QbD Based Formulation Development and Optimisation of Ozenoxacin Topical Nano-Emulgel and Efficacy Evaluation Using Impetigo Mice Model
This study demonstrates the application of QbD methodology for the development and optimization of an effective topical nanoemulgel formulation for the treatment of Impetigo focusing on the selection of appropriate excipients, optimization of formulation and process variables, and characterization of critical quality attributes. BBD was used to study the effect of "% of oil, % of Smix and homogenization speed" on critical quality attributes "globule size and % entrapment efficiency" for the optimisation of Ozenoxacin Nano-emulsion. Ozenoxacin loaded nano-emulgel was characterized for "description, identification, pH, speci...
Source: AAPS PharmSciTech - April 22, 2024 Category: Drugs & Pharmacology Authors: Amarnath Reddy Ramireddy Dilip Kumar Behara Source Type: research
Fluconazole-Loaded Ibuprofen In Situ Gel-Based Oral Spray for Oropharyngeal Candidiasis Treatment
AAPS PharmSciTech. 2024 Apr 19;25(5):89. doi: 10.1208/s12249-024-02804-y.ABSTRACTOral candidiasis is a fungal infection affecting the oral mucous membrane, and this research specifically addresses on a localized treatment through fluconazole-loaded ibuprofen in situ gel-based oral spray. The low solubility of ibuprofen is advantageous for forming a gel when exposed to an aqueous phase. The 1% w/w fluconazole-loaded in situ gel oral sprays were developed utilizing various concentrations of ibuprofen in N-methyl pyrrolidone. The prepared solutions underwent evaluation for viscosity, surface tension, contact angle, water tole...
Source: AAPS PharmSciTech - April 19, 2024 Category: Drugs & Pharmacology Authors: Ei Mon Khaing Setthapong Senarat Kritamorn Jitrangsri Thawatchai Phaechamud Source Type: research
A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book
This study did a comprehensive analysis of the FDA's Purple Book database. Firstly, our research uncovered market trends and provided insights into biologics distributions. According to the investigation, although biotechnology has advanced and legislative shifts have made the approval process faster, there are still challenges to overcome, such as molecular instability and formulation design. Moreover, our research comprehensively analyzed biological formulations, pointing out significant strategies regarding administration routes, dosage forms, product packaging, and excipients. In conjunction with biologics, the widespr...
Source: AAPS PharmSciTech - April 18, 2024 Category: Drugs & Pharmacology Authors: Fuduan Chen Hao Zhong Ging Chan Defang Ouyang Source Type: research
Correction to: Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study
AAPS PharmSciTech. 2024 Apr 18;25(5):87. doi: 10.1208/s12249-024-02795-w.NO ABSTRACTPMID:38637409 | DOI:10.1208/s12249-024-02795-w (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - April 18, 2024 Category: Drugs & Pharmacology Authors: William W van Osdol Jasmina Novakovic Maxime Le Merdy Eleftheria Tsakalozou Priyanka Ghosh Jessica Spires Viera Lukacova Source Type: research
A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book
This study did a comprehensive analysis of the FDA's Purple Book database. Firstly, our research uncovered market trends and provided insights into biologics distributions. According to the investigation, although biotechnology has advanced and legislative shifts have made the approval process faster, there are still challenges to overcome, such as molecular instability and formulation design. Moreover, our research comprehensively analyzed biological formulations, pointing out significant strategies regarding administration routes, dosage forms, product packaging, and excipients. In conjunction with biologics, the widespr...
