Kajian Potensi Inkompatibilitas dan Instabilitas: Studi Kasus Sediaan Racikan Mengandung Amitriptilin, Trifluoperazine Dihidroklorida dan Alprazolam

Desi Amroni Kasanah, Dina Christin Ayuning Putri, Sri Hartati Yuliani, Rini Dwiastuti

Abstract

Meracik obat merupakan salah satu tugas tenaga kefarmasian. Peracikan obat merupakan salah satu risiko penyebab medication error. Resep racikan yang mengandung amitriptilin, trifluoperazin dihidroklorida dan alprazolam adalah jenis peresepan dengan tingkat risiko tinggi, sedangkan informasi tentang sediaan racikan kombinasi obat tersebut masih sangat terbatas. Studi ini bertujuan untuk memberikan informasi mengenai risiko peracikan, potensi instabilitas, dan potensi inkompatibilitas pada resep racikan sediaan kapsul yang mengandung amitriptilin, trifluoperazin dihidroklorida dan alprazolam di sebuah rumah sakit di Semarang. Analisis risiko resep dilakukan dengan memperhatikan aspek risiko teknis dan risiko klinis, sedangkan pengkajian terhadap potensi instabilitas dan inkompatibilitas dilakukan secara sistematis menggunakan beberapa literatur sengan kriteria yang telah ditetapkan. Hasil analisis risiko menunjukkan bahwa resep racikan mengandung amitriptilin, trifluoperazin dihidroklorida dan alprazolam memiliki risiko peracikan yang sangat tinggi. Berdasarkan penelusuran literatur sistematis, ditemukan adanya potensi ketidakstabilan dan inkompatibilitas yang mungkin terjadi yaitu penarikan lembab dan reaksi hidrolisis. Berbagai upaya teknis dapat dilakukan oleh tenaga kefarmasian untuk meningkatkan kualitas obat dan menjamin keamanannya yaitu menggunakan cangkang kapsul HPMC, menyimpan sediaan dalam wadah tertutup kedap, terhindar dari cahaya langsung pada suhu ruang dan menambahkan silika gel. Meskipun demikian, potensi instabilitas dan inkompatibilitas yang ditemukan dalam studi ini masih berdasar pada kajian pustaka, sehingga perlu dilakukan penelitian eksperimental untuk mengetahui profil stabilitas dan kompatibilitas sediaan racikan tersebut.

Keywords

peracikan obat; inkompatibilitas, instabilitas, amitriptilin, trifluoperazine dihidroklorida, alprazolam.

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References

Abbar, Jyothi C., Shekappa D. Lamani, and Sharanappa T. Nandibewoor. 2011. “Ruthenium (III) Catalyzed Oxidative Degradation of Amitriptyline-A Tricyclic Antidepressant Drug by Permanganate in Aqueous Acidic Medium.” Journal of solution chemistry 40(3): 502–520.

Abbas, Samah S., Hala E. Zaazaa, M. Abdelkawy, and Maha M. Abdelrahman. 2010. “Spectrophotometric Determination of Isopropamide Iodide and Trifluoperazine Hydrochloride in Presence of Trifluoperazine Oxidative Degradate.” Drug testing and analysis 2(4): 168–181.

Allen, L.V. 2015. “Secundum Artem: Compounding Capsule.” perrigo. http://www.perrigo.com/business/pdfs/Sec%Artem%204.4.pdf. diakses tanggal 20 Agustus 2019

Al-Tabakha, Moawia M. 2010. “HPMC Capsules: Current Status and Future Prospects.” Journal of Pharmacy & Pharmaceutical Sciences 13(3): 428–442.

Amalia, Dina Tri, and Asep Sukohar. 2014. “Rational Drug Prescription Writing.” Juke Unila 4(01).

Anonim. 2017. 18 MIMS. Jakarta: BIP.

Boodoo, Jesse M. 2010. “Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split.” American Journal of Law & Medicine 36(1): 221–48.

Cabrera, C. Gallardo, R. Goldberg De Waisbaum, and N. Sbarbati Nudelman. 2005. “Kinetic and Mechanistic Studies on the Hydrolysis and Photodegradation of Diazepam and Alprazolam.” Journal of physical organic chemistry 18(2): 156–161.

Castañeda, Beatriz, William Ortiz-Cala, Cecilia Gallardo-Cabrera, and Norma Sbarbati Nudelman. 2009. “Stability Studies of Alprazolam Tablets: Effects of Chemical Interactions with Some Excipients in Pharmaceutical Solid Preparations.” Journal of Physical Organic Chemistry 22(9): 807–814.

Chauhan, Payal P., Divya Y. Patel, and Samir K. Shah. 2017. “Optimization of Stability Indicating RP-HPLC Method for The Estimation of an Antidepressant Agents Alprazolam and Imipramine in Pure & Pharmaceutical Dosage Form.” Eurasian Journal of Analytical Chemistry 11(2): 101–13.

Chen, Yisheng. 2017. “Packaging Selection for Solid Oral Dosage Forms.” In Developing Solid Oral Dosage Forms, Elsevier, 637–651.

