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Liposomes
Published in Danilo D. Lasic, LIPOSOMES in GENE DELIVERY, 2019
Liposome stability is a complex issue which is composed from unrelated instabilities which on the other side synergistically cause the destabilization of the system. One can distinguish between physical (thermodynamic and colloidal), chemical, and biological stability of liposomes. In the pharmaceutical industry and in drug delivery, shelf-life stability, which is a cumulative property of physical and chemical stability, is also important.
Inhalation Drug Products Containing Nanomaterials
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Sandro R.P. da Rocha, Rodrigo S. Heyder, Elizabeth R. Bielski, Ailin Guo, Martina Steinmaurer, Joshua J. Reineke
According to the FDA (FDA 2017), the following attributes should be described and measured for any nanomaterial in a drug product: (i) chemical composition; (ii) average particle size; (iii) particle size distribution (PSD); (iv) shape and morphology; (v) physical stability; and (vi) chemical stability. The following additional attributes may also be needed to describe nanomaterials, including: (vii) assay and distribution of the API (bound/conjugated to the carrier versus free); (viii) structural attributes that relate to function (e.g. core-shell); (ix) surface properties (surface area, surface charge, ligand); (x) coating properties, including how coatings are bound to nanomaterials; (xi) porosity; (xii) particle concentration; (xiii) in vitro release; (xiv) crystal form; (xv) impurities; and (xvi) sterility and endotoxin levels. These measured attributes are in addition to characterizations required for all medical products of similar intended application (e.g. efficacy, toxicity).
Nanosuspensions as Nanomedicine: Current Status and Future Prospects
Published in Debarshi Kar Mahapatra, Sanjay Kumar Bharti, Medicinal Chemistry with Pharmaceutical Product Development, 2019
Shobha Ubgade, Vaishali Kilor, Abhay Ittadwar, Alok Ubgade
In addition to physical stability, chemical stability is an important aspect of drug delivery platforms in the pharmaceutical sciences [106]. Generally, nanosuspensions have been prepared in a dispersion medium of water or water-mixture environments, although a few processes have used non-aqueous media [107]. Therefore, chemical reactions, such as hydrolysis and oxidation, are considerable problems in the formulation of nanosuspensions and limit drug chemical stability in nanosuspensions [61]. The preparation of chemically stable nanosuspensions to prevent the hydrolysis of labile compounds remains challenging.
Stability of Cell-Penetrating Peptide anti-VEGF Formulations for the Treatment of Age-Related Macular Degeneration
Published in Current Eye Research, 2021
Naa-Dei Nikoi, Matthew Berwick, Jack A. Bryant, Lily Riordan, Louise Slope, Anna F. A. Peacock, Felicity de Cogan
Chemical stability was examined using HPLC. Six samples were prepared and stored as described above. All samples were run at a flow rate of 1 ml/min, and the column and mobile phases kept at a constant temperature of 25°C. Aliquots were run on an Agilent Infinity II series 1290 analytical HPLC with an Aeris Widepore C18-XB RP-HPLC column (250 x 21.2 C18 3.6 µm 200 Å Axia packed) in water. The gradient solvent system used consisted of solvent A (water + 0.05% trifluoroacetic acid) and solvent B (water + 0.1% trifluoroacetic acid). The gradient was run from 0–100% B over 40 minutes, with the absorbance monitored at 210 and 280 nm. Calibration samples were run from fresh bevacizumab alone, CPP alone, and bevacizumab+CPP stock solutions at concentrations ranging from 0–6.25 mg/mL for bevacizumab and 0–5 mg/mL for CPP. Uridine was run as an internal standard. The method gave a limit of quantification of 0.0856 mg/mL for bevacizumab and 0.172 mg/ml for CPP, and precisions of 3.48% and 12.0% for bevacizumab and CPP respectively. Test samples were prepared from stock by diluting 30 µL of stock solutions into 200 µL of ultrapure water. The concentration of the CPP and of bevacizumab analyzed by the peak area ratio between the analyte and the internal standard and the concentration confirmed by reference to the calibration curve. Samples were tested over the length of the study.
Solid lipid nanoparticles: a review on recent perspectives and patents
Published in Expert Opinion on Therapeutic Patents, 2020
Rishi Paliwal, Shivani Rai Paliwal, Rameshroo Kenwat, Balak Das Kurmi, Mukesh Kumar Sahu
Yong et al. 2018 disclosed an invention of bufadienolides-loaded solid lipid nanoparticle drug delivery system for injection and a preparation method thereof [142]. The composition of this formulation claimed was 0.1–2 parts of total bufadienolides with therapeutically effective amount, 0.5–20 parts of a lipid material, 0.5–15 parts of a lipid soluble emulsifier, 0.5–10 parts of a water soluble emulsifier, 0.002–2.5 part of an antioxidant, 0.1–25 parts of sugar, and a proper amount of water for injection parts by weight. These formulations provided total bufadienolides wrapped in the lipid nucleus, increased solubility and reduced irritation and degradation of drug. Inventors claimed that the formulation has good physical and chemical stability and suitable for targeted and controlled drug delivery.
Development of nanodispersion-based sildenafil metered-dose inhalers stabilized by poloxamer 188: a potential candidate for the treatment of pulmonary arterial hypertension
Published in Pharmaceutical Development and Technology, 2019
Charisopon Chunhachaichana, Rutthapol Sritharadol, Somchai Sawatdee, Paul Wan Sia Heng, Teerapol Srichana
After 6-month storage, sildenafil content and aerosol characteristics of F5–F12 were reevaluated (see Figure 8). The findings indicated a significant decrease (p < 0.01) in the amount of sildenafil delivered from F5 and F9 after 6 months, thus falling outside the acceptance limit (80–120%). Also, the FPF of F5 and F9 decreased significantly (p < 0.05), but their MMAD remained relatively unchanged. The chemical stability results were in good agreement with the data on physical stability discussed earlier. The decrease in the amount of sildenafil delivered from F5 and F9 might have caused some crystal growth on storage as the formulations did not contain P188. In addition, a significant (p < 0.01) decrease in the amount of sildenafil content in F11 and F12 was also observed after 6 months (see Figure 8(A)). The decrease in sildenafil content could be linked to high EtOH and P188 concentration which caused the instability in the canisters and could turn the formulations from solution-like nanosuspension to suspension MDIs which has fewer drug particles per droplet (Stein 2008). The instability resulted in a decrease in ED and FPF, as well as an increase in MMAD (see Figure 8(B,C)).