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Sericin Inhibits Devitrification of Amorphous Drugs.
AAPS PharmSciTech 2019; 20(7):285AP

Abstract

The purpose of the present investigation was to analyze devitrification of amorphous drugs such as lornoxicam, meloxicam, and felodipine in the presence of sericin. The binary solid dispersions comprising varying mass ratios of drug and sericin were subject to amorphization by spray drying, solvent evaporation, ball milling, and physical mixing. Further, obtained solid dispersions (SDs) were characterized by HPLC, ATR-FTIR, H1NMR, molecular docking, accelerated stability study at 40°C and 75 ± 2% RH (XRD and DSC), and in vitro dissolution studies. The HPLC analysis indicated no decomposition of the drugs during the spray drying process. From ATR-FTIR, NMR, and molecular docking study, it was revealed that H-bonding played a vital role in amorphous drug stabilization. An excellent devitrification inhibition was observed in case of lornoxicam (SDLS3) and meloxicam (SDMS3) SDs prepared by spray drying. On the other hand, spray-dried SD of felodipine (SDFS3) showed traces of microcrystals. The percent crystallinity of SDLS3, SDMS3, and SDFS3 was found to be 7.4%, 8.23%, and 18.31% respectively indicating adequate amorphization. The dissolution performance of SDLS, SDMS, and SDFS after 3 months showed > 85% than SDs prepared by other methods. Thus, sericin significantly inhibited crystallization and was responsible for amorphous state stabilization of pharmaceuticals.

Authors+Show Affiliations

Department of Pharmaceutics, Adarsh College of Pharmacy, Vita, Maharashtra state, 415311, India.Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra state, 416013, India. nrjadhav18@rediffmail.com.Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra state, 416013, India.Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra state, 416013, India.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31407105

Citation

Salunkhe, Nitin, et al. "Sericin Inhibits Devitrification of Amorphous Drugs." AAPS PharmSciTech, vol. 20, no. 7, 2019, p. 285.
Salunkhe N, Jadhav N, More H, et al. Sericin Inhibits Devitrification of Amorphous Drugs. AAPS PharmSciTech. 2019;20(7):285.
Salunkhe, N., Jadhav, N., More, H., & Choudhari, P. (2019). Sericin Inhibits Devitrification of Amorphous Drugs. AAPS PharmSciTech, 20(7), p. 285. doi:10.1208/s12249-019-1475-z.
Salunkhe N, et al. Sericin Inhibits Devitrification of Amorphous Drugs. AAPS PharmSciTech. 2019 Aug 12;20(7):285. PubMed PMID: 31407105.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sericin Inhibits Devitrification of Amorphous Drugs. AU - Salunkhe,Nitin, AU - Jadhav,Namdeo, AU - More,Harinath, AU - Choudhari,Prafulla, Y1 - 2019/08/12/ PY - 2019/04/08/received PY - 2019/07/10/accepted PY - 2019/8/14/entrez KW - amorphous solid dispersions (ASD) KW - devitrification KW - dissolution KW - sericin KW - solubility SP - 285 EP - 285 JF - AAPS PharmSciTech JO - AAPS PharmSciTech VL - 20 IS - 7 N2 - The purpose of the present investigation was to analyze devitrification of amorphous drugs such as lornoxicam, meloxicam, and felodipine in the presence of sericin. The binary solid dispersions comprising varying mass ratios of drug and sericin were subject to amorphization by spray drying, solvent evaporation, ball milling, and physical mixing. Further, obtained solid dispersions (SDs) were characterized by HPLC, ATR-FTIR, H1NMR, molecular docking, accelerated stability study at 40°C and 75 ± 2% RH (XRD and DSC), and in vitro dissolution studies. The HPLC analysis indicated no decomposition of the drugs during the spray drying process. From ATR-FTIR, NMR, and molecular docking study, it was revealed that H-bonding played a vital role in amorphous drug stabilization. An excellent devitrification inhibition was observed in case of lornoxicam (SDLS3) and meloxicam (SDMS3) SDs prepared by spray drying. On the other hand, spray-dried SD of felodipine (SDFS3) showed traces of microcrystals. The percent crystallinity of SDLS3, SDMS3, and SDFS3 was found to be 7.4%, 8.23%, and 18.31% respectively indicating adequate amorphization. The dissolution performance of SDLS, SDMS, and SDFS after 3 months showed > 85% than SDs prepared by other methods. Thus, sericin significantly inhibited crystallization and was responsible for amorphous state stabilization of pharmaceuticals. SN - 1530-9932 UR - https://www.unboundmedicine.com/medline/citation/31407105/Sericin_Inhibits_Devitrification_of_Amorphous_Drugs L2 - https://dx.doi.org/10.1208/s12249-019-1475-z DB - PRIME DP - Unbound Medicine ER -