Effect of Surfactants on the Physical Stability of Recombinant Human Growth Hormone

Katakam, Manohar; Bell, Leonard N.; Banga, Ajay K.

doi:10.1002/jps.2600840609

Cited by 168 publications

(107 citation statements)

References 17 publications

(1 reference statement)

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“…Spantide II showed good chemical stability in the lotion and gel formulations. The gel stability results are similar to published studies, which show that the stability of urease, interleukin-2, 12 and recombinant human growth hormone 16 was enhanced when formulated in PF127. This is a nontoxic block polymer with a molecular weight of 13 500 that exhibits reversible thermal gelation.…”

Section: Release Of Spantide II From Gel Formulations Through Synthetsupporting

confidence: 88%

In vitro and in vivo evaluation of topical formulations of Spantide II

et al. 2005

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The purpose of this study was to develop and evaluate topical formulations of Spantide II, a neurokinin-1 receptor (NK-1R) antagonist, for the treatment of inflammatory skin disorders. Spantide II lotion and gel was formulated with and without n-methyl-2-pyrrolidone (NMP) as a penetration enhancer. The release of Spantide II from gels was evaluated using microporous polyethylene and polypropylene membranes in a Franz Diffusion cell setup. In vitro percutaneous absorption of Spantide II from lotion and gel formulations was evaluated using the above setup by replacing the membranes with hairless rat skin. The in vivo anti-inflammatory activity of Spantide II formulations was evaluated in an allergic contact dermatitis (ACD) mouse model. Among different gels studied, PF127 gel showed highest (70-fold) release of Spantide II compared with hydroxypropyl methylcellulose (HPMC) and hydroxypropyl cellulose (HPC) gels. Lotion and gel formulations with or without NMP showed no detectable levels of Spantide II in the receiver compartment of the Franz diffusion cell until 24 hours. However, Spantide II showed significant retention in epidermis and dermis from lotion and gel formulations at 24 hours. The dermal levels increased~3.5-and 2-fold when the lotion and gel formulations contained NMP as compared with the formulation with no NMP (P G .05). The in vivo studies indicated that Spantide II formulations with NMP were effective in significantly reducing ACD response, similar to dexamethasone (0.5 mM). In conclusion, Spantide II was stable as a topical formulation and delivered to target skin tissue (epidermis and dermis) for the treatment of ACD. In addition this study supports the role of cutaneous neurosensory system in modulating inflammatory responses in the skin.

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Section: Release Of Spantide II From Gel Formulations Through Synthetsupporting

confidence: 88%

In vitro and in vivo evaluation of topical formulations of Spantide II

et al. 2005

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“…Polysorbates are widely used to protect biological drug products from unfolding, aggregation, and precipitation during shipping and handling (5)(6)(7). Polysorbates to be used in biotechnology products are required to be produced using strictly plant sources.…”

Section: Introductionmentioning

confidence: 99%

Effect of Polysorbate 80 Quality on Photostability of a Monoclonal Antibody

et al. 2012

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Abstract. Polysorbate 80 is one of the key components of protein formulations. It primarily inhibits interfacial damage of the protein molecule due to mechanical stress during shipping and handling. However, polysorbate 80 also affects the formulation photostability. Exposure to light of polysorbate 80 aqueous solution results in peroxide generation, which in turn may result in oxidation of the susceptible amino acid residues in the protein molecule. The purpose of this study was to determine if the photostability of our proprietary IgG 1 monoclonal antibody formulation containing polysorbate 80 is affected by the quality (grade/vendor) of polysorbate 80. Following four types of polysorbate80 were tested: (1) Polysorbate 80 Super-Refined, Mallinckrodt Baker, (2) Polysorbate 80 NF, Mallinckrodt Baker, (3) Polysorbate 80 NF, EMD Chemicals, and (4) Ultra-pure Polysorbate 80 (HX), NOF Corporation. The samples were exposed to light as per ICH guidelines Q1B. The results of the study show that photostability of the antibody formulation is indeed affected by the quality of polysorbate 80. This study underscores the importance of carefully choosing the quality of polysorbate 80 to ensure the robustness of formulation.

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“…18 The use of hydrophilic matrices (polymers) is a common practice for elongating the release of drugs as they are proven to be safe and effective. Pluronics have been cited in the literature as being used as hydrophilic thermosensitive polymers for sustaining the action of many hydrophilic drugs given by injection, such as interleukin-2, 19 recombinant human growth hormone, 20 and deslorelin. 21 Pluronics are a family of commercially available block copolymers with variable surface properties.…”

Section: Introductionmentioning

confidence: 99%

Sustained-release progesterone nanosuspension following intramuscular injection in ovariectomized rats

Salem¹

2010

IJN

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Abstract:The production of an intramuscular (IM) injection of natural progesterone would provide a safer solution than using semi synthetic progesterone. However, disadvantages such as low solubility and a short half life prevent the use of natural progesterone. In this study, we formulated a sustained release form of natural progesterone to be given as IM injection. A progesterone nanosuspension (PNS) was first developed and then dispersed in a thermosensitive gel matrix. The selected nanoparticles showed an average particle size of 267 nm and a zeta potential approaching-41 mV. The in vitro release profile of PNS from the F127 plus methyl cellulose gel followed zero order kinetics and correlated linearly with the weight percentage of gel dissolved, demonstrating that the overall rate of release of PNS is controlled by dissolution of the pluronic F127/methyl cellulose (MC) gel (r 2 . 0.99). The pharmacokinetic parameters of the PNS (6 mg/mL) in pluronic F127/MC gel were evaluated in comparison with the control progesterone suspension. After the administration of PNS in F127/MC gel into the rats, a maximum serum concentration of 22.1 ± 1.9 ng/mL was reached at a T max of 4.05 ± 0.1 h. The terminal half life was 12.7 ± 0.8 h. The area under the curve AUC 0-∞ of the injected formula was 452.75 ± 42.8 ng·h/mL and the total mean residence time was 18.57 ± 1.44 h. The PNS in gel was significantly different from the control in rate and extent at P , 0.001. The natural progesterone which was nanosized and formulated in a thermosensitive gel significantly sustained the action of natural progesterone so that it could be injected every 36 h instead of every day. Moreover, this formula is expected to provide a much safer choice than the use of semi-synthetic progesterone.

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Effect of Surfactants on the Physical Stability of Recombinant Human Growth Hormone

Cited by 168 publications

References 17 publications

In vitro and in vivo evaluation of topical formulations of Spantide II

In vitro and in vivo evaluation of topical formulations of Spantide II

Effect of Polysorbate 80 Quality on Photostability of a Monoclonal Antibody

Sustained-release progesterone nanosuspension following intramuscular injection in ovariectomized rats

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