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Spray-freeze-dried Particles as Novel Delivery Systems for Vaccines and Active Pharmaceutical Ingredients
Published in S. Padma Ishwarya, Spray-Freeze-Drying of Foods and Bioproducts, 2022
Further, unlike freeze-drying, SFD particles seldom require an additional particle size reduction step. This aspect of SFD reduces processing-induced activity loss of APIs and facilitates the blending of dry powder aerosols with an additional mucoadhesive compound (Garmise, Staats, & Hickey, 2007). This feature of SFD is relevant as DPIs prepared by freeze-drying followed by milling have reduced efficacy due to the leakage of AI caused by stresses induced during the individual drying and milling operations. Consequently, substantial amount of AI are lost, which promotes the auto-adhesive properties of powder that lead to suboptimal dispersion of the AI (Desai et al., 2002). However, the instability of proteinaceous active ingredients during the atomization step limits the aerosolization behavior of SFD particles due to aggregation tendency. Loss of protein stability during SFD can be avoided by adding suitable stabilizing excipients to the feed formulation. The commonly used excipients are polyols (ex. mannitol), sugars (ex. lactose, trehalose), oligosaccharides (ex. inulin, β-cyclodextrin) and surfactants (ex. Tween 20, Tween 80) (Grasmeijer et al., 2013; Mensink et al., 2017; Depreter, Pilcer, & Amighi, 2013).
Biodegradability and Biocompatibility of Natural Polymers
Published in Amit Kumar Nayak, Md Saquib Hasnain, Dilipkumar Pal, Natural Polymers for Pharmaceutical Applications, 2019
Abul K. Mallik, Md Shahruzzaman, Md Sazedul Islam, Papia Haque, Mohammed Mizanur Rahman
On the other hand, usually active drugs are formulated into a suitable dosage form with the aid of some excipients and the excipients have many functions like lubricating, gelling, binding, suspending, bulking agent, flavoring, sweetening, etc. Excipients are very important in the preparation of medicines because they help to maintain the safety, efficacy, and constancy of active pharmaceutical constituents. They are the highest constituents of any pharmaceutical formulation originated from natural or synthetic sources. Applications of natural polymers as raw materials in the pharmaceutical industry play a vital role due to their biodegradability and nontoxicity. They also cost-effective and comparative abundance to synthetic polymers (Malafaya et al., 2007; Malviya et al., 2011). Moreover, natural resources are renewable and sustainable, which can offer a constant supply of raw material (Perepelkin, 2005). Polysaccharides and their derivatives are extensively applied in pharmaceutical preparations, and in various cases, their existence are very important help to release the drug in an appropriate rate. Pharmaceutical industries have been using naturally occurring polymers as excipients in various dosage forms (solid, liquid, semisolid, etc.) for their pharmaceutical formulations.
Excipients for Parenteral Use
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Sandeep Nema, Ronald J. Brendel
In addition to testing and specifications, regulatory bodies are also focusing their attention on excipient manufacturing processes. There have been major initiatives on the part of IPEC to improve the quality of additives resulting in a publication titled ‘Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients’.79 Excipients may be manufactured for the food, cosmetic, chemical, agriculture or pharmaceutical industry and the regulatory requirements for each industry are different. The purpose of this guide is to develop a quality system framework that may be used for excipient suppliers, which will be acceptable to the pharmaceutical industry and harmonize the US, Europe and Japan requirements.
Progress in spray-drying of protein pharmaceuticals: Literature analysis of trends in formulation and process attributes
Published in Drying Technology, 2021
Joana T. Pinto, Eva Faulhammer, Johanna Dieplinger, Michael Dekner, Christian Makert, Marco Nieder, Amrit Paudel
Functional excipients are pharmacologically inactive ingredients that play a crucial role in improving delivery, processability and stability of formulated drugs, ensuring pharmaceutical performance. Typically, diverse excipients are included when formulating the spray-dried proteins (see Table 1). Excipients can aid in interfacial stabilization during dehydration/drying steps, improve yield and processability of the spray-dried powders as well as enhance their dispersity and reconstitution. Our analysis considered the excipients used in the formulation of the feed solutions prior to spray-drying. We categorized our findings of the excipients into six chemical classes (Figure 4): saccharides (55%), amino acids (15%), surfactants (10%), salts and buffering agents (5%), excipient proteins (3%), and other molecules (12%).
Drug coated balloons and their role in bifurcation coronary angioplasty: appraisal of the current evidence and future directions
Published in Expert Review of Medical Devices, 2020
Sudhir Rathore, Shana Tehrani, Deiti Prvulovic, Mario Araya, Thierry Lefèvre, Adrian P Banning, Francesco Burzotta, Gianluca Rigatelli, Juan Luis Gutierrez-Chico, Klaus Bonaventura, Bernard Chevalier, Yoshihisa Kinoshita, Jozica Sikic, Fernando Alfonso, Yves Louvard, Goran Stankovic
The high-lipophilic property of Paclitaxel allows for passive absorption through cell membrane and sustained effect within the treated vessel wall [41]. On the other hand, Limus drugs such as Sirolimus and Zotarolimus, which are much less lipophilic than paclitaxel, have also shown efficacy in suppression of neointimal growth in a few animal models; however, to date, the data in humans are limited. DCBs require a quick, one to two-minute transfer of the drug load to the artery. With such a short time to interact with the target lesion, excipients or drug carriers can be used to enhance drug delivery and retention. Excipients are the key for enhancing drug solubility, drug transfer and drug uptake [31,37]. Comparison pharmacokinetics between different generation DCB and drug coating is shown in Table 2. Ideally, DCB should deliver the full drug dose to the target lesion, preferably limus-derivative drug, deploy full drug to the target lesion during angioplasty in <60 s, ensure mural drug uptake, and sustain drug release over the period of 4 weeks.
In vitro and in vivo evaluation of porous lactose/mannitol carriers for solubility enhancement of poorly water-soluble drugs
Published in Drying Technology, 2020
Niyanhan Jiang, Shanshan Wang, Zeneng Cheng, Wenjie Liu
Lactose and mannitol are the most commonly used pharmaceutical excipients, with their cost effectiveness, excellent physical/chemical stability, and water solubility.[11] A template-based production method has been developed in previous studies to create highly porous lactose or mannitol.[5,12] Lactose or mannitol as core material has high water solubility but poor ethanol solubility. When co-spray dried with ethanol-soluble food-grade acids or small molecular sugars as templates, the templates can be removed by an ethanol washing step.[13] The resultant template-free powder remains crystalline structure and generates high pore volume for drug loading. The construction of lactose or mannitol as porous carriers for controlled drug release has been reported.[5,14–17] Ebrahimi et al.[17] used an adsorption method, which refers to immerse the porous lactose materials into the drug solution to co-confine the drug into voids of the carrier. Excellent blend uniformity of acetaminophen with relative standard deviations of less than 3.5% was achieved. And dissolution of the deposited drug from the highly porous structure was facilitated due to enhanced penetration of the release medium into the matrix and increased contact area between the drug and the medium.