Chollet, John L., and Michael J. Jozwiakowski. 2012. “Quality Investigation of Hydroxyprogesterone Caproate Active Pharmaceutical Ingredient and Injection.” Drug development and industrial pharmacy 38(5): 540–549.

Depatemen Kesehatan Republik Indonesia. 2014. Farmakope Indonesia. Edisi V. Jakarta: Departemen Kesehatan Republik Indonesia.

El-Gindy, Alaa, Badr El-Zeany, Tamer Awad, and Marwan M. Shabana. 2002. “Derivative Spectrophotometric, Thin Layer Chromatographic-Densitometric and High-Performance Liquid Chromatographic Determination of Trifluoperazine Hydrochloride in Presence of Its Hydrogen Peroxide Induced-Degradation Product.” Journal of pharmaceutical and biomedical analysis 27(1–2): 9–18.

Gaur, Praveen Kumar et al. 2014. “Film Coating Technology: Past, Present and Future.” Journal of Pharmaceutical Sciences and Pharmacology 1(1): 57–67.

Gonsalves, Alexandra Rocha et al. 2010. “Identification of Alprazolam and Its Degradation Products Using LC-MS-MS.” Arkivoc 128: 141.

Gracia-Vásquez, S. L. et al. 2017. “Medications That Should Not Be Crushed.” Medicina Universitaria 19(75): 50–63.

Gudeman, Jennifer, Michael Jozwiakowski, John Chollet, and Michael Randell. 2013. “Potential Risks of Pharmacy Compounding.” Drugs in R&D 13(1): 1–8.

Gupta, Deepak et al. 2018. “Salts of Therapeutic Agents: Chemical, Physicochemical, and Biological Considerations.” Molecules 23(7): 1719.

Jackson, Mark, and Andrew Lowey. 2010. Handbook of Extemporaneous Preparation. Pharmaceutical Press. http://www.pharmpress.com/product/9780853699019/pdf/HEP_monograph.pdf (October 11, 2016).

Kementrian Kesehatan Republik Indonesia. 2016. “Peraturan Menteri Kesehatan No 72 Tahun 2016 Tentang Standar Pelayanan Kefarmasian Di Rumah Sakit.”

Merkulov, Daniela V. Šojić et al. 2018. “Photocatalytic Decomposition of Selected Biologically Active Compounds in Environmental Waters Using TiO2/Polyaniline Nanocomposites: Kinetics, Toxicity and Intermediates Assessment.” Environmental pollution 239: 457–465.

Nahata, Milap C., and Loyd V. Allen. 2008. “Extemporaneous Drug Formulations.” Clinical Therapeutics 30(11): 2112–2119.

Rani, A. Prameela, K. E. Pravallika, P. Ravi, and O. Sasivardhan. 2017. “Development and Validation of Stability Indicating RP-UPLC Method for the Simultaneous Estimation of Chlordiazepoxide and Amitriptyline Hydrochloride in Bulk and Tablet Dosage Forms.” International Journal of ChemTech Research 10(9): 467–76.

Royal Pharmaceutical Society. 2011. “Pharmaceutical Issues When Crushing, Opening or Splitting Oral Dosage Forms.” https://www.rpharms.com/Portals/0/RPS%20document%20library/Open%20access/Support/toolkit/pharmaceuticalissuesdosageforms-%282%29.pdf. diakses tanggal 20 Agustus 2019

Shaikh, S., and V. Jain. 2018. “Development and Validation of Novel RPHPLC Method for Simultaneous Estimation of Gabapentine and Amitriptyline Hydrochloride in Bulk and Pharmacetical Dosage Forms.” International Journal of Applied Pharmaceutics 10(2): 97–104.

Sharma, K., S.S. Agrawal, and M. Gupta. 2012. “Development and Validation of UV Spectrophotometric Method for the Estimation of Curcumin in Bulk Drug and Pharmaceutical Dosage Forms.” International Journal of Drug Development & Research 4(2): 375–80.

Shetti, P., and A. Venkatachalam. 2010. “Stability Indicating HPLC Method for Simultaneous Quantification of Trihexyphenidyl Hydrochloride, Trifluoperazine Hydrochloride and Chlorpromazine Hydrochloride from Tablet Formulation.” Journal of Chemistry 7(S1): S299–S313.

Thanacoody, HK Ruben, and Simon HL Thomas. 2005. “Tricyclic Antidepressant Poisoning.” Toxicological reviews 24(3): 205–214.

Thong, Min Yew, Yady J. Manrique, and Kathryn J. Steadman. 2018. “Drug Loss While Crushing Tablets: Comparison of 24 Tablet Crushing Devices.” PLOS ONE 13(3): e0193683.

Trawiński, Jakub, and Robert Skibiński. 2017. “Studies on Photodegradation Process of Psychotropic Drugs: A Review.” Environmental Science and Pollution Research 24(2): 1152–1199.

Wiedyaningsih, Chairun, and DR Sri Suryawati. 2013. “Faktor Pendorong Peresepan Racikan Untuk Pasien Anak Rawat Jalan.” PhD Thesis. Universitas Gadjah Mada.

DOI: https://doi.org/10.20961/jpscr.v4i2.34187

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