R17. Solid Crystal Suspensions of Carbamazepine using Hot-melt Extrusion: A Solubility Enhancement Approach

Corresponding author (Pharmaceutics and Drug delivery): Sagar Narala, [email protected]://egrove.olemiss.edu/pharm_annual_posters/1016/thumbnail.jp

Polymeric Micelles for Breast Cancer Therapy: Recent Updates, Clinical Translation and Regulatory Considerations

With the growing burden of cancer, parallel advancements in anticancer nanotechnological solutions have been witnessed. Among the different types of cancers, breast cancer accounts for approximately 25% and leads to 15% of deaths. Nanomedicine and its allied fields of material science have revolutionized the science of medicine in the 21st century. Novel treatments have paved the way for improved drug delivery systems that have better efficacy and reduced adverse effects. A variety of nanoformulations using lipids, polymers, inorganic, and peptide-based nanomedicines with various functionalities are being synthesized. Thus, elaborate knowledge of these intelligent nanomedicines for highly promising drug delivery systems is of prime importance. Polymeric micelles (PMs) are generally easy to prepare with good solubilization properties; hence, they appear to be an attractive alternative over the other nanosystems. Although an overall perspective of PM systems has been presented in recent reviews, a brief discussion has been provided on PMs for breast cancer. This review provides a discussion of the state-of-the-art PMs together with the most recent advances in this field. Furthermore, special emphasis is placed on regulatory guidelines, clinical translation potential, and future aspects of the use of PMs in breast cancer treatment. The recent developments in micelle formulations look promising, with regulatory guidelines that are now more clearly defined; hence, we anticipate early clinical translation in the near future

Coupling FDM 3D Printing with Hot-Melt Extrusion to Produce Hypertensive Dual Therapy Fixed Dose Combination Tablet

Presenter: Abdullah Alzahranihttps://egrove.olemiss.edu/pharm_annual_posters_2021/1002/thumbnail.jp

Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects

Among various drug administration routes, oral drug delivery is preferred and is considered patient-friendly; hence, most of the marketed drugs are available as conventional tablets or capsules. In such cases, the administration of drugs with or without food has tremendous importance on the bioavailability of the drugs. The presence of food may increase (positive effect) or decrease (negative effect) the bioavailability of the drug. Such a positive or negative effect is undesirable since it makes dosage estimation difficult in several diseases. This may lead to an increased propensity for adverse effects of drugs when a positive food effect is perceived. However, a negative food effect may lead to therapeutic insufficiency for patients suffering from life-threatening disorders. This review emphasizes the causes of food effects, formulation strategies to overcome the fast-fed variability, and the regulatory aspects of drugs with food effects, which may open new avenues for researchers to design products that may help to eliminate fast-fed variability

Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles

Solid lipid nanoparticles (SLNs) are an alternate carrier system to liposomes, polymeric nanoparticles, and inorganic carriers. SLNs have attracted increasing attention in recent years for delivering drugs, nucleic acids, proteins, peptides, nutraceuticals, and cosmetics. These nanocarriers have attracted industrial attention due to their ease of preparation, physicochemical stability, and scalability. These characteristics make SLNs attractive for manufacture on a large scale. Currently, several products with SLNs are in clinical trials, and there is a high possibility that SLN carriers will quickly increase their presence in the market. A large-scale manufacturing unit is required for commercial applications to prepare enough formulations for clinical studies. Furthermore, continuous processing is becoming more popular in the pharmaceutical sector to reduce product batch-to-batch differences. This review paper discusses some conventional methods and the rationale for large-scale production. It further covers recent progress in scale-up methods for the synthesis of SLNs, including high-pressure homogenization (HPH), hot melt extrusion coupled with HPH, microchannels, nanoprecipitation using static mixers, and microemulsion-based methods. These scale-up technologies enable the possibility of commercialization of SLNs. Furthermore, ongoing studies indicate that these technologies will eventually reach the pharmaceutical market

Progress on Thin Film Freezing Technology for Dry Powder Inhalation Formulations

The surface drying process is an important technology in the pharmaceutical, biomedical, and food industries. The final stage of formulation development (i.e., the drying process) faces several challenges, and overall mastering depends on the end step. The advent of new emerging technologies paved the way for commercialization. Thin film freezing (TFF) is a new emerging freeze-drying technique available for various treatment modalities in drug delivery. TFF has now been used for the commercialization of pharmaceuticals, food, and biopharmaceutical products. The present review highlights the fundamentals of TFF along with modulated techniques used for drying pharmaceuticals and biopharmaceuticals. Furthermore, we have covered various therapeutic applications of TFF technology in the development of nanoformulations, dry powder for inhalations and vaccines. TFF holds promise in delivering therapeutics for lung diseases such as fungal infection, bacterial infection, lung dysfunction, and pneumonia

Predictive Performance Evaluation of Different Neural Networks Using Stock Prices

