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"Wabah Coronavirus yang dibebakan oleh Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2) atau yang dikenal sebagai Coronavirus-19 memiliki tingkat mortalitas yang tinggi pada 2021. Sehingga ada urgensi yang tinggi terhadap penemuan obat baru. Ivermectin terbukti secara in-vitro mampu menghambat replikasi SARS-Cov-2. Penggunaan Ivermectin secara off-label terbukti meningkatkan keberhasilan terapi pasien Coronavirus-19. Penelitian lain menyebutkan bahwa ivermectin mampu menginhibisi enzim a/β importin dan menghibisi replikasi beberapa jenis virus lainnya, termasuk dengue virus, Zika virus, yellow fever virus. Ivermectin yang dijual dengan merk dagang Ivermax 12mg dibuat oleh PT. Harsen Laboratories Indonesia, merupakan produk baru di Indonesia. Validasi Metode Analisis terhadap penentapan kadar dilakukan untuk pemenuhan persyaratan akurasi, presisi, ripitabilitas/ keterulangan, batas deteksi, batas kuantitasi, linearitas dan rrentang pengujian. Laporan tugas khusus praktik kerja apoteker ini bertujuan untuk melakukan validasi metode analisis terhadap penentuan kadar Ivermectin pada Ivermax ® 12mg.

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The Coronavirus outbreak caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-Cov-2) or known as Coronavirus-19 has a high mortality rate in 2021. There is a high urgency for the discovery of new drugs. Ivermectin has been proven in-vitro to be able to inhibit SARS-Cov-2 replication. Off-label use of Ivermectin has been proven to increase the success of therapy for Coronavirus-19 patients. Other research said that ivermectin is able to inhibit the a/β importin enzyme and inhibit the replication of several other types of viruses, including dengue virus, Zika virus, yellow fever virus. Ivermectin which is sold under the trademark Ivermax 12mg is made by PT. Harsen Laboratories Indonesia, is a new product in Indonesia. Validation of the analytical method for assay determination is carried out to fulfill the requirements for accuracy, precision, repeatability, detection limit, quantitation limit, linearity and test range. This report of work practice aims to validate the analytical method for determining Ivermectin levels in Ivermax ® 12mg."

"Ivermectin merupakan obat antihelmintik berspektrum luas yang digunakan untuk mengendalikan penyakit onchocerciasis dari parasit nematoda. Sebagai obat cacing, ivermectin didisain untuk memiliki kadar yang tinggi di saluran cerna, sehingga yang masuk sistemik tergolong rendah. Oleh karena kadar ivermectin yang sangat kecil, dibutuhkan metode yang sensitif dan selektif untuk analisis ivermectin dalam darah. Beberapa metode telah dikembangkan menggunakan plasma dan Dried Blood Spot, namun masih terdapat kekurangan karena terdapat efek hematokrit. Oleh karena itu, penelitian ini bertujuan untuk mengembangkan metode analisis ivermectin yang tervalidasi dengan baku dalam doramectin menggunakan Kromatografi Cair Kinerja Ultra Tinggi – tandem Spektrometri Massa (KCKUT-SM/SM). Deteksi menggunakan spektrometri massa triple quadrupole dengan mode electrospray ionization (ESI) positif. Matriks biologis yang digunakan yaitu darah utuh dalam Volumetric Absorptive Microsampling (VAMS), kemudian dipreparasi menggunakan metode pengendapan protein dengan campuran asetonitril dan metanol (1:1). VAMS dipilih karena tidak terdapat efek hematokrit, dibutuhkan volume sampel yang sedikit dan akurat, serta pengambilannya lebih efisien. Kondisi analisis optimum diperoleh menggunakan kolom Acquity® UPLC BEH C18 (2,1 x 100 mm; 1,7 m); fase gerak amonium format 5 mM pH 3 dan asetonitril (10:90); laju alir 0,2 mL/menit; mode elusi isokratik selama 5 menit dengan suhu kolom 50˚C; deteksi menggunakan Multiple Reaction Monitoring (MRM) pada nilai m/z 892,41 > 569,5 untuk ivermectin dan 916,41 > 331,35 untuk doramectin. Metode analisis telah tervalidasi seluruhnya mengikuti pedoman dari US Food and Drug Administration tahun 2018. Nilai LLOQ 1 ng/mL dengan rentang konsentrasi linear pada 1 - 150 ng/mL

