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Screen next round of formulations - Accelerated stability at elevated T

Screen next round of formulations - Accelerated stability at elevated T

Figure 11.10 Process diagram for formulation development of proteins and peptides.

Reproduced from reference 27.

Figure 11.10 Process diagram for formulation development of proteins and peptides.

Reproduced from reference 27.

Considerations of solubility and stability have to be addressed, as well as the mode of delivery. The wide range of biodegradable polymers used for the controlled delivery of proteins and peptides include natural substances, starch, alginates, collagen and a variety of proteins such as crosslinked albumin, as well as a range of synthetic hydrogels, polyanhydrides, polyesters or orthoesters, poly(amino acids) and poly(caprolactones). Poly(lactide-glycolide)

(a) Incubation time (days) (b) Weight ratio (g sorbitol: g rHA)

Figure 11.11 Stabilisation of rHA against aggregation afforded by co-lyophilised sorbitol. (a) The time-dependent change of solubility of rHA co-lyophilised with sorbitol at various sorbitol-to-rHA weight ratios, as indicated (the dashed line depicts the time course of rHA aggregation in the absence of sorbitol). (b) rHA solubility after a one-day incubation as a function of sorbitol-to-rHA weight ratio.

Reproduced from reference 28.

(a) Incubation time (days) (b) Weight ratio (g sorbitol: g rHA)

Figure 11.11 Stabilisation of rHA against aggregation afforded by co-lyophilised sorbitol. (a) The time-dependent change of solubility of rHA co-lyophilised with sorbitol at various sorbitol-to-rHA weight ratios, as indicated (the dashed line depicts the time course of rHA aggregation in the absence of sorbitol). (b) rHA solubility after a one-day incubation as a function of sorbitol-to-rHA weight ratio.

Reproduced from reference 28.

Table 11.7 Routes of delivery for proteins and peptides0

Delivery routes

Formulation and device

Commercial products'3

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