Source: AAPS PharmSciTech - April 18, 2024 Category: Drugs & Pharmacology Authors: Fuduan Chen Hao Zhong Ging Chan Defang Ouyang Source Type: research
Correction to: Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study
AAPS PharmSciTech. 2024 Apr 18;25(5):87. doi: 10.1208/s12249-024-02795-w.NO ABSTRACTPMID:38637409 | DOI:10.1208/s12249-024-02795-w (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - April 18, 2024 Category: Drugs & Pharmacology Authors: William W van Osdol Jasmina Novakovic Maxime Le Merdy Eleftheria Tsakalozou Priyanka Ghosh Jessica Spires Viera Lukacova Source Type: research
Novel Drug Delivery Approaches for the Localized Treatment of Cervical Cancer
AAPS PharmSciTech. 2024 Apr 11;25(4):85. doi: 10.1208/s12249-024-02801-1.ABSTRACTCervical cancer (CC) is the fourth leading cancer type in females globally. Being an ailment of the birth canal, primitive treatment strategies, including surgery, radiation, or laser therapy, bring along the risk of infertility, neonate mortality, premature parturition, etc. Systemic chemotherapy led to systemic toxicity. Therefore, delivering a smaller cargo of therapeutics to the local site is more beneficial in terms of efficacy as well as safety. Due to the regeneration of cervicovaginal mucus, conventional dosage forms come with the limi...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Ivy Saha Jitu Halder Tushar Kanti Rajwar Ritu Mahanty Deepak Pradhan Priyanka Dash Chandan Das Vineet Kumar Rai Biswakanth Kar Goutam Ghosh Goutam Rath Source Type: research
The Effect of Inflammatory Bowel Disease and Irritable Bowel Syndrome on Pravastatin Oral Bioavailability: In vivo and in silico evaluation using bottom-up wbPBPK modeling
AAPS PharmSciTech. 2024 Apr 11;25(4):86. doi: 10.1208/s12249-024-02803-z.ABSTRACTThe common disorders irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) can modify the drugs' pharmacokinetics via their induced pathophysiological changes. This work aimed to investigate the impact of these two diseases on pravastatin oral bioavailability. Rat models for IBS and IBD were used to experimentally test the effects of IBS and IBD on pravastatin pharmacokinetics. Then, the observations made in rats were extrapolated to humans using a mechanistic whole-body physiologically-based pharmacokinetic (wbPBPK) model. The r...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Motasem M Alsmadi Alla A Abudaqqa Nasir Idkaidek Nidal A Qinna Ahmad Al-Ghazawi Source Type: research
Natural Polymer-Based Nanogel for pH-Responsive Delivery of Sorafenib Tosylate in Hemangiosarcoma
This study is promising but challenging depending on the in vivo study. The nanogel was successfully prepared and evaluated for pH-responsive release. As hemangiosarcoma commonly occurs in dogs, this formulation helps to limit the difficulties with administration.PMID:38605211 | DOI:10.1208/s12249-024-02797-8 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Kiran K Mali Yogeshkumar N Gavhane Rita D Chakole Source Type: research
Multicomponent Amorphous Solid Forms of Telmisartan: Insights into Mechanochemical Activation and Physicochemical Attributes
AAPS PharmSciTech. 2024 Apr 11;25(4):84. doi: 10.1208/s12249-024-02799-6.ABSTRACTThe present work aims to explore the new solid forms of telmisartan (TEL) with alpha-ketoglutaric acid (KGA) and glutamic acid (GA) as potential coformers using mechanochemical approach and their role in augmentation in physicochemical parameters over pure crystalline TEL. Mechanochemical synthesis was performed using 1:1 stoichiometric ratio of TEL and the selected coformers in the presence of catalytic amount of ethanol for 1 h. The ground product was characterized by PXRD, DSC, and FTIR. The new solid forms were evaluated for apparent solub...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Jamshed Haneef Shakir Ali Source Type: research
Novel Drug Delivery Approaches for the Localized Treatment of Cervical Cancer