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Ivermectin is a broad-spectrum anthelmintic used to control onchocerciasis from nematode parasites. As an anthelmintic, ivermectin is designed to have high levels in the gastrointestinal tract, so that the systemic intake is relatively low. Due to the very small concentration of ivermectin, a sensitive and selective method is needed for the analysis of ivermectin in blood. Several methods have been developed using plasma and Dried Blood Spots, but there are still shortcomings due to hematocrit effects. Therefore, this study was conducted to develop a validated ivermectin analysis method with doramectin as the internal standard in using Ultra High Performance Liquid Chromatography-Tandem Mass Spectrometry. The analysis was performed using a triple quadrupole mass spectrometry with positive electrospray ionization (ESI) mode. The biological matrix used whole blood in Volumetric Absorptive Microsampling (VAMS) and extracted using the protein precipitation method with mixture of acetonitrile and methanol (1:1). VAMS has some advantages such as not affected by hematocrit, requires small and fixed volume of sample, also more efficient sampling process. The optimum conditions were obtained using the Acquity® UPLC BEH C18 column (2.1 x 100 mm; 1,7 m); flow rate was 0,2 mL/min; mobile phase was ammonium formate 5 mM pH 3 and acetonitrile (10:90); isocratic elusion for 5 minutes; Multiple Reaction Monitoring (MRM) detection with m/z values were 892.41 > 569.5 for ivermectin and 916,41 > 331,35 for doramectin. The method has been fully validated following the guidelines from US FDA (2018). LLOQ value was 1 ng/mL with a linear concentration range of 1 – 150 ng/mL."

"Ivermectin merupakan obat yang telah disetujui FDA untuk digunakan pada Strongyloidiasis dan Onchocerciasis, yaitu dua kondisi yang disebabkan oleh cacing parasit. Namun ivermectin banyak disalahgunakan sebagai obat COVID-19 yang sebenarnya membutuhkan dosis berkali lipat agar konsentrasi plasma yang dibutuhkan untuk efikasi antivirus tercapai. Oleh karena itu, perlu dilakukan uji profil farmakokinetika untuk mengetahui keamanan, efikasi, serta toksisitas suatu obat. Pengujian ini dilakukan dengan menganalisis kadar ivermectin pada plasma 6 orang subjek Indonesia sehat yang telah mengonsumsi tablet ivermectin 12 mg secara oral menggunakan Kromatografi Cair Kinerja Ultra Tinggi Tandem Spektrometri Massa (KCKUT-SM/SM). Pengambilan darah subjek dilakukan sebanyak 16 titik pada beberapa interval waktu hingga jam ke-72. Kondisi kromatografi yang digunakan adalah kolom Acquity UPLC BEH C18 (2,1 x 100 mm x 1,7 µm); suhu kolom 40oC; fase gerak amonium format 5 mM pH 3 – asetonitril dengan perbandingan 10:90; laju alir 0,2 mL/menit; dan doramectin sebagai baku dalam. Profil farmakokinetika dalam sampel plasma menghasilkan; AUC0-t 518,43 ± 71,89 ng/mL; AUC0- 582,92 ± 114,28 ng/mL; Cmaks 47,79 – 53,31 ng/mL; tmaks 4,50 ± 0,00 jam; dan t½ 23,15 ± 6,81 jam. Berdasarkan penelitian sebelumnya, Cmaks in vitro yang dibutuhkan untuk mematikan virus COVID-19 yaitu sebesar ± 5 µg/mL, apabila dibandingkan dengan Cmaks yang diperoleh pada penelitian ini, memperoleh kesimpulan bahwa konsentrasi untuk mematikan virus COVID-19 tidak tercapai.

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Ivermectin is a drug approved by FDA that used for Strongyloidiasis and Onchocerciasis, two conditions caused by parasitic worms. However, ivermectin is widely misused as a COVID-19 drug which requires multiple doses to achieve the plasma concentration required for antiviral efficacy. Therefore, it is necessary to test the pharmacokinetic profile to determine the safety, efficacy, and toxicity of the drug. This test was done by analizing the ivermectin levels in the plasma of 6 healthy Indonesian subjects who had taken 12 mg of ivermectin tablet orally by using Ultra High Performance Liquid Chromatography Tandem – Mass Spectrmetry (UHPLC-MS/MS). Subjects’ blood sampling was collected as many as 16 points at several time intervals up to 72 hours. The chromatographic conditions used was Acquity UPLC BEH C18 column (2.1 x 100 mm x 1.7 µm); 40oC column temperature; mobile phase consists of ammonium formate 5 mM pH 3 – acetonitrile with 10:90 comparison; 0,2 mL/minute flow rate; and doramectin as an internal standard. The pharmacokinetic profile in plasma results were; AUC0-t was 518,43 ± 71,89 ng/mL; AUC0- was 582,92 ± 114,28 ng/mL; Cmax ranged from 47,79 to 53,31 ng/mL; tmax was 4,50 ± 0,00 hours; and t½ was 23,15 ± 6,81 hours. Based on previous research, the in vitro Cmax required to kill the COVID-19 virus is ± 5 g/mL, when compared with the Cmax obtained in this study, it is concluded that the concentration to kill the COVID-19 virus was not achieved."

