scholarly journals Study of the Stability of a Viscous Solution of Naftifin Hydrochloride with a Combination of Polyethylene Glycols for External Use

2020 ◽  
Vol 9 (2) ◽  
pp. 67-71
Author(s):  
S. I. Kosenkova ◽  
I. I. Krasnyuk ◽  
I. I. Krasnyuk (jr.) ◽  
A. V. Belyatskaya ◽  
O. I. Stepanova ◽  
...  
Keyword(s):  
Shelf Life ◽  
Dosage Form ◽  
Wide Spectrum ◽  
Alcohol Solution ◽  
Polyethylene Glycols ◽  
Uv Spectrophotometry ◽  
Viscous Solution ◽  
The Stability ◽  
Hydrochloride Solution

Introduction. An innovative antifungal viscous solution based on naftifine hydrochloride with a combination of polyethylene glycols (PEG) was developed in the laboratory of Sechenov University. The developed preparation intended for external use. The active ingredient – naftifine hydrochloride has a wide spectrum of action against fungi cause onychomycosis. The polyethylene glycols are included in the developed dosage form of provide the necessary viscosity of the solution (for accurate application and retention in the field of application). The paper presents the results of a study of the stability of a viscous solution of naftifine hydrochloride with a combination of PEG for external use. Over the entire shelf life, the drug must retain the full its chemical, physical, biopharmaceutical and pharmacological properties.Aim. Determination of stability and expiration date of the shelf life of the developed solution of naftifine hydrochloride for external use, intended for the treatment of mycosis of the nail.Materials and methods. Naftifine hydrochloride solution, «Millipor» filter, UV spectrophotometry, potentiometry pH, capillary viscometry.Results and discussion. In the course of the study, the shelf life of the developed alcohol solution of naftifin hydrochloride with a combination of PEG was experimentally determined. The stability of the dosage form was determined by accelerated aging at a temperature of 40 ± 2 °C, in vivo at a temperature of no higher than 25 °C; and in a refrigerator at a temperature of 8 ± 2 °C. Assessment of the stability of the alcohol solution of naftifine hydrochloride was carried out according to the following indicators: the volume of the contents of the bottle, appearance, pH, quantitative content of the active substance, viscosity.Conclusion. Based on the studies, it is recommended to store the naftifine hydrochloride solution at room temperature not higher than 25 °C, in a dark place. It is also allowed to store the solution of naftifine hydrochloride in a refrigerator at a temperature of 8 ± 2 °C.

scholarly journals Clinical Application and Efficacy of Silver Drug in Ophthalmology: A Literature Review and New Formulation of EYE Drops with Drug Silver (I) Complex of Metronidazole with Improved Dosage Form

Biomedicines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 210
Author(s):  
Arleta Waszczykowska ◽  
Dominik Żyro ◽  
Justyn Ochocki ◽  
Piotr Jurowski
Keyword(s):  
Dosage Form ◽  
Complex Analysis ◽  
Bacterial Resistance ◽  
Eye Drops ◽  
Ophthalmic Diseases ◽  
The Stability ◽  
New Formulation ◽  
Additional Therapy ◽  
Antibacterial Potential

The use of silver preparations in medicine is becoming increasingly popular. The basic aim of this evaluation was to review the literature on the clinical (in vivo) and antibacterial potential of silver preparations in ophthalmic diseases. The second goal was to summarize the results of experimental research on the use of silver preparations in ophthalmology. The third objective was to present a method for stabilizing eye drops containing silver (I) complex. Analysis of the pH stability of the silver (I) complex with metronidazole in the prepared dosage form (eye drops) was carried out. Most silver preparations are clinically used for topical application. Few experimental results indicate the usefulness of intraocular or systemic administration of silver (I) preparations as an alternative or additional therapy in infectious and angiogenic eye diseases. The development of a new formulation increases the stability of the dosage form. New forms of silver (I) products will certainly find application in the treatment of many ophthalmic diseases. One of the most important features of the silver (I) complex is its capacity to break down bacterial resistance. The new eye drops formula can significantly improve comfort of use. Due to their chemical nature, silver (I) compounds are difficult to stabilize, especially in the finished dosage form.

