Formulasi oral disintegrating film dan uji disolusi terbanding sildenafil sitrat

Andreas, Christian Jose (2025) Formulasi oral disintegrating film dan uji disolusi terbanding sildenafil sitrat. Bachelor thesis, Universitas Pelita Harapan.

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Abstract

Sildenafil sitrat merupakan obat untuk mengatasi Disfungsi Ereksi (DE) yang merupakan zat inhibitor kuat yang selektif dari cGMP spesifik fosfodiesterase tipe 5 (PDE5) pada korpus kavernosum, PDE5 ini akan bertanggung jawab pada degradasi cGMP. Adanya kondisi yang mendukung terjadinya DE seperti diabetes, penyakit atau gangguan jantung serta kondisi lainnya seperti faktor psikologis. Pembuatan sediaan film lapis tipis dapat mendukung kepatuhan pasien dalam menjalankan pengobatannya, pembuatan sediaan baru akan membutuhkan studi terhadap bioekivalensinya terhadap obat yang sudah ada sebelumnya. Pembuatan sediaan film lapis tipis akan menggunakan polimer pullulan, agen penutup rasa MgO dan NaOH serta plastisizer PEG 400 dan Gliserin dengan tingkat konsentrasi yang berbeda-beda dan dipilih formula F6 sebagai formula terbaik. Pengujian uji disolusi dilakukan dengan membandingkan antara dua sediaan yaitu ODF Sildenafil dan juga Obat komparatornya. Sediaan film lapis tipis (ODF) memiliki nilai f₂ 66,79-83,12, sediaan memiliki sifat bioekivalensi dengan obat komparator yang sudah ada yaitu tablet Viagra 50 mg. / Sildenafil citrate is a medication used to treat Erectile Dysfunction (ED) and acts as a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP)- specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum. PDE5 is responsible for the degradation of cGMP. Several conditions contribute to the development of ED, including diabetes, cardiovascular diseases, and psychological factors. The formulation of orally dissolving films (ODF) can enhance patient adherence to treatment. The development of a new dosage form requires a bioequivalence study in comparison with an existing reference product. The ODF formulation utilizes pullulan as the polymer, MgO and NaOH as taste-masking agents, and PEG 400 and glycerin as plasticizers with different concentrations on each excipients and so formula f6 was chosen to be the best. A dissolution test was conducted to compare the ODF Sildenafil with its comparator drug. The ODF demonstrated an f₂ value ranging from 66.79 to 83.12, indicating bioequivalence with the existing reference product Viagra tablet 50 mg.
Item Type: Thesis (Bachelor)
Creators:
Creators
NIM
Email
ORCID
Andreas, Christian Jose
NIM01038210007
Cjosenad01@gmail.com
UNSPECIFIED
Contributors:
Contribution
Contributors
NIDN/NIDK
Email
Contributor
Rosa, Dela
NIDN20070046
dela.rosa@uph.edu
Uncontrolled Keywords: oral disintegrating film; sildenafil sitrat; uji disolusi terbanding
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: University Subject > Current > Faculty/School - UPH Karawaci > Faculty of Health Sciences > Pharmacy
Current > Faculty/School - UPH Karawaci > Faculty of Health Sciences > Pharmacy
Depositing User: CHRISTIAN JOSE ANDREAS
Date Deposited: 23 Jul 2025 09:02
Last Modified: 23 Jul 2025 09:02
URI: http://repository.uph.edu/id/eprint/69825

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