in life. For example, calculations based on the current birth rate and apparent incidence of phenylketonuria indicate that as many as 4,000 infants with this disorder in the United States alone could require dietary therapy in the next decade. There is, therefore, a need to evaluate the principles governing nutritional management of hereditary metabolic disease in order to develop optimal treatment facilities for use in conjunction with new detection methods. It seems anomalous that comparatively little has been done either to establish good treatment practices in hereditary metabolic disease or to mobilize scientific resources to ensure an optimistic out-come for therapeutic endeavors, while so much emphasis has been placed on detection. Dietary treatment of hereditary metabolic disease is simple in theory; however, practical application may be unexpectedly difficult, or even hazardous, if not carefully supervised. It should be determined whether: (1) the untreated disease is in fact harmful, (2) the treatment is useful in preventing or reversing the unfavorable progression of the disease, (3) the therapy may be harmful by interfering with growth or development, and (4) the program may be harmful to others to whom it is inadvertently or inappropriately given.

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A New, Rapid and Simple RP-HPLC Method for Stability Quantification of a Protease Inhibitor in Tablets

Journal of Chromatographic Science ◽

10.1093/chromsci/bmab109 ◽

2021 ◽

Author(s):

Rochele Cassanta Rossi ◽

Josué Guilherme Lisbôa Moura ◽

Vanessa Mossmann ◽

Patrícia Weimer ◽

Pedro Eduardo Fröehlich

Keyword(s):

Quality Control ◽

Protease Inhibitor ◽

Degradation Products ◽

Gradient Elution ◽

Hplc Method ◽

Array Detector ◽

Forced Degradation ◽

Control Analysis ◽

Quality Control Laboratory ◽

The Stability

Abstract Fosamprenavir calcium is a protease inhibitor widely used in the treatment and prevention of human immunodeficiency virus and acquired immunodeficiency syndrome. This protease inhibitor serves as a prodrug of amprenavir, offering better oral bioavailability. Although this drug was approved by the FDA in 2003, there are few methods established for quantifying the stability for quality control analysis of fosamprenavir-coated tablets. The purpose of the study was to develop and validate a method for determining the stability of fosamprenavir-coated tablets (Telzir®) that may be applied by any quality control laboratory. Chromatographic separation was performed using a Vertical RP-18 column programmed to run a gradient elution with sodium acetate buffer and acetonitrile. Flow rate was 1.2 mL min−1 for a total run time of 15 min. Ultraviolet detection was set at 264 nm and the use of a photodiode array detector in scan mode allowed selectivity confirmation by peak purity evaluation. The analyte peak was found to be adequately separated from degradation products generated during forced degradation studies. Thus, the proposed method was found to accurately indicate stability and was sufficient for routine quantitative analysis of fosamprenavir in coated tablets without interference from major degradation products and excipients.

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Electrolysis soy protein isolate-based oleogels prepared with an emulsion-templated approach

International Journal of Food Engineering ◽

10.1515/ijfe-2021-0076 ◽

2021 ◽

Vol 0 (0) ◽

Author(s):

Dianyu Yu ◽

Yan Chen ◽

Xing Chen ◽

Yunyan Huang ◽

Liqi Wang ◽

...

Keyword(s):

Soy Protein ◽

Xanthan Gum ◽

Binding Capacity ◽

Soy Protein Isolate ◽

Single Layer ◽

Protein Isolate ◽

Regulatory Limits ◽

Order Of Magnitude ◽

The Stability ◽

Oil Binding

Abstract This research focuses on the use of protein-polyphenol complex and protein-polyphenol: polysaccharide complexes to prepare oleogels through an emulsion-templated approach. Electrolysis soy protein isolate (ESPI) could be effectively adsorbed on the surface of a single-layer emulsion to increase the particle size. The order of the negative charges of the emulsion after adding polysaccharides was xanthan gum (XG)> pectin> carboxymethyl cellulose (CMC). Rheological behavior showed that the stability of the double-layer emulsions increased, and the viscoelasticity increased around one order of magnitude with the addition of polysaccharides. The oil binding capacity (OBC) of the oleogel prepared by adding polysaccharides increased to more than 97%. The peroxide value (PV) and anisidine value (AV) of XG oleogel were the minimum values in all samples. The AV and POV were within the regulatory limits of China after storage for 21 days. This provides a reference to design of ESPI-based oleogel for different applications.

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