STUDIES TO DETERMINE SHELF LIFE AND STORAGE CONDITIONS WOUND HEALING GEL WITH CYCVALONE

2021 ◽  
pp. 54-59
Author(s):  
Petrukhina D.A. ◽  
Pletneva I.V. ◽  
Pokrovskaya Y.S.
Keyword(s):  
Wound Healing ◽  
Dosage Form ◽  
Potassium Hydroxide Solution ◽  
Storage Conditions ◽  
Pharmaceutical Products ◽  
Rheological Parameters ◽  
Long Term Storage ◽  
Antioxidant Agent ◽  
The Stability

One of the urgent tasks in the process of drug development is to obtain stable pharmaceutical products in the process of storage and use. To establish the expiration date, it is necessary to determine the time during which the developed drug is able to maintain stability and meet all the requirements stated in the regulatory documentation. The aim of the study was to study the stability of laboratory samples of wound healing gel with cycvalone during long-term storage in natural conditions. The developed composition of the wound healing gel includes the antioxidant agent cycvalone, which has a pronounced manifestation of antioxidant and anti-radical activity, as well as has a wound healing, immunotropic and anti-inflammatory effect. Carbomer (Carbopol-940), potassium hydroxide solution and purified water were used as excipients. Gel samples were stored in the primary packaging at room temperature in a place protected from light. The stability of the dosage form was studied according to the following parameters: description, pH of water extraction, authenticity, colloidal and thermal stability, quantitative determination, rheological parameters in accordance with the developed methods. The measurement was performed on 6 series of dosage forms: after preparation, after 6, 12, 18 and 24 months of storage in vivo. The results of determining the quality indicators of the wound healing gel with an antioxidant agent (cycvalone) indicate a rational selection of active and auxiliary substances and their concentration, the choice of a rational technology and the absence of interaction between the components of the developed dosage form. Based on the conducted studies, it is proved that the wound healing gel with cycvalone remains stable during storage at a temperature of 15 to 25 ˚С for 24 months.

Characterization of the human proliferating cell nuclear antigen physico-chemical properties: aspects of double trimer stability

2006 ◽  
Vol 84 (5) ◽  
pp. 669-676 ◽  
Author(s):  
Stanislav N. Naryzhny ◽  
Leroi V. DeSouza ◽  
K.W. Michael Siu ◽  
Hoyun Lee
Keyword(s):  
Proliferating Cell Nuclear Antigen ◽  
Wide Spectrum ◽  
Gel Filtration ◽  
Chemical Properties ◽  
Nuclear Antigen ◽  
Physico Chemical ◽  
The Stability ◽  
Proliferating Cell

Its toroidal structure allows the proliferating cell nuclear antigen (PCNA) to wrap around and move along the DNA fiber, thereby dramatically increasing the processivity of DNA polymerization. PCNA is also involved in the regulation of a wide spectrum of other biological functions, including epigenetic inheritance. We have recently reported that mammalian PCNA forms a double trimer complex, which may be critically important in coordinating DNA replication and other cellular functions. To gain a better understanding of the stability of PCNA complexes, we characterized the physico-chemical properties of the PCNA structure by in vivo and in vitro approaches. The data obtained by gel filtration and nondenaturing gel electrophoresis of native PCNA molecules confirm our previous observations, obtained using formaldehyde crosslinking, in which PCNA exists in the cell as a double trimer. We have also found that optimal pH (pH 6.5–7.5) is critical for the stability of the PCNA structure. The presence or absence of ATP, dithiothreitol, and Mg2+ does not affect the stability of the PCNA trimer or double trimer. However, 0.02% SDS can effectively inhibit PCNA double trimer, but not single trimer, formation. Interestingly, glycerol and ammonium sulfate significantly destabilize both PCNA trimer and double trimer structures.

scholarly journals Shelf-Life Extension of Fc-Fused Single Chain Fragment Variable Antibodies by Lyophilization

2021 ◽  
Vol 11 ◽  
Author(s):  
Kai-Thomas Schneider ◽  
Toni Kirmann ◽  
Esther Veronika Wenzel ◽  
Jan-Hendrik Grosch ◽  
Saskia Polten ◽  
...  
Keyword(s):  
Phage Display ◽  
Shelf Life ◽  
Neutralizing Antibodies ◽  
Binding Activity ◽  
Life Extension ◽  
Market Demand ◽  
Single Chain ◽  
Single Chain Fv ◽  
The Stability

Generation of sequence defined antibodies from universal libraries by phage display has been established over the past three decades as a robust method to cope with the increasing market demand in therapy, diagnostics and research. For applications requiring the bivalent antigen binding and an Fc part for detection, phage display generated single chain Fv (scFv) antibody fragments can rapidly be genetically fused to the Fc moiety of an IgG for the production in eukaryotic cells of antibodies with IgG-like properties. In contrast to conversion of scFv into IgG format, the conversion to scFv-Fc requires only a single cloning step, and provides significantly higher yields in transient cell culture production than IgG. ScFv-Fcs can be effective as neutralizing antibodies in vivo against a panel of pathogens and toxins. However, different scFv fragments are more heterologous in respect of stability than Fab fragments. While some scFv fragments can be made extremely stable, this may change due to few mutations, and is not predictable from the sequence of a newly selected antibody. To mitigate the necessity to assess the stability for every scFv-Fc antibody, we developed a generic lyophilization protocol to improve their shelf life. We compared long-term stability and binding activity of phage display-derived antibodies in the scFv-Fc and IgG format, either stored in liquid or lyophilized state. Conversion of scFv-Fcs into the full IgG format reduced protein degradation and aggregation, but in some cases compromised binding activity. Comparably to IgG conversion, lyophilization of scFv-Fc resulted in the preservation of the antibodies’ initial properties after storage, without any drop in affinity for any of the tested antibody clones.

