Metformin(Met)is a drug developed for the treatment of patients with typeⅡ diabetes.Recently,Met estimation in pharmaceutical formulations and human fluids has gained a growing interest.To extend requisite data that ...Metformin(Met)is a drug developed for the treatment of patients with typeⅡ diabetes.Recently,Met estimation in pharmaceutical formulations and human fluids has gained a growing interest.To extend requisite data that can be used to assessment of Met quantitatively based on charge-transfer(CT)complexation,the present study describes the synthesis and characterization of CT complexes that formed between drug Met and the organicπ-acceptors picric acid(PA),chloranilic acid(CLA),chloranil(CHL),7,7',8,8'-tetracyanoquinodimethane(TCNQ),and dichlorodicyanobenzoquinone(DDQ).The properties of the formed CT complexes were investigated by elemental,spectral(UV-visible,IR,and Raman spectroscopies),thermal(TG)and morphological(SEM)studies.IR results indicated that the complexation of Met with either PA or CLA acceptors occurs through proton transfer interaction,whereas its complexation with CHL,TCNQ,or DDQ acceptors occurs through n→π*interaction.展开更多
Low-level laser therapy (LLLT) or cold laser has been used in medicine for several decades. However, the method utilizes a direct contact of the light beam with a patient. Further research resulted in development of a...Low-level laser therapy (LLLT) or cold laser has been used in medicine for several decades. However, the method utilizes a direct contact of the light beam with a patient. Further research resulted in development of another method that enables remote transmission of the pharmacological properties of a medicament into a human body with the application of low-level laser radiation as the light source. 18 patients with different viral diseases were treated with the antiviral drugs placed into the field formed by the unexplained properties of low-level laser radiation of the “device for transfer of the pharmacological properties of a drug into the patient’s body”. This resulted in improvement of the patient’s condition, the absence of side effects and adverse reactions when using drugs in the proposed device and shortened therapy period for patients with chronic hepatitis C infection and Covid-19 patients. The long-term follow-up of the patients with chronic hepatitis B infection showed that hepatitis B virus remained at low replication levels under the influence of the therapy, which made it possible to avoid such formidable complications of the disease as cirrhosis of the liver and liver cancer.展开更多
Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured...Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.展开更多
Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poise...Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poised to revolutionize therapeutics. This paper examines the complexities of ADC production, emphasizing the importance of process characterization and the pivotal role of supply chain characteristics, safety requirements, and Contract Manufacturing Organizations (CMOs) with proficiency. The swift transition of antibody-drug conjugate (ADC) programs from early to advanced clinical stages underscores the urgency for quick and efficient commercial launch preparation. This article delves into strategies to hasten commercial readiness, supply chain strategy, the significance of partnering with adept contract development and manufacturing organizations (CDMOs), and the challenges of ADC production.展开更多
基金Study and Research,Taif University,Saudi Arabia under project Grants No.5545-438-1
文摘Metformin(Met)is a drug developed for the treatment of patients with typeⅡ diabetes.Recently,Met estimation in pharmaceutical formulations and human fluids has gained a growing interest.To extend requisite data that can be used to assessment of Met quantitatively based on charge-transfer(CT)complexation,the present study describes the synthesis and characterization of CT complexes that formed between drug Met and the organicπ-acceptors picric acid(PA),chloranilic acid(CLA),chloranil(CHL),7,7',8,8'-tetracyanoquinodimethane(TCNQ),and dichlorodicyanobenzoquinone(DDQ).The properties of the formed CT complexes were investigated by elemental,spectral(UV-visible,IR,and Raman spectroscopies),thermal(TG)and morphological(SEM)studies.IR results indicated that the complexation of Met with either PA or CLA acceptors occurs through proton transfer interaction,whereas its complexation with CHL,TCNQ,or DDQ acceptors occurs through n→π*interaction.
文摘Low-level laser therapy (LLLT) or cold laser has been used in medicine for several decades. However, the method utilizes a direct contact of the light beam with a patient. Further research resulted in development of another method that enables remote transmission of the pharmacological properties of a medicament into a human body with the application of low-level laser radiation as the light source. 18 patients with different viral diseases were treated with the antiviral drugs placed into the field formed by the unexplained properties of low-level laser radiation of the “device for transfer of the pharmacological properties of a drug into the patient’s body”. This resulted in improvement of the patient’s condition, the absence of side effects and adverse reactions when using drugs in the proposed device and shortened therapy period for patients with chronic hepatitis C infection and Covid-19 patients. The long-term follow-up of the patients with chronic hepatitis B infection showed that hepatitis B virus remained at low replication levels under the influence of the therapy, which made it possible to avoid such formidable complications of the disease as cirrhosis of the liver and liver cancer.
文摘Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.
文摘Antibody-drug conjugates (ADCs) are pioneering biologics that merge antibodies’ specificity with small molecules’ potency. With a handful of FDA-approved ADCs in the market and many under development, ADCs are poised to revolutionize therapeutics. This paper examines the complexities of ADC production, emphasizing the importance of process characterization and the pivotal role of supply chain characteristics, safety requirements, and Contract Manufacturing Organizations (CMOs) with proficiency. The swift transition of antibody-drug conjugate (ADC) programs from early to advanced clinical stages underscores the urgency for quick and efficient commercial launch preparation. This article delves into strategies to hasten commercial readiness, supply chain strategy, the significance of partnering with adept contract development and manufacturing organizations (CDMOs), and the challenges of ADC production.
