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Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407.
AAPS PharmSciTech 2017; 18(6):2303-2315AP

Abstract

The aim of the present context was to develop and evaluate a Kolliphor® P407-based transdermal gel formulation of diclofenac sodium by hot melt extrusion (HME) technology; central composite design was used to optimize the formulation process. In this study, we have explored first time ever HME as an industrially feasible and continuous manufacturing technology for the manufacturing of gel formulation using Kolliphor® P407 and Kollisolv® PEG400 as a gel base. Diclofenac sodium was used as a model drug. The HME parameters such as feeding rate, screw speed, and barrel temperature were crucial for the semisolid product development, and were optimized after preliminary trials. For the processing of the gel formulation by HME, a modified screw design was used to obtain a uniform product. The obtained product was evaluated for physicochemical characterization such as differential scanning calorimetry (DSC), X-ray diffraction (XRD), pH measurement, rheology, surface tension, and texture profile analysis. Moreover, it was analyzed for general appearance, spreadibility, surface morphology, and drug content. The optimized gel formulation showed homogeneity and transparent film when applied on a glass slide under microscope, pH was 7.02 and uniform drug content of 100.04 ± 2.74 (SD = 3). The DSC and XRD analysis of the HME gel formulation showed complete melting of crystalline API into an amorphous form. The Kolliphor® P407 and Kollisolv® PEG400 formed excellent gel formulation using HME with consistent viscoelastic properties of the product. An improved drug release was found for the HME gel, which showed a 100% drug release than that of a marketed product which showed only 88% of drug release at the end of 12 h. The Flux value of the HME gel was 106 than that of a marketed formulation, which showed only about 60 value, inferring a significant difference (P < 0.05) at the end of 1 h. This study demonstrates a novel application of the hot melt extrusion process for manufacturing of topical semisolid products.

Authors+Show Affiliations

BASF India Ltd, Pharma Solutions, Plot No. 12, TTC Area, Thane Belapur Road, Turbhe, Navi Mumbai, 400705, India. jaywantpawar.ict@gmail.com. Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, University under Section-3 of UGC Act-1956, Elite Status & Centre of Excellence - Govt. of Maharashtra, N. P. Marg, Matunga, Mumbai, 400019, India. jaywantpawar.ict@gmail.com.BASF India Ltd, Pharma Solutions, Plot No. 12, TTC Area, Thane Belapur Road, Turbhe, Navi Mumbai, 400705, India.Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, University under Section-3 of UGC Act-1956, Elite Status & Centre of Excellence - Govt. of Maharashtra, N. P. Marg, Matunga, Mumbai, 400019, India.BASF India Ltd, Pharma Solutions, Plot No. 12, TTC Area, Thane Belapur Road, Turbhe, Navi Mumbai, 400705, India.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28108974

Citation

Pawar, Jaywant, et al. "Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process With Kolliphor® P407." AAPS PharmSciTech, vol. 18, no. 6, 2017, pp. 2303-2315.
Pawar J, Narkhede R, Amin P, et al. Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407. AAPS PharmSciTech. 2017;18(6):2303-2315.
Pawar, J., Narkhede, R., Amin, P., & Tawde, V. (2017). Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407. AAPS PharmSciTech, 18(6), pp. 2303-2315. doi:10.1208/s12249-017-0713-5.
Pawar J, et al. Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process With Kolliphor® P407. AAPS PharmSciTech. 2017;18(6):2303-2315. PubMed PMID: 28108974.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407. AU - Pawar,Jaywant, AU - Narkhede,Rajkiran, AU - Amin,Purnima, AU - Tawde,Vaishali, Y1 - 2017/01/20/ PY - 2016/10/18/received PY - 2017/01/03/accepted PY - 2017/1/22/pubmed PY - 2018/3/31/medline PY - 2017/1/22/entrez KW - diclofenac sodium KW - gel KW - hot melt extrusion KW - kolliphor® P407 KW - kollisolv® PEG 400 KW - stability KW - texture analyzer SP - 2303 EP - 2315 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 18 IS - 6 N2 - The aim of the present context was to develop and evaluate a Kolliphor® P407-based transdermal gel formulation of diclofenac sodium by hot melt extrusion (HME) technology; central composite design was used to optimize the formulation process. In this study, we have explored first time ever HME as an industrially feasible and continuous manufacturing technology for the manufacturing of gel formulation using Kolliphor® P407 and Kollisolv® PEG400 as a gel base. Diclofenac sodium was used as a model drug. The HME parameters such as feeding rate, screw speed, and barrel temperature were crucial for the semisolid product development, and were optimized after preliminary trials. For the processing of the gel formulation by HME, a modified screw design was used to obtain a uniform product. The obtained product was evaluated for physicochemical characterization such as differential scanning calorimetry (DSC), X-ray diffraction (XRD), pH measurement, rheology, surface tension, and texture profile analysis. Moreover, it was analyzed for general appearance, spreadibility, surface morphology, and drug content. The optimized gel formulation showed homogeneity and transparent film when applied on a glass slide under microscope, pH was 7.02 and uniform drug content of 100.04 ± 2.74 (SD = 3). The DSC and XRD analysis of the HME gel formulation showed complete melting of crystalline API into an amorphous form. The Kolliphor® P407 and Kollisolv® PEG400 formed excellent gel formulation using HME with consistent viscoelastic properties of the product. An improved drug release was found for the HME gel, which showed a 100% drug release than that of a marketed product which showed only 88% of drug release at the end of 12 h. The Flux value of the HME gel was 106 than that of a marketed formulation, which showed only about 60 value, inferring a significant difference (P < 0.05) at the end of 1 h. This study demonstrates a novel application of the hot melt extrusion process for manufacturing of topical semisolid products. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/28108974/Design_and_Evaluation_of_Topical_Diclofenac_Sodium_Gel_Using_Hot_Melt_Extrusion_Technology_as_a_Continuous_Manufacturing_Process_with_Kolliphor®_P407_ L2 - https://dx.doi.org/10.1208/s12249-017-0713-5 DB - PRIME DP - Unbound Medicine ER -