Formation and Structure of Casein Micelles in Lactating Mammary Tissue

1970 ◽  
Vol 28 ◽  
pp. 150-151
Author(s):  
Robert J. Carroll ◽  
Marvin P. Thompson ◽  
Harold M. Farrell
Keyword(s):  
Size Distribution ◽  
G Protein ◽  
Milk Proteins ◽  
Mammary Tissue ◽  
Colloidal System ◽  
Casein Micelles ◽  
The Stability

Milk is an unusually stable colloidal system; the stability of this system is due primarily to the formation of micelles by the major milk proteins, the caseins. Numerous models for the structure of casein micelles have been proposed; these models have been formulated on the basis of in vitro studies. Synthetic casein micelles (i.e., those formed by mixing the purified αsl- and k-caseins with Ca2+ in appropriate ratios) are dissimilar to those from freshly-drawn milks in (i) size distribution, (ii) ratio of Ca/P, and (iii) solvation (g. water/g. protein). Evidently, in vivo organization of the caseins into the micellar form occurs in-a manner which is not identical to the in vitro mode of formation.

Kinetics of Various 99mTc-Sn-Pyrophosphate Compounds in the Rat

1977 ◽  
Vol 16 (04) ◽  
pp. 157-162 ◽  
Author(s):  
C. Schümichen ◽  
B. Mackenbrock ◽  
G. Hoffmann
Keyword(s):  
Normal Saline ◽  
Half Life ◽  
Compound A ◽  
Short Half Life ◽  
Low Concentrations ◽  
The Stability ◽  
Kinetics Of ◽  
In Vitro Stability

SummaryThe bone-seeking 99mTc-Sn-pyrophosphate compound (compound A) was diluted both in vitro and in vivo and proved to be unstable both in vitro and in vivo. However, stability was much better in vivo than in vitro and thus the in vitro stability of compound A after dilution in various mediums could be followed up by a consecutive evaluation of the in vivo distribution in the rat. After dilution in neutral normal saline compound A is metastable and after a short half-life it is transformed into the other 99mTc-Sn-pyrophosphate compound A is metastable and after a short half-life in bone but in the kidneys. After dilution in normal saline of low pH and in buffering solutions the stability of compound A is increased. In human plasma compound A is relatively stable but not in plasma water. When compound B is formed in a buffering solution, uptake in the kidneys and excretion in urine is lowered and blood concentration increased.It is assumed that the association of protons to compound A will increase its stability at low concentrations while that to compound B will lead to a strong protein bond in plasma. It is concluded that compound A will not be stable in vivo because of a lack of stability in the extravascular space, and that the protein bond in plasma will be a measure of its in vivo stability.

Significance of In-Vitro and In-Vivo Correlation in Drug Delivery System

2018 ◽  
Vol 4 (4) ◽  
pp. 523-531
Author(s):  
Hina Mumtaz ◽  
Muhammad Asim Farooq ◽  
Zainab Batool ◽  
Anam Ahsan ◽  
Ashikujaman Syed
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparations ◽  
Pharmacokinetic Profile ◽  
In Vitro Dissolution ◽  
Time Saving ◽  
Pharmaceutical Dosage Form ◽  
Short Period ◽  
Form Development

The main purpose of development pharmaceutical dosage form is to find out the in vivo and in vitro behavior of dosage form. This challenge is overcome by implementation of in-vivo and in-vitro correlation. Application of this technique is economical and time saving in dosage form development. It shortens the period of development dosage form as well as improves product quality. IVIVC reduce the experimental study on human because IVIVC involves the in vivo relevant media utilization in vitro specifications. The key goal of IVIVC is to serve as alternate for in vivo bioavailability studies and serve as justification for bio waivers. IVIVC follows the specifications and relevant quality control parameters that lead to improvement in pharmaceutical dosage form development in short period of time. Recently in-vivo in-vitro correlation (IVIVC) has found application to predict the pharmacokinetic behaviour of pharmaceutical preparations. It has emerged as a reliable tool to find the mode of absorption of several dosage forms. It is used to correlate the in-vitro dissolution with in vivo pharmacokinetic profile. IVIVC made use to predict the bioavailability of the drug of particular dosage form. IVIVC is satisfactory for the therapeutic release profile specifications of the formulation. IVIVC model has capability to predict plasma drug concentration from in vitro dissolution media.