"Ivermectin merupakan obat yang digunakan secara luas untuk mengendalikan dan mengobati spektrum luas infeksi yang disebabkan oleh parasit nematoda khususnya onchocerciasis. Oleh karena ivermectin didisain untuk obat cacing, maka kadar diusahakan tinggi di saluran cerna, sehingga yang masuk sistemik rendah. Kadar ivermectin yang sangat kecil, memerlukan metode analisis yang sensitif dan selektif. Penelitian ini bertujuan untuk mendapatkan metode analisis yang sensitif dan selektif serta tervalidasi menggunakan Kromatografi Cair Kinerja Ultra Tinggi – tandem Spektrometri Massa (KCKUT-SM/SM). Analisis ivermectin dilakukan dengan menggunakan kolom C18 Acquity® Bridged Ethylene Hybrid (BEH) 1,7 μm, 100 x 2,1 mm. Matriks biologi yang digunakan plasma dengan baku dalam doramectin. Preparasi sampel menggunakan pelarut pengendapan protein yaitu campuran metanol dan asetonitril dengan perbandingan (1:1 v/v). Kondisi analisis optimum diperoleh dengan fase gerak berupa amonium format 5mM pH 3 – asetonitril (10:90 v/v) dengan laju alir 0,2 mL/menit dan dielusi secara isokratik selama 5 menit. Kuantifikasi analisis dilakukan menggunakan spektrometri massa triple quandrupole dengan mode electrospray ionization (ESI) positif; deteksi pada m/z 892,41 > 569,5 untuk ivermectin dan m/z 916,41 > 331,35 untuk doramectin. Metode analisis tervalidasi mengikuti pedoman US Food and Drug Adminitration (FDA) tahun 2018 dengan rentang konsentrasi linear pada 0,5-200 ng/ml.

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Ivermectin is a drug that is widely used to control and treat a broad spectrum of infections caused by parasitic nematodes, especially onchocerciasis. Because ivermectin is designed for deworming, then the concentration must be higher in the gastrointestinal tract so that what goes into systemic is low. Low levels of ivermectin in plasma require sensitive and selective analytical methods. This study aims to obtain a sensitive, selective, and validated analytical method using Ultra-High Performance Liquid Chromatography Tandem Mass Spectrometry (UPLC-/MS/MS). Ivermectin analysis was performed using a C18 Acquity® Bridged Ethylene Hybrid (BEH) column of 1.7 μm; 100 x 2.1 mm. The biological matrix used was plasma with doramectin as the internal standard. Sample preparation used a protein precipitation solvent in the form of a mixture of methanol and acetonitrile with a ratio (1:1 v/v). The optimum analysis conditions were obtained in the mobile phase of the combination ammonium formate 5mM pH 3 – acetonitrile (10:90 v/v) with a flow rate of 0.2 mL/minute and eluted isocratically for 5 minutes. Quantification analysis was performed using triple quadrupole mass spectrometry with positive electrospray ionization (ESI) mode; detection at m/z 892.41 > 569.5 for ivermectin and m/z 916.41 > 331.35 for doramectin. The validated analytical method follows the 2018 US Food and Drug Administration (FDA) guidelines with a linear concentration range of 0.5-200 ng/ml."

"Malaria merupakan penyakit demam akut yang disebabkan oleh parasit Plasmodium dan ditularkan dari manusia ke manusia melalui gigitan nyamuk Anopheles betina yang terinfeksi. Upaya pengendalian vektor nyamuk berskala besar terus dilakukan sebagai kontrol terhadap penyebaran malaria, sebagai contoh upaya fumigasi atau larvasida. Ancaman terbesar dalam upaya tersebut adalah munculnya resistensi terhadap insektisida dan perubahan perilaku pada nyamuk. Dalam menghadapi ancaman tersebut, penggunaan Ivermectin dikaji oleh WHO sejak 2016 sebagai salah satu metode alternatif baru dalam pengendalian vektor. Berdasarkan hal tersebut, pada skripsi ini dikaji potensi dari Ivermectin dan fumigasi dengan menggunakan pendekatan model matematika sebagai sistem persamaan diferensial biasa. Kajian analitik dilakukan untuk melihat kemungkinan kondisi akhir di lapangan terkait dengan intervensi Ivermectin dan fumigasi. Data yang digunakan dalam penelitian mengacu pada data akumulasi kasus baru yang terdeteksi di rumah sakit Papua setiap bulannya sejak bulan Januari 2017 hingga Desember 2020. Lebih lanjut, dari model matematika yang terbentuk, dilakukan kajian numerik untuk mengilustrasikan dinamik populasi manusia dan nyamuk terhadap perubahan waktu.

