Correction: Preparation of Self-microemulsion Solids of Kaempferia galanga (L.) Volatile Oil and Its Effect on Rats with Gastric Ulcer
AAPS PharmSciTech. 2023 Dec 13;24(8):257. doi: 10.1208/s12249-023-02719-0.NO ABSTRACTPMID:38093162 | DOI:10.1208/s12249-023-02719-0 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 13, 2023 Category: Drugs & Pharmacology Authors: Dongrong Liu Ruiping Liu Zebin Zhuang Bijin Yao Chuyue Qin Fangli Ma Jun Shi Source Type: research

Correction: In Vitro and In Vivo Evaluation of Metformin Hydrochloride Hydrogels Developed with Experimental Design in the Treatment of Burns
AAPS PharmSciTech. 2023 Dec 12;24(8):256. doi: 10.1208/s12249-023-02715-4.NO ABSTRACTPMID:38087158 | DOI:10.1208/s12249-023-02715-4 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 12, 2023 Category: Drugs & Pharmacology Authors: Emine Dilek Ozyilmaz Rojhat Celikkaya Tansel Comoglu Hulda Rifat Ozakpinar Kemal Behzatoglu Source Type: research

Correction: In Vitro and In Vivo Evaluation of Metformin Hydrochloride Hydrogels Developed with Experimental Design in the Treatment of Burns
AAPS PharmSciTech. 2023 Dec 12;24(8):256. doi: 10.1208/s12249-023-02715-4.NO ABSTRACTPMID:38087158 | DOI:10.1208/s12249-023-02715-4 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - December 12, 2023 Category: Drugs & Pharmacology Authors: Emine Dilek Ozyilmaz Rojhat Celikkaya Tansel Comoglu Hulda Rifat Ozakpinar Kemal Behzatoglu Source Type: research

Discriminative Dissolution Method Development Through an aQbD Approach
AAPS PharmSciTech. 2023 Dec 8;24(8):255. doi: 10.1208/s12249-023-02692-8.ABSTRACTUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method...
Source: AAPS PharmSciTech - December 8, 2023 Category: Drugs & Pharmacology Authors: Hongbo Chen Rui Wang John-David McElderry Source Type: research

Discriminative Dissolution Method Development Through an aQbD Approach
AAPS PharmSciTech. 2023 Dec 8;24(8):255. doi: 10.1208/s12249-023-02692-8.ABSTRACTUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method...
Source: AAPS PharmSciTech - December 8, 2023 Category: Drugs & Pharmacology Authors: Hongbo Chen Rui Wang John-David McElderry Source Type: research

Discriminative Dissolution Method Development Through an aQbD Approach
AAPS PharmSciTech. 2023 Dec 8;24(8):255. doi: 10.1208/s12249-023-02692-8.ABSTRACTUsing a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of discrimination power through an analytical Quality by Design (aQbD) approach. In the first stage, an optimal dissolution method was achieved by determining the method operable design region (MODR) through a design of experiment study of the high-risk method...
Source: AAPS PharmSciTech - December 8, 2023 Category: Drugs & Pharmacology Authors: Hongbo Chen Rui Wang John-David McElderry Source Type: research

Amorphization of Low Soluble Drug with Amino Acids to Improve Its Therapeutic Efficacy: a State-of-Art-Review
AAPS PharmSciTech. 2023 Dec 7;24(8):253. doi: 10.1208/s12249-023-02709-2.ABSTRACTLow aqueous solubility of drug candidates is an ongoing challenge and pharmaceutical manufacturers pay close attention to amorphization (AMORP) technology to improve the solubility of drugs that dissolve poorly. Amorphous drug typically exhibits much higher apparent solubility than their crystalline form due to high energy state that enable them to produce a supersaturated state in the gastrointestinal tract and thereby improve bioavailability. The stability and augmented solubility in co-amorphous (COA) formulations is influenced by molecular...
Source: AAPS PharmSciTech - December 7, 2023 Category: Drugs & Pharmacology Authors: Devesh U Kapoor Sudarshan Singh Pratishtha Sharma Bhupendra G Prajapati Source Type: research

Machine Learning-Enabled NIR Spectroscopy. Part 3: Hyperparameter by Design (HyD) Based ANN-MLP Optimization, Model Generalizability, and Model Transferability
In this study, the hyperparameter optimization for the Artificial Neural Network Multilayer Perceptron (ANN-MLP) was investigated using open-source data. The design of experiments (DoE) approach in combination with target drift prediction and statistical process control (SPC) was employed to achieve this objective. First, pre-screening and optimization DoEs were conducted on lab-scale data, serving as internal validation data, to identify the design space and control space. The regression performance metrics were carefully monitored to ensure the right set of hyperparameters was selected, optimizing the modelling time and ...
Source: AAPS PharmSciTech - December 7, 2023 Category: Drugs & Pharmacology Authors: Hussain Ali Prakash Muthudoss Chirag Chauhan Ilango Kaliappan Dinesh Kumar Amrit Paudel Gobi Ramasamy Source Type: research

Amorphization of Low Soluble Drug with Amino Acids to Improve Its Therapeutic Efficacy: a State-of-Art-Review
AAPS PharmSciTech. 2023 Dec 7;24(8):253. doi: 10.1208/s12249-023-02709-2.ABSTRACTLow aqueous solubility of drug candidates is an ongoing challenge and pharmaceutical manufacturers pay close attention to amorphization (AMORP) technology to improve the solubility of drugs that dissolve poorly. Amorphous drug typically exhibits much higher apparent solubility than their crystalline form due to high energy state that enable them to produce a supersaturated state in the gastrointestinal tract and thereby improve bioavailability. The stability and augmented solubility in co-amorphous (COA) formulations is influenced by molecular...
Source: AAPS PharmSciTech - December 7, 2023 Category: Drugs & Pharmacology Authors: Devesh U Kapoor Sudarshan Singh Pratishtha Sharma Bhupendra G Prajapati Source Type: research