The stability and shelf-life of food

2000 ◽  
Author(s):  
David Kilcast ◽  
Persis Subramaniam
Keyword(s):  
Shelf Life ◽  
The Stability

Applicability of Instability Index for In vitro Protein Stability Prediction

2019 ◽  
Vol 26 (5) ◽  
pp. 339-347 ◽  
Author(s):  
Dilani G. Gamage ◽  
Ajith Gunaratne ◽  
Gopal R. Periyannan ◽  
Timothy G. Russell
Keyword(s):  
Protein Stability ◽  
Caulobacter Crescentus ◽  
Effect Of Temperature ◽  
Instability Index ◽  
Dipeptide Composition ◽  
Experimental Conditions ◽  
The Stability ◽  
Vitro Protein

Background: The dipeptide composition-based Instability Index (II) is one of the protein primary structure-dependent methods available for in vivo protein stability predictions. As per this method, proteins with II value below 40 are stable proteins. Intracellular protein stability principles guided the original development of the II method. However, the use of the II method for in vitro protein stability predictions raises questions about the validity of applying the II method under experimental conditions that are different from the in vivo setting. Objective: The aim of this study is to experimentally test the validity of the use of II as an in vitro protein stability predictor. Methods: A representative protein CCM (CCM - Caulobacter crescentus metalloprotein) that rapidly degrades under in vitro conditions was used to probe the dipeptide sequence-dependent degradation properties of CCM by generating CCM mutants to represent stable and unstable II values. A comparative degradation analysis was carried out under in vitro conditions using wildtype CCM, CCM mutants and two other candidate proteins: metallo-β-lactamase L1 and α -S1- casein representing stable, borderline stable/unstable, and unstable proteins as per the II predictions. The effect of temperature and a protein stabilizing agent on CCM degradation was also tested. Results: Data support the dipeptide composition-dependent protein stability/instability in wt-CCM and mutants as predicted by the II method under in vitro conditions. However, the II failed to accurately represent the stability of other tested proteins. Data indicate the influence of protein environmental factors on the autoproteolysis of proteins. Conclusion: Broader application of the II method for the prediction of protein stability under in vitro conditions is questionable as the stability of the protein may be dependent not only on the intrinsic nature of the protein but also on the conditions of the protein milieu.

Anthocyanins As Modulators of Cell Redox-Dependent Pathways in Non-Communicable Diseases

2020 ◽  
Vol 27 (12) ◽  
pp. 1955-1996 ◽  
Author(s):  
Antonio Speciale ◽  
Antonella Saija ◽  
Romina Bashllari ◽  
Maria Sofia Molonia ◽  
Claudia Muscarà ◽  
...  
Keyword(s):  
Human Health ◽  
Biological Activities ◽  
Wide Spectrum ◽  
Antioxidant Defenses ◽  
Noncommunicable Diseases ◽  
Protective Effects ◽  
Pathological Conditions ◽  
Chronic Pulmonary Diseases ◽  
Underlying Mechanisms

: Chronic Noncommunicable Diseases (NCDs), mostly represented by cardiovascular diseases, diabetes, chronic pulmonary diseases, cancers, and several chronic pathologies, are one of the main causes of morbidity and mortality, and are mainly related to the occurrence of metabolic risk factors. Anthocyanins (ACNs) possess a wide spectrum of biological activities, such as anti-inflammatory, antioxidant, cardioprotective and chemopreventive properties, which are able to promote human health. Although ACNs present an apparent low bioavailability, their metabolites may play an important role in the in vivo protective effects observed. : This article directly addresses the scientific evidences supporting that ACNs could be useful to protect human population against several NCDs not only acting as antioxidant but through their capability to modulate cell redox-dependent signaling. In particular, ACNs interact with the NF-κB and AP-1 signal transduction pathways, which respond to oxidative signals and mediate a proinflammatory effect, and the Nrf2/ARE pathway and its regulated cytoprotective proteins (GST, NQO, HO-1, etc.), involved in both cellular antioxidant defenses and elimination/inactivation of toxic compounds, so countering the alterations caused by conditions of chemical/oxidative stress. In addition, supposed crosstalks could contribute to explain the protective effects of ACNs in different pathological conditions characterized by an altered balance among these pathways. Thus, this review underlines the importance of specific nutritional molecules for human health and focuses on the molecular targets and the underlying mechanisms of ACNs against various diseases.

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