Applications of lipid-based nanocarriers for parenteral drug delivery

This review describes the use of Lipid-based Nanocarriers (LNCs) for the parenteral delivery of pharmaceutical actives. Firstly, the two generation of LNCs such as ‘‘solid lipid nanoparticles’’ (SLNs) and ‘‘nanostructured lipid carriers’’ (NLCs) are explained in term of preparation, characterization and stability. Although the use of LNCs through parenteral administration has shown many benefits, their use is limited by opsonization, an immune process that causes their short half-life (3-5 min). Therefore, many strategies are discussed to realize “stealth” systems suitable for parenteral administration. Successfully, the requirements and applications of parenteral lipid nanoparticles are reviewed for the delivery of natural compounds, synthetic drugs and genetic materials. In the last period, the latter application has been a remarkable interest due to the numerous benefits of mRNA vaccines to fight the Covid-19 pandemic.

Recommendations of scientifically sound and appropriate sampling plans for parenteral drug products

This paper gives recommendations for defining sampling plans/sizes that are statistically justified or based on published guidance for typical parenteral drug products Simple tables based on the ANSI/ASQ Z1.4 acceptance sample plans or other published guidance have been collated to aid organisations in selection of appropriate sample sizes/plans for routine drug product manufacture. Key Words: USP <1790>, visual inspection, AQL, power, sample size

A Review on Nanoparticles Drug Delivery System

The method or process of delivering a pharmaceutical ingredient to create a therapeutic effect in people or animals is referred to as drug delivery. Nasal and pulmonary routes of medication administration are becoming increasingly important in the treatment of human illnesses. These methods, especially for peptide and protein therapies, provide potential alternatives to parenteral drug administration. Several medication delivery methods have been developed for this purpose and are being tested for nasal and pulmonary delivery. Chitosan, Alginate, vanilline oxalate, zinc oxalate, cellulose, polymeric micelles, Gliadin, and phospholipid are examples of these. Multidrug resistance, a key issue in chemotherapy, can be reversed with these nanoparticles. Surgery, chemotherapy, immunotherapy, and radiation are all well-established treatments used in cancer treatment. A nanoparticle has emerged as a potential method for the targeted delivery of medicines used to treat certain illnesses. Keywords: Nasal Drug Delivery, Pulmonary Drug Delivery, Nanoparticles

Manufacturing of Liposomes: A Direct Comparison of Extrusion and Microfluidics Protocols

Liposomal formulations are frequently used for oral, topical, or parenteral drug administration. However, liposome manufacturing and industrial scale-up remains a challenge, in particular if it comes to the preparation of liposome populations with a homogenous size distribution. Therefore, extrusion through filter membranes with defined pore size is traditionally used during the preparation of small unilamellar liposomes. Microfluidics is considered to be an alternative manufacturing method. Lipids, solvents and excipients are thereby passively mixed using a microfluidics device. While the microfluidic approach is highly scalable, most of the traditional liposome preparation protocols rely on extrusion. It was therefore the aim of the present study to compare liposomal formulations with identical composition, which were prepared using either extrusion or microfluidics protocols. Liposomal formulations produced by both methods were analyzed using dynamic light scattering (DLS) to compare size, polydispersity, and ζ-potential. Our results indicate significant differences between liposomal preparations obtained using the two manufacturing methods. We conclude that the two preparation methods should not be used interchangeably.<br>

Manufacturing of Liposomes: A Direct Comparison of Extrusion and Microfluidics Protocols

Liposomal formulations are frequently used for oral, topical, or parenteral drug administration. However, liposome manufacturing and industrial scale-up remains a challenge, in particular if it comes to the preparation of liposome populations with a homogenous size distribution. Therefore, extrusion through filter membranes with defined pore size is traditionally used during the preparation of small unilamellar liposomes. Microfluidics is considered to be an alternative manufacturing method. Lipids, solvents and excipients are thereby passively mixed using a microfluidics device. While the microfluidic approach is highly scalable, most of the traditional liposome preparation protocols rely on extrusion. It was therefore the aim of the present study to compare liposomal formulations with identical composition, which were prepared using either extrusion or microfluidics protocols. Liposomal formulations produced by both methods were analyzed using dynamic light scattering (DLS) to compare size, polydispersity, and ζ-potential. Our results indicate significant differences between liposomal preparations obtained using the two manufacturing methods. We conclude that the two preparation methods should not be used interchangeably.<br>

Nicolau Syndrome Following Intralesional Sclerotherapy: A Dreaded Complication of a Simple Office Procedure

Introduction: Nicolau syndrome is an iatrogenic dreaded adverse skin reaction leading to ischemic necrosis of skin and underlying tissue after parenteral drug injection. The etiopathogenesis is poorly understood. However, inflammation, reflex vasospasm, and thrombo-embolic occlusion of blood vessels, including arterioles and arteries, are suggested as the cause of ischemia. Case Presentation: We report a 12-year-old girl who developed Nicolau syndrome after a simple office procedure of intralesional sclera therapy with sodium tetradecyl sulfate for a apyogenic granuloma on her right index finger. Three days later, she reported complaints of excruciatingly painful swelling with bluish discoloration of the right hand involving the palm, entire index, middle, and ring fingers, and distal part of the little finger. Nicolau syndrome was documented after intramuscular injections of drugs. Nevertheless, there are very few reports of Nicolau syndrome following post intralesional sclerotherapy. Conclusions: Sclerotherapy is a simple office procedure routinely performed by health care professionals (e.g., dermatologists and surgeons), and awareness about its dreaded entity is key. Stringent precautions and prompt management can prevent unfavorable complications. Additionally, prudent patient selection and detailed counseling with explicit informed consent regarding Nicolau syndrome are imperative while planning any parenteral drug injection or intralesional sclerotherapy to avoid litigation.