eprintid: 20855
rev_number: 8
eprint_status: archive
userid: 3858
dir: disk0/00/02/08/55
datestamp: 2023-02-11 03:21:02
lastmod: 2023-02-11 03:21:02
status_changed: 2023-02-11 03:21:02
type: thesis
metadata_visibility: show
creators_name: M. Dandi, M. Dandi
creators_name: Nining, Nining
creators_name: Amalia, Anisa
title: OPTIMASI FORMULA ORAL DISSOLVING FILM CETIRIZIN HCl
BERBASIS MALTODEXTRIN-SORGUM SEBAGAI FILM FORMING DAN
GLISEROL SEBAGAI PLASTICIZER
ispublished: pub
subjects: R
subjects: RS
divisions: 48201
abstract: Oral Dissolving Film (ODF) merupakan sediaan alternatif yang dapat mengatasi
permasalahan bagi pasien pediatri dan geriatri yang mengalami kesulitan menelan.
Komponen dalam sediaan ODF yang paling berpengaruh terhadap sifat fisik
sediaan film adalah pembentuk film dan plasticizer. Pati termodifikasi merupakan
contoh pembentuk film yang baik dan eksipien yang dapat digunakan sebagai
plasticizer dalam sediaan ODF yaitu gliserol. Penelitian ini bertujuan untuk
mendapatkan formula ODF yang optimal digunakan Response Surface
Methodology (RSM) dengan pola Central Composite Design (CCD). Polimer dan
plasticizer sebagai faktor dimasukan dalam rancangan CCD dengan rentang
masing-masing 2-6 % dan 3-10 % dilakukan pengujian terhadap respon berupa
tensile strenght, elongation dan desintegration time. Rancangan CCD
menghasilkan 14 percobaan, hasil rancangan kondisi optimal memiliki prediksi
dengan respon tensile strength 1,495 Mpa, hasil observasi 1,50 Mpa dengan
persentase error 0,33%. Hasil prediksi elongation 104 %, observasi menghasilkan
104,26% dan persentase error sebesar 0,33%. Prediksi pada disintegration time
selama 83 sec, hasil observasi memiliki waktu 82,95 sec dan persentase error
sebesar 0,06%. Hasil formula optimal yang didapatkan sesuai dengan prediksi
RSM yaitu maltodextrin-sorgum sebesar 3,56 % dan gliserol sebesar 10,00 %,
sehingga dapat dinyatakan sediaan ODF memenuhi syarat karakteristik
pembentuk film yang baik.
Kata Kunci: Cetirizine HCl, Gliserol, Maltodextrin-Sorgum, Oral Dissolving
Film, Response Surface Methodology (RSM).
date: 2021
date_type: completed
full_text_status: public
institution: Universitas Muhammadiyah Prof. DR. HAMKA
department: Fakultas Farmasi dan Sains
thesis_type: bachelor
thesis_name: bphil
referencetext: Aberg, J., Lacy, C., Amstrong, L., Goldman, M., & Lance, L. 2009. Drug
Information Handbook17th Edition. American Pharmacist Association.
Afifah. (2018). “Pengaruh Kombinasi Plasticizer terhadap Karakteristik Edible
Film dari Karagenan dan Lilin Lebah.” Biopropal Industri, 9(No 1), 49–60.
http://ejournal.kemenperin.go.id/biopropal/article/view/3765
Agoes, G. 2012. Sediaan Farmasi Padat Edisi 6. ITB Press.Bandung. 366-368
Almeida, M., Erthal, R., Padua, E., Silveira, L., & Am, L. (2008). Response
Surface Methodology ( RSM ) As A Tool For Optimization In Analytical
Chemistry. Talanta, 76, 965–977.
Borges, A. F., Silva, C., Coelho, J. F. J., & Simões, S. (2015). Oral Films: Current
Status and Future Perspectives: I-Galenical Development and Quality
Attributes. Journal of Controlled Release, 206, 1–19.
Chapdelaine, A., Daniel, Z., & Michael, D. 2009. Improved Edible Film
Formulations Containing Maltodextrin. European Patent Specification, 1, 1–
12.
Cilurzo, Francesco., Cupone, Irma E., Minghetti, Paola., Selmin, Francesca.,
&Montanari, Luisa. 2008. Fast Dissolving Films Made of Maltodextrins.
European Journal of Pharmaceutics and Biopharmaceutics, 70, 895–900
Depkes RI. 2008. Farmakope Herbal Indonesia, Departemen Kesehatan Republik
Indonesia, Jakarta.
Dixit, R. P., & Puthli, S. P. 2009. Oral Strip Technology : Overview And Future
Potential. Journal of Controlled Release, 139(2), 94–107.
Elmeshad, A. N., & El Hagrasy, A. S. 2011. Characterization and Optimization of
Orodispersible Mosapride Film Formulations. AAPS PharmSciTech, 12(4),
1384-1392
Fahrullah, F., Radiati, L. E., Purwadi, P., & Rosyidi, D. 2020. The Effect of
Different Plasticizers on the Characteristics of Whey Composite Edible Film.
Jurnal Ilmu Dan Teknologi Hasil Ternak, 15(1), 31–37.
Fu, M. C., Price, C. C., & Zhu, J. 2015. Handbook of Simulation
OptimizationVolume 216. Springer.
Haryani, K., & Hargono. 2017. Modifikasi Pati Sorgum Menjadi
MaltodekstrinMenggunakan Enzim Alfa Amilase,Glukoamilase, dan Pepsin.
Prosiding SNST Ke-8, 88–92.
Hoffmann, E. M., Breitenbach, A., & Breitkreutz, J. 2011. Advances in
Orodispersible Films For Drug Delivery. Expert Opinion on Drug Delivery,
8(3), 299–316. 
Honary, S., & Orafai, H. (2002). The Effect of Different Plasticizer Molecular
Weights and Concentrations on Mechanical and Thermomechanical
Properties of Free Films. Drug Development and Industrial Pharmacy, 28(6),
711–715.
Irfan, M., Rabel, S., Bukhtar, Q., Qadir, M. I., Jabeen, F., & Khan, A. 2015.
Orally Disintegrating Films : A Modern Expansion in Drug Delivery System.
Saudi Pharmaceutical Journal, 24(5), 537–546.
Jennings, C. L., Dziubla, T. D., & Puleo, D. A. 2016. Combined Effects Of Drugs
And Plasticizers On The Properties Of Drug Delivery Films. Journal of
Bioactive and Compatible Polymers, 31(4), 323–333.
Karki, S., Kim, H., Na, S., Shin, D., Jo, K., & Lee, J. 2016. hin Films As An
Emerging Platform For Drug Delivery. Asian Journal Of Pharmaceutical
Sciences,11, 559–574.
Kristianingrum, S. (2016). Gambar 22. Model ikatan kimia. Handout Spektroskopi
Infra Merah., Universitas Negeri Yogyakarta.
Kunarto, B., & Sani, E. Y. 2017. Pembuatan Maltodekstrin Dari Pati Biji Durian
(Durio Zibethinus Murr.) Menggunakan Enzim Α Amilase. Prosiding SNST
Ke-8, 110–114.
Kusumayanti, H., Handayani, N. A., & Santosa, H. 2015. Swelling Power and
Water Solubility of Cassava and Sweet Potatoes Flour. Procedia
Environmental Sciences, 23, 164–167.
Laga, A., Dirpan, A., & Anshari, A. A. (2018). Pengaruh Konsentrasi Substrat
Pada Pembuatan Maltodekstrin Dari Substrat Pati Sagu. Canrea Journal, 23–
30.
Lenth, R. V. 2012. Response-Surface Methods in R , Using rsm. The University of
Lowa
Mahmood, S. Z., Sabry, H. S., Yousif, N. Z., & Salman, Z. D. 2018. Optimization
And Evaluation Of Chlorpheniramine Maleate Oral Strip For Pediatric Use.
Asian Journal of Pharmaceutical and Clinical Research, 11(12), 548–554.
Mishra, A., & Pathak, A. K. (2017). Plasticizers: A Vital Excipient in Novel
Pharmaceutical Formulations. Current Research in Pharmaceutical Sciences,
7(1), 01–10.
Ningsih, D. R., Asnani, A., & Fatoni, A. 2010. Pembuatan Dekstrin Dari Pati Ubi
Kayu Menggunakan Enzim Amilase Dari Azospirillum Sp. Jg dan
Karakterisasinya. Molekul, 5(1), 15–21.
Nurfida, A., & Puspitawati, I. N. 2010. Pembuatan Maltodekstrin Dengan Proses
Hidrolisa Parsial Pati Singkong Menggunakan Enzim α- Amilase.Jurusan
Teknik Kimia Fakultas Teknik. Universitas Diponegoro. 1–8.
Pandey, G. S., Kumar, R., Sharma, R., Singh, Y., & Teotia, U. V. 2014. Effects of
Maltodextrin and Glycerin on Mechanical Properties of Oral Fast Dissolving
Film of Salbutamol Sulphate. International Journal Of Advances In
Pharmacy, Biology And Chemistry, Vol. 3(1), 199–209.
Paczkowska, M., Mizera, M., Lewandowska, K., Kozak, M., Miklaszewski, A., &
Cielecka-Piontek, J. (2018). Effects of inclusion of cetirizine hydrochloride
in β-cyclodextrin. In Journal of Inclusion Phenomena and Macrocyclic
Chemistry (Vol. 91, Issues 3–4, pp. 150–151).
Panraksa, P., Jantrawut, P., Tipduangta, P., & Jantanasakulwong, K. 2020.
Formulation of Orally Disintegrating Films As An Amorphous Solid
Solution of A Poorly Water-Soluble Drug. Membranes, 10(12), 1–17.
Pavia, D. L., Lampman, G. M., Kriz, G. S., & Vyvyan, J. R. (2009). Introduction
to SpectroscopyFourth Edition. Brooks/Cole cengange leraning. 1-656
Quazi et al. (2020). A review on mouth dissolving films. Indian Drugs, 7(3), 232–
238.
Qussi, B., & Suess, W. G. 2006. The Influence Of Different Plasticizers And
Polymers On The Mechanical And Thermal Properties, Porosity And Drug
Permeability Of Free Shellac Films. Drug Development and Industrial
Pharmacy, 32(4), 403–412.
Rabek, C. L., Stelle, R. Van, Dziubla, T. D.,& Puleo, D. A. 2015. The Effect Of
Plasticizers On The Erosion And Mechanical Properties Of Polymeric Films.
28(5), 779–789.
Rosmimik, Richana, N., Lestari, P., & Damardjati, D. S. 2001. Studi Penambahan
Ion Kalsium terhadap Aktivitas dan Stabilitas a-Amilase (Bacillus
stearothermophilus TII). Jumal MikrobioIogi Indonesia, 6(I), 12–14.
Rowe, R. C., Sheskey, P. J., & Owen, S. C. (2006). Handbook of Pharmaceutical
ExcipientsFifth Edit. Pharmaceutical Press.1-918
Saavedra, Z., Leyva-porras, C., & Araujo-díaz, S. B. 2015. Technological
Application of Maltodextrins According to the Degree of Polymerization.
Molucules, 20, 21067–21081.
Sari, D. I., Fitriana, Mi., Mulyadi, R. R., & Hidayati, L. 2017. Karakterisasi dan
Uji Stabilitas Fisik Sediaan Edible Film Ekstrak Etanol Kulit Batang Kasturi
(Mangifera casturi Kosterm) Berbasis Gelatin. Prosiding Seminar
Kefarmasian Dan Presentasi Ilmiah, 8–17.
Shah, U., Naqash, F., Gani, A., & Masoodi, F. A. 2016. Art and Science behind
Modified Starch Edible Films and Coatings: A Review. Comprehensive
Reviews in Food Science and Food Safety, 15(3), 568–580.
Sharma, D., Kaur, D., Verma, S., Singh, D., Singh, M., & Singh, G. (2015). Fast
Dissolving Oral Films Technology: A Recent Trend for An Innovative Oral
Drug Delivery System. International Journal of Drug Delivery Technology, 
7(2), 60–75.
Singh, H., Kaur, M., & Verma, H. 2013. Optimization and Evaluation of
Desloratadine Oral Strip: An Innovation in Paediatric Medication. The
Scientific World Journal, 2013, 1–9.
Sri, S. J., Krishna, K. S. M., Kusuma, D., & Shankar, C. U. 2018. Formulation
and in-Vitro Evaluation of Benazepril Mouth Dissolving Films. Indo
American Journal of Pharmaceutical Sciences, 5(1), 552–560.
Sweetman, S. . (2009). Martindale 36th : The Complete Drug Reference.
Pharmaceutival Press.1-3694
Tiwari, S., Srivastava, R., Singh, C., Shukla, K., Singh, R., Singh, P., Singh, R.,
Singh, N., & Sharma, R. (2015). Amylases: an Overview With Special
Reference To Alpha Amylase. Journal of Global Biosciences, 4(1), 1886–
1901.
Triyono, A. 2007. Peningkatan Fungsional Pati dari Ubi Jalar (Ipomoea batatas
L.) dengan Enzim a-Amilase (Bacillus subtilis) Sebagai Bahan Subtitusi
Pengolahan Pangan. J Sains MIPA, 13(1), 60–66.
Wongphan, P., & Harnkarnsujarit, N. 2020. Characterization of Starch, Agar and
Maltodextrin Blends for Controlled Dissolution of Edible Films.
International Journal of Biological Macromolecules, 156, 80–93.
Zadha, H. A., & Raharjo, W. 2013. Isolasi Dekstrin Dari Pati Sorgum Dengan
Proses Hidrolisa Parsial Menggunakan Enzim Α -Amilase. Jurnal Teknologi