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Submitted
May 18, 2021
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July 1, 2022
Published
December 30, 2023
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Abstract

Background: Marketed tablets of drugs must fulfill the required standards of dissolution to guarantee the equivalent of reference. Atorvastatin calcium needs enhanced dissolution since this compound includes Biopharmaceutical Classification System (BCS) Class II drugs with low solubility and high permeability. This means that dissolution affects the bioavailability of drugs.
Objective: This research aimed to develop a formulation of atorvastatin calcium tablets by liquisolid system using propylene glycol as a solvent and some carrier materials that are equivalent to the reference product.
Method: Different formulations of liquisolid tablets were conducted using different quantities of carrier materials like Avicel PH 101, Avicel PH 102, and Neusilin US2, with Aerosil 200 as the coating material. The liquisolid powder was compressed into tablets by the direct compressing method. X-ray diffractometry (XRD) and FTIR analysis were used to find out more about the liquisolid tablets' properties and how the drug and excipients might interact with each other.
Results: The liquisolid tablets of atorvastatin calcium were within the acceptable limit criteria. The dissolution of AA4 tablets was higher compared to conventional and marketed tablets. The XRD and Fourier transform infrared (FTIR) analyses showed no chemical interactions between the drug and the excipient.
Conclusion: The liquisolid formulation can then be developed as an alternative for the production of atorvastatin calcium tablets in the pharmaceutical industry.
Keywords: Atorvastatin calcium, dissolution, liquisolid, propylene glycol


Intisari
Latar belakang: Sediaan tablet yang dipasarkan harus memenuhi standar disolusi yang ditetapkan untuk menjamin ekivalensinya dengan produk standar. Kalsium atorvastatin perlu ditingkatkan disolusinya, karena termasuk dalam kelas II Sistem Klasifikasi Biofarmasetik (BCS) dengan sifat kelarutan yang rendah dan permeabilitas yang tinggi. Disolusi kalsium atorvastatin mempengaruhi bioavailabilitasnya.
Tujuan: Penelitian ini bertujuan mengembangkan formulasi tablet likuisolid menggunakan pelarut propilen glikol dan beberapa bahan pembawa sebagai alternatif formulasi tablet kalsium atorvastatin yang bioekivalen dengan produk standar.
Metode: Tablet likuisolid dibuat dengan menambahkan berbagai komposisi bahan pembawa seperti Avicel PH 101, Avicel PH 102, dan Neusilin US2, serta Aerosil 200 sebagai pelapis pada dispersi kalsium atorvastatin dalam propilen glikol hingga terbentuk serbuk likuisolid. Serbuk likuisolid dikompresi langsung menjadi tablet setelah ditambahkan penghancur dan pelincir. Tablet likuisolid kalsium atorvastatin dievaluasi karakteristiknya dan dianalisis dengan XRD dan FTIR untuk mengetahui adanya interaksi antara zat aktif dengan eksipien yang digunakan.
Hasil: Tablet likuisolid kalsium atorvastatin memenuhi kriteria tablet dalam literatur dan kompendia. Tablet likuisolid AA4 memenuhi kriteria penerimaan uji disolusi dalam Farmakope Indonesia (FI). Hasil analisis XRD dan FTIR tablet likuisolid AA4 menunjukkan tidak ada interaksi kimia antara zat aktif dengan eksipien.
Kesimpulan: Formulasi tablet likuisolid dapat dikembangkan sebagai alternatif untuk produksi tablet kalsium atorvastatin di industri farmasi.
Kata kunci: Kalsium atorvastatin, disolusi, likuisolid, propilen glikol

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Author Biography

Yulias Ninik Windriyati, Universitas Wahid Hasyim

Department Pharmaceutic and Pharmaceutical Technology

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