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Malaria is an acute febrile disease caused by the Plasmodium parasites and transmitted from human to human through the bite of an infected female Anopheles mosquito. Large-scale vector control continues to be carried out to prevent the spread of malaria, for instance, through fumigation or larvicide. The biggest threat in this effort is the emergence of resistance to insecticides and behavioral changes in mosquitoes. In dealing with this threat, Ivermectin has been studied by WHO since 2016 as one of the new alternative methods in vector control. Based on this, this thesis examines the potential of Ivermectin and fumigation using a mathematical model approach as a system of ordinary differential equations. Analytical studies were conducted to determine the possible final conditions in the field related to the Ivermectin and fumigation interventions. The data used in the study refers to data on the accumulation of new cases detected in Papua hospitals every month from January 2017 to December 2020. Furthermore, from the mathematical model formed, a numerical study was conducted to illustrate the dynamics of human and mosquito populations with respect to time changes."

"Corona Virus 2019 (COVID-19) ialah penyakit menular yang berkembang sejak bulan Desember 2019 di Wuhan, ibu kota Provinsi Hubei China, sejak itu virus ini menyebar keseluruh dunia dan menjadi global pandemi. Di Indonesia, pada Juli 2021, dikeluarkanlah surat edaran tentang Pelaksanaan Distribusi Obat dengan Persetujuan Darurat untuk penanganan terapi COVID-19 yaitu; Remdesivir, Favipiravir, Oseltamivir, Immunoglobulin, Ivermectin, Tocilizumab, Azithromycin dan Dexamethasone. Pasien yang ingin membeli obat yang mengindikasikan COVID-19 diwajibkan membawa resep dokter. Analisis resep dilakukan sesuai dengan Surat Edaran (SE), meninjau aspek administratif, aspek farmasetik dan aspek klinis. Hasil penelitian ini dapat disimpulkan bahwa terdapat 11 resep pengobatan COVID-19 pada bulan Juli 2021. Terjadi ketidaklengkapan kajian resep baik secara administrasi, farmasetik, serta aspek klinis. Namun seluruh resep telah memiliki ketepatan indikasi dan dosis.

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Corona Virus 2019 (COVID-19) is an infectious disease that developed in December 2019 in Wuhan, the capital of China's Hubei Province, since then this virus has spread throughout the world and has become a global pandemic. In Indonesia, in July 2021, a circular letter regarding the Implementation of Drug Distribution with Emergency Approval was issued for the handling of COVID-19 therapy, namely; Remdesivir, Favipiravir, Oseltamivir, Immunoglobulin, Ivermectin, Tocilizumab, Azithromycin, and Dexamethasone. Patients who want to buy drugs that indicate COVID-19 are required to bring a doctor's prescription. Prescription analysis was carried out by the Circular Letter, reviewing administrative aspects, pharmaceutical aspects, and clinical aspects. The results of this study can be concluded that there were 11 prescriptions for COVID-19 treatment in July 2021. There were incomplete prescription studies both administratively, pharmaceutically, and clinically. However, all prescriptions have accurate indications and dosages.

Vitacimin is a lozenge product containing vitamin C, produced by PT Takeda Indonesia. The high demand for Vitamin C products has continued to surge dramatically since the global entry of the COVID-19 pandemic in Indonesia in early 2020. With the increasing market demand for Vitacimin, it is also necessary to analyze and optimize the duties and work of employees (packers) in packaging Vitacimin products. This observation is focused on line 3 secondary packaging using machine vision tools that have optical functions, namely object inspection and inspection and pattern recognition. The machine vision tool used is Camera Vision Baumer, which is currently running on a trial period by placing employees who serve as selectors and back up the Camera Vision function. In this study, it can be concluded that the Camera Vision Baumer tool works well and the selector in charge of performing the back up function of the Camera Vision Baumer task can be switched."