AAPS PharmSciTech. 2024 Apr 11;25(4):85. doi: 10.1208/s12249-024-02801-1.ABSTRACTCervical cancer (CC) is the fourth leading cancer type in females globally. Being an ailment of the birth canal, primitive treatment strategies, including surgery, radiation, or laser therapy, bring along the risk of infertility, neonate mortality, premature parturition, etc. Systemic chemotherapy led to systemic toxicity. Therefore, delivering a smaller cargo of therapeutics to the local site is more beneficial in terms of efficacy as well as safety. Due to the regeneration of cervicovaginal mucus, conventional dosage forms come with the limi...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Ivy Saha Jitu Halder Tushar Kanti Rajwar Ritu Mahanty Deepak Pradhan Priyanka Dash Chandan Das Vineet Kumar Rai Biswakanth Kar Goutam Ghosh Goutam Rath Source Type: research
The Effect of Inflammatory Bowel Disease and Irritable Bowel Syndrome on Pravastatin Oral Bioavailability: In vivo and in silico evaluation using bottom-up wbPBPK modeling
AAPS PharmSciTech. 2024 Apr 11;25(4):86. doi: 10.1208/s12249-024-02803-z.ABSTRACTThe common disorders irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) can modify the drugs' pharmacokinetics via their induced pathophysiological changes. This work aimed to investigate the impact of these two diseases on pravastatin oral bioavailability. Rat models for IBS and IBD were used to experimentally test the effects of IBS and IBD on pravastatin pharmacokinetics. Then, the observations made in rats were extrapolated to humans using a mechanistic whole-body physiologically-based pharmacokinetic (wbPBPK) model. The r...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Motasem M Alsmadi Alla A Abudaqqa Nasir Idkaidek Nidal A Qinna Ahmad Al-Ghazawi Source Type: research
Natural Polymer-Based Nanogel for pH-Responsive Delivery of Sorafenib Tosylate in Hemangiosarcoma
This study is promising but challenging depending on the in vivo study. The nanogel was successfully prepared and evaluated for pH-responsive release. As hemangiosarcoma commonly occurs in dogs, this formulation helps to limit the difficulties with administration.PMID:38605211 | DOI:10.1208/s12249-024-02797-8 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Kiran K Mali Yogeshkumar N Gavhane Rita D Chakole Source Type: research
Multicomponent Amorphous Solid Forms of Telmisartan: Insights into Mechanochemical Activation and Physicochemical Attributes
AAPS PharmSciTech. 2024 Apr 11;25(4):84. doi: 10.1208/s12249-024-02799-6.ABSTRACTThe present work aims to explore the new solid forms of telmisartan (TEL) with alpha-ketoglutaric acid (KGA) and glutamic acid (GA) as potential coformers using mechanochemical approach and their role in augmentation in physicochemical parameters over pure crystalline TEL. Mechanochemical synthesis was performed using 1:1 stoichiometric ratio of TEL and the selected coformers in the presence of catalytic amount of ethanol for 1 h. The ground product was characterized by PXRD, DSC, and FTIR. The new solid forms were evaluated for apparent solub...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Jamshed Haneef Shakir Ali Source Type: research
Novel Drug Delivery Approaches for the Localized Treatment of Cervical Cancer
AAPS PharmSciTech. 2024 Apr 11;25(4):85. doi: 10.1208/s12249-024-02801-1.ABSTRACTCervical cancer (CC) is the fourth leading cancer type in females globally. Being an ailment of the birth canal, primitive treatment strategies, including surgery, radiation, or laser therapy, bring along the risk of infertility, neonate mortality, premature parturition, etc. Systemic chemotherapy led to systemic toxicity. Therefore, delivering a smaller cargo of therapeutics to the local site is more beneficial in terms of efficacy as well as safety. Due to the regeneration of cervicovaginal mucus, conventional dosage forms come with the limi...
Source: AAPS PharmSciTech - April 11, 2024 Category: Drugs & Pharmacology Authors: Ivy Saha Jitu Halder Tushar Kanti Rajwar Ritu Mahanty Deepak Pradhan Priyanka Dash Chandan Das Vineet Kumar Rai Biswakanth Kar Goutam Ghosh Goutam Rath Source Type: research