Machine Learning-Enabled NIR Spectroscopy. Part 3: Hyperparameter by Design (HyD) Based ANN-MLP Optimization, Model Generalizability, and Model Transferability
In this study, the hyperparameter optimization for the Artificial Neural Network Multilayer Perceptron (ANN-MLP) was investigated using open-source data. The design of experiments (DoE) approach in combination with target drift prediction and statistical process control (SPC) was employed to achieve this objective. First, pre-screening and optimization DoEs were conducted on lab-scale data, serving as internal validation data, to identify the design space and control space. The regression performance metrics were carefully monitored to ensure the right set of hyperparameters was selected, optimizing the modelling time and ...
Source: AAPS PharmSciTech - December 7, 2023 Category: Drugs & Pharmacology Authors: Hussain Ali Prakash Muthudoss Chirag Chauhan Ilango Kaliappan Dinesh Kumar Amrit Paudel Gobi Ramasamy Source Type: research

Nano vs Resistant Tuberculosis: Taking the Lung Route
AAPS PharmSciTech. 2023 Dec 4;24(8):252. doi: 10.1208/s12249-023-02708-3.ABSTRACTTuberculosis (TB) is among the top 10 infectious diseases worldwide. It is categorized among the leading killer diseases that are the reason for the death of millions of people globally. Although a standardized treatment regimen is available, non-adherence to treatment has increased multi-drug resistance (MDR) and extensive drug-resistant (XDR) TB development. Another challenge is targeting the death of TB reservoirs in the alveoli via conventional treatment. TB Drug resistance may emerge as a futuristic restraint of TB with the scarcity of ef...
Source: AAPS PharmSciTech - December 4, 2023 Category: Drugs & Pharmacology Authors: Deepika Sharma None Pooja Sunita Nirban Smriti Ojha Tarun Kumar Neha Jain Najwa Mohamad Pradeep Kumar Manisha Pandey Source Type: research

Nano vs Resistant Tuberculosis: Taking the Lung Route
AAPS PharmSciTech. 2023 Dec 4;24(8):252. doi: 10.1208/s12249-023-02708-3.ABSTRACTTuberculosis (TB) is among the top 10 infectious diseases worldwide. It is categorized among the leading killer diseases that are the reason for the death of millions of people globally. Although a standardized treatment regimen is available, non-adherence to treatment has increased multi-drug resistance (MDR) and extensive drug-resistant (XDR) TB development. Another challenge is targeting the death of TB reservoirs in the alveoli via conventional treatment. TB Drug resistance may emerge as a futuristic restraint of TB with the scarcity of ef...
Source: AAPS PharmSciTech - December 4, 2023 Category: Drugs & Pharmacology Authors: Deepika Sharma None Pooja Sunita Nirban Smriti Ojha Tarun Kumar Neha Jain Najwa Mohamad Pradeep Kumar Manisha Pandey Source Type: research

Nano vs Resistant Tuberculosis: Taking the Lung Route
AAPS PharmSciTech. 2023 Dec 4;24(8):252. doi: 10.1208/s12249-023-02708-3.ABSTRACTTuberculosis (TB) is among the top 10 infectious diseases worldwide. It is categorized among the leading killer diseases that are the reason for the death of millions of people globally. Although a standardized treatment regimen is available, non-adherence to treatment has increased multi-drug resistance (MDR) and extensive drug-resistant (XDR) TB development. Another challenge is targeting the death of TB reservoirs in the alveoli via conventional treatment. TB Drug resistance may emerge as a futuristic restraint of TB with the scarcity of ef...
Source: AAPS PharmSciTech - December 4, 2023 Category: Drugs & Pharmacology Authors: Deepika Sharma None Pooja Sunita Nirban Smriti Ojha Tarun Kumar Neha Jain Najwa Mohamad Pradeep Kumar Manisha Pandey Source Type: research

Correction: Investigations on Compaction Behavior of Kollidon ®SR-Based Multi-component Directly Compressed Tablets for Preparation of Controlled Release Diclofenac Sodium
AAPS PharmSciTech. 2023 Nov 30;24(8):249. doi: 10.1208/s12249-023-02707-4.NO ABSTRACTPMID:38036726 | DOI:10.1208/s12249-023-02707-4 (Source: AAPS PharmSciTech)
Source: AAPS PharmSciTech - November 30, 2023 Category: Drugs & Pharmacology Authors: Wasfy M Obeidat Ishraq K Lahlouh Shadi F Gharaibeh Source Type: research

A Bayesian Approach to Kinetic Modeling of Accelerated Stability Studies and Shelf Life Determination
AAPS PharmSciTech. 2023 Nov 30;24(8):250. doi: 10.1208/s12249-023-02695-5.ABSTRACTKinetic modeling of accelerated stability data serves an important purpose in the development of pharmaceutical products, providing support for shelf life claims and expediting the path to clinical implementation. In this context, a Bayesian kinetic modeling framework is considered, accommodating different types of nonlinear kinetics with temperature and humidity dependent rates of degradation and accounting for the humidity conditions within the packaging to predict the shelf life. In comparison to kinetic modeling based on nonlinear least-s...
Source: AAPS PharmSciTech - November 30, 2023 Category: Drugs & Pharmacology Authors: Joris Chau Stan Altan Anneleen Burggraeve Hans Coppenolle Yimer Wasihun Kifle Hana Prokopcova Timothy Van Daele Hans Sterckx Source Type: research