Lopinavir/Ritonavir- A promising co-Formulated drug
End of December 2019 and beginning of the year 2020 marked the emergence of, a novel coronavirus, designated SARS-CoV-2, and has caused an international outbreak of respiratory illness termed Covid-19.
The full spectrum of Covid-19 ranges from mild, self-limiting respiratory tract illness to severe progressive pneumonia, multi-organ failure, and finally death.
Although there is no therapeutic treatment for coronavirus agents till date but in a hopeful finding, studies revealed that a combination of Lopinavir–Ritonavir were proven effective against SARS-CoV and MERS-CoV, the previous two coronaviruses that hit the globe.
Originally, Lopinavir/ritonavir combination is the first and only coformulated HIV-1 protease inhibitor. Clinical trials have demonstrated lopinavir/ritonavir’s immunologic and virologic benefits of treatment of HIV-infected adults, adolescents, and children.
Recently a random, controlled, open-label trial for lopinavir–ritonavir (ritonavir helps to stabilize lopinavir) in 199 hospitalized patients with severe COVID-19 was conducted and the drug showed benefit for some secondary endpoints.
Pharmaceutical parlance, medicinal fraternity and researchers are trying ways to find a promising treatment for the deadly virus. A lot of research is going on throughout the world and a lot of hard work, knowledge, infrastructure, technology and research material is required to find a cure for COVID -19.
Some of the possible known and unknown impurities of Lopinavir required in clinical trials are tabulated below:
| Product Name | Chemical Name | Cas No. |
|---|---|---|
| Lopinavir - API | Lopinavir | 192725-17-0 |
| Lopinavir - Impurity T | 2-(2,6-Dimethylphenoxy)-N-[(2S,3S,5S)-5-([[(2S,4S,5S)-5-[[(2,6-dimethylphenoxy)acetyl]amino]-4-hydroxy-1,6-diphenylhexan-2-yl]carbamoyl]amino)-3-hydroxy-1,6-diphenylhexan-2-yl]acetamide | 1797024-56-6 |
| Lopinavir - Impurity S | (2,6-Xylyloxy)acetyl Lopinavir | 943250-65-5 |
| Lopinavir - Impurity M | (2S)-N-[(1R,3R,4S)-1-Benzyl-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenylpentyl]-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanamide | NA |
| Lopinavir - Impurity L | N,N′-(Z)-Ethene-1,2-diylbis[2-(2,6-dimethylphenoxy)acetamide] | NA |
| Lopinavir - Impurity I | (2S)-N-[(1S,2S,4S)-1-Benzyl-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-2-hydroxy-5-phenylpentyl]-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanamide | NA |
| Lopinavir - Impurity A | (2S)-N-[(1S,3S,4S)-1-Benzyl-4-amino-3-hydroxy-5-phenylpentyl]-3-methyl-2-[2-oxotetrahydropyrimidin-1(2H)-yl]butanamide | 192726-05-9 |
| 4,5-Dehydro(pyrimidin-2(1H)-one) Lopinavir | 4,5-Dehydro(pyrimidin-2(1H)-one) Lopinavir | NA |
| 3-Methyl-2-(2-oxo-tetrahydro-pyrimidin-1-yl)-pentanoic Acid{1-benzyl-4-[2-(2-6,-dimethyl-phenoxy)-acetylamino]-3-hydroxy-5-phenyl-pentyl}-amide | 3-Methyl-2-(2-oxo-tetrahydro-pyrimidin-1-yl)-pentanoic Acid{1-benzyl-4-[2-(2-6,-dimethyl-phenoxy)-acetylamino]-3-hydroxy-5-phenyl-pentyl}-amide | NA |
| (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide | (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide | 192726-05-9 |
| (S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-2-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-3-methylbutanamide | (S)-N-((2S,4S,5S)-5-(2-(2,6-Dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-2-(2,4-dioxotetrahydropyrimidin-1(2H)-yl)-3-methylbutanamide | 192725-39-6 |
| (S)-N-((2S,4S,5S)-4-(((6-(Cyclopropylamino)-9-((1S,4S)-4-(hydroxymethyl)cyclopent-2-en-1-yl)-9H-purin-2-yl)amino)methoxy)-5-(2-(2,6-dimethylphenoxy)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide | (S)-N-((2S,4S,5S)-4-(((6-(Cyclopropylamino)-9-((1S,4S)-4-(hydroxymethyl)cyclopent-2-en-1-yl)-9H-purin-2-yl)amino)methoxy)-5-(2-(2,6-dimethylphenoxy)acetamido)-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide | NA |
| (2S,3S,5S)-2-Amino-3-hydroxy-5-(tert-butyloxycarbonylamino)-1,6-diphenylhexane | (2S,3S,5S)-2-Amino-3-hydroxy-5-(tert-butyloxycarbonylamino)-1,6-diphenylhexane | 144163-85-9 |
| (2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-trifluromethylcarbonylamino-1,6-diphenylhexane | (2S,3S,5S)-2-(2,6-Dimethylphenoxyacetyl)amino-3-hydroxy-5-trifluromethylcarbonylamino-1,6-diphenylhexane | NA |
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