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Formulation of Protein- and Peptide-Based Parenteral Products
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Gaozhong Zhu, Pierre O. Souillac
Proteins are amphiphilic polyelectrolytes, so they tend to adsorb at liquid–solid, liquid–gas, and liquid–liquid interfaces. When adsorption of proteins occurs, the molecules exchange their interactions with the solvent and other solutes for interactions with the surface. Two mechanisms are primarily responsible for protein adsorption. One mechanism is charge–charge or electrostatic interaction. For example, salmon calcitonin, as a positively charged protein, strongly binds to the negative potential of a glass surface through electrostatic interaction (17). The other mechanism is hydrophobic interaction. One example is bovine serum albumin, which near its pI has shown the highest affinity to the hydrophobic surface of polystyrene through hydrophobic interactions (18). Other interactions, including charge–dipole, dipole–dipole, and van der Waals forces, may also contribute to the adsorption.
Engineering Stable Spray-Dried Biologic Powder for Inhalation
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Nicholas Carrigy, Reinhard Vehring
Long-term room temperature stability of bacteriophage in a leucine and trehalose powder stored under dry conditions has been demonstrated [126]. Stability without refrigeration is a particularly useful attribute with respect to distribution of biologics to developing countries. While dry storage is simple and practical in many applications, it may not be optimal for all biologics, as previously explained. When a powder is required to have stability at comparatively high relative humidity, the use of a high glass transition temperature polymeric excipient such as pullulan can prevent trehalose from crystallizing at high relative humidity and temperature, improving the storage stability in those conditions [320]. Excellent chemical and aggregation stability of salmon calcitonin and human growth hormone stored at high relative humidity has been demonstrated with trileucine [170].
Liposomal Nanomedicines
Published in Vladimir Torchilin, Mansoor M Amiji, Handbook of Materials for Nanomedicine, 2011
Liposomes as a dosage form allow for a broad variety of administration routes. In addition to the most traditional and frequent parenteral (intravenous) way of administration, some alternative approaches are also developed or under development, although each of these approaches has its own problems and limitations. Thus, oral administration requires high liposome stability and drug delivery from the gut to the blood with subsequent drug release.375 Early attempts with polymerized liposomes as potential oral vaccine carriers376 were only partially successful. Currently, many alternative schemes are under development. Chitosan-coated insulin liposomes were shown to cause hypoglycemic effect in mice upon oral administration.377 Liposomes made with addition of gangliosides GM1 and GM type III are stable in different biological media and can survive the GI tract.378 PEG-coated liposomes were used for oral delivery of recombinant human epidermal growth factor for gastric ulcer healing.336 Hypocalcemic effect of liposomal salmon calcitonin upon oral administration was shown in Ref. 379 PEG-liposomes are also considered for oral vaccines — ovalbumin in PEG-coated liposomes induces the best mucosal immune response of all carriers tested.380 To improve protein and peptide bioavailability via the oral route, oral colon-specific drug delivery system for bee venom peptide was developed based on coated alginate gel beads-entrapped liposomes.381
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
Chitosan is a deacetylated derivate of chitin, (a mucopolysaccharide consisting of 2-acetamido-2-deoxy-β-(1γ4)-linked D-glucose.[155] Chitosan has mucoadhesive and controlled release properties that could confer a formulation advantage. It has been shown that chitosan is able to stabilize spray-dried insulin[142] and BSA.[102] Moreover, the use of chitosan has enabled the production of inhalable protein particles with controlled release properties and improved systemic delivery.[104] In combination with mannitol and gastro-resistant polymers, chitosan has demonstrated to be able to successfully produce inhalable particles of salmon calcitonin[89] and microparticles of BSA for oral delivery,[115] respectively.
Spray-drying encapsulation of protein hydrolysates and bioactive peptides: Opportunities and challenges
Published in Drying Technology, 2020
Khashayar Sarabandi, Pouria Gharehbeglou, Seid Mahdi Jafari
Chan et al.[74] studied the effect of crystallinity degree and storage conditions at various relative humidities on physical stability of spray-dried salmon calcitonin in the pure form or in combination with mannitol (as a carrier). The powders were kept at a relative humidity of 0 to 84% for five days. The amount of moisture, changes in the secondary structure and the aggregation of proteins were evaluated after production and during storage. According to their results, keeping the samples at a high relative humidity (> 20%) led to a significant increase of aggregation. On the other hand, mannitol can prevent the formation of β-sheet structures as a result of moisture absorption and particle aggregation. Due to reducing the adhesion and aggregation of particles during storage period, the carriers increased the stability and maintained the flowability of powders loaded with proteins.[55]