Forecasting stock market prices has been a challenging task due to its volatile nature and nonlinearity. Recently, artificial neural networks (ANNs) have become popular in solving a variety of scientific and financial problems including stock market price forecasting. ANNs have the ability to capture the underlying nonlinearity and complex relationship between the dependent and independent variables. This paper aims to compare the performance of various neural networks including Feed Forward Neural Networks (FNN), Vanilla Recurrent Neural Network (RNN), and Long Short-Term Memory (LSTM) neural networks by forecasting stock market prices of three different companies. Empirical results show that the LSTM neural network performed well in forecasting stock market prices compared to both vanilla RNN and FNN

Novel Applications of Hot Melt Extrusion for Developing Oral Solid Dosage Forms with Improved Solubility, Permeability, and Stability

In today\u27s world, with an increasing patient population, the demand for pharmaceutical medications is increasing enormously. However, pharmaceutical industries are continuously failing to meet market and patient populations\u27 demands. Poor solubility of the drug substances is the major roadblock affecting the pharmaceutical industries in meeting the market demand and revenue. Around 70-80% of the new chemical entities within the developmental pipeline are claimed to be poorly soluble, affecting the oral bioavailability. Improving the solubility of drug substances by preserving their stability and physiological action is the primary prerequisite for developmental scientists. The underdeveloped manufacturing process with various limitations is another major drawback affecting the health care industries in getting the products into the market. The conventional manufacturing techniques involve various unit operations, which require huge capital and human resources. In recent years the regulatory agencies and pharmaceutical industries are transforming their interest from batch manufacturing to continuous manufacturing. Continuous manufacturing involves continuously feeding material at one end of the equipment train and collection of finished products at the other. The quality of the products can be continuously monitored and controlled by employing process analytical technology (PAT) tools throughout the manufacturing process, which is an added advantage of a continuous manufacturing process. The hot melt extrusion process can also be suitable for twin-screw granulation by slightly modifying the extruder barrel. Depending on the physical state of the binder or the formulation components within the extruder barrel, the twin-screw granulation process is divided into twin-screw melt granulation, twin screw wet granulation, and twin-screw dry granulation. In recent years hot melt extrusion process has been most widely investigated for continuous manufacturing and for improving the solubility of poorly water-soluble drug substances by various formulation approaches. This dissertation mainly focuses on developing solid oral dosage forms with improved solubility, permeability, and stability of drug substances by employing a single-step continuous manufacturing process, i.e., either hot melt extrusion or twin-screw granulation

Improved Dissolution Rate and Intestinal Absorption of Fexofenadine Hydrochloride by the Preparation of Solid Dispersions: In Vitro and In Situ Evaluation

The objective of this study was to enhance dissolution and permeation of a low soluble, absorbable fexofenadine hydrochloride (FFH) by preparing solid dispersions using polyethylene glycol 20,000 (PEG 20,000) and poloxamer 188 as carriers. The phase solubility measurement for the supplied FFH revealed a linear increase in the solubility of fexofenadine with increasing carrier concentration in water (1.45 mg/mL to 11.78 mg/mL with 0% w/v to 30% w/v PEG 20,000; 1.45 mg/mL to 12.27 mg/mL with 0% w/v to 30% w/v poloxamer 188). To select the appropriate drug carrier concentration, a series of solid dispersions were prepared in the drug carrier weight ratios of 1:1, 1:2 and 1:4 by fusion method. The solid dispersions composed of drug carrier at 1:4 weight ratio showed highest dissolution with the time required for the release of 50% of the drug <15 min compared to the supplied FFH (>120 min). The intestinal absorption study presented a significant improvement in the absorption of drug from the solid dispersions composed of poloxamer 188 than PEG 20,000. In summary, the solid dispersions of FFH prepared using PEG 20,000 and poloxamer 188 demonstrated improved dissolution and absorption than supplied FFH and could be used to improve the oral bioavailability of fexofenadine

Polymeric micelles for breast cancer therapy: recent updates, clinical translation and regulatory considerations

With the growing burden of cancer, parallel advancements in anticancer nanotechnological solutions have been witnessed. Among the different types of cancers, breast cancer accounts for approximately 25% and leads to 15% of deaths. Nanomedicine and its allied fields of material science have revolutionized the science of medicine in the 21st century. Novel treatments have paved the way for improved drug delivery systems that have better efficacy and reduced adverse effects. A variety of nanoformulations using lipids, polymers, inorganic, and peptide-based nanomedicines with various functionalities are being synthesized. Thus, elaborate knowledge of these intelligent nanomedicines for highly promising drug delivery systems is of prime importance. Polymeric micelles (PMs) are generally easy to prepare with good solubilization properties; hence, they appear to be an attractive alternative over the other nanosystems. Although an overall perspective of PM systems has been presented in recent reviews, a brief discussion has been provided on PMs for breast cancer. This review provides a discussion of the state-of-the-art PMs together with the most recent advances in this field. Furthermore, special emphasis is placed on regulatory guidelines, clinical translation potential, and future aspects of the use of PMs in breast cancer treatment. The recent developments in micelle formulations look promising, with regulatory guidelines that are now more clearly defined; hence, we anticipate early clinical translation in the near future