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Modification of α-lactose monohydrate as a direct compression excipient using roller compaction.
Drug Dev Ind Pharm. 2018 Dec; 44(12):2038-2047.DD

Abstract

Roller compaction was used to prepare a direct-compressed lactose excipient using crystalline α-lactose monohydrate. The effect of various roller compaction process parameters (compaction pressure, compaction repetition, and speed ratio) on the characteristics of compacted α-lactose monohydrate was investigated. Results were compared with data obtained using industrial spray-dried lactose and lactose samples with different degrees of crystallinity. XRPD analysis revealed that roller compaction reduced the crystallinity of α-lactose monohydrate, and the resulting material is similar to spray-dried lactose in behavior as a direct compression excipient. Roller compaction introduced desirable characteristics to the raw α-lactose monohydrate by inducing changes in crystallinity and particle morphology. Scanning electron microscopy results indicated that the compaction process converted some of the original torpedo-shaped crystals of α-lactose monohydrate into a more cylindrical shape with rounded edges. Compaction pressure and repetition of compaction have a significant effect on the modification of the crystallinity of the processed, raw α-lactose monohydrate.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Abu Fara D
a Chemical Engineering Department, School of Engineering , University of Jordan , Amman , Jordan.
Rashid I
b The Jordanian Pharmaceutical Manufacturing Co , Naor , Jordan.
Alkhamis K
c Faculty of Pharmacy , University of Jordan for Science and Technology , Irbid , Jordan.
Al-Omari M
b The Jordanian Pharmaceutical Manufacturing Co , Naor , Jordan.
Chowdhry BZ
d Faculty of Engineering & Science , University of Greenwich (Medway Campus) , Chatham Maritime , Kent , UK.
Badwan A
b The Jordanian Pharmaceutical Manufacturing Co , Naor , Jordan.

MeSH

Chemistry, PharmaceuticalDrug CompoundingExcipientsLactoseParticle SizePowdersPressureTablets

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30095020

Citation

Abu Fara, Deeb, et al. "Modification of Α-lactose Monohydrate as a Direct Compression Excipient Using Roller Compaction." Drug Development and Industrial Pharmacy, vol. 44, no. 12, 2018, pp. 2038-2047.
Abu Fara D, Rashid I, Alkhamis K, et al. Modification of α-lactose monohydrate as a direct compression excipient using roller compaction. Drug Dev Ind Pharm. 2018;44(12):2038-2047.
Abu Fara, D., Rashid, I., Alkhamis, K., Al-Omari, M., Chowdhry, B. Z., & Badwan, A. (2018). Modification of α-lactose monohydrate as a direct compression excipient using roller compaction. Drug Development and Industrial Pharmacy, 44(12), 2038-2047. https://doi.org/10.1080/03639045.2018.1508224
Abu Fara D, et al. Modification of Α-lactose Monohydrate as a Direct Compression Excipient Using Roller Compaction. Drug Dev Ind Pharm. 2018;44(12):2038-2047. PubMed PMID: 30095020.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Modification of α-lactose monohydrate as a direct compression excipient using roller compaction. AU - Abu Fara,Deeb, AU - Rashid,Iyad, AU - Alkhamis,Khouloud, AU - Al-Omari,Mahmoud, AU - Chowdhry,B Z, AU - Badwan,Adnan, Y1 - 2018/09/05/ PY - 2018/8/11/pubmed PY - 2019/2/20/medline PY - 2018/8/11/entrez KW - Co-processing KW - crystallinity KW - dry granulation KW - lactose KW - roller compaction KW - spray dried lactose KW - xrpd SP - 2038 EP - 2047 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 44 IS - 12 N2 - Roller compaction was used to prepare a direct-compressed lactose excipient using crystalline α-lactose monohydrate. The effect of various roller compaction process parameters (compaction pressure, compaction repetition, and speed ratio) on the characteristics of compacted α-lactose monohydrate was investigated. Results were compared with data obtained using industrial spray-dried lactose and lactose samples with different degrees of crystallinity. XRPD analysis revealed that roller compaction reduced the crystallinity of α-lactose monohydrate, and the resulting material is similar to spray-dried lactose in behavior as a direct compression excipient. Roller compaction introduced desirable characteristics to the raw α-lactose monohydrate by inducing changes in crystallinity and particle morphology. Scanning electron microscopy results indicated that the compaction process converted some of the original torpedo-shaped crystals of α-lactose monohydrate into a more cylindrical shape with rounded edges. Compaction pressure and repetition of compaction have a significant effect on the modification of the crystallinity of the processed, raw α-lactose monohydrate. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/30095020/Modification_of_��_lactose_monohydrate_as_a_direct_compression_excipient_using_roller_compaction_ DB - PRIME DP - Unbound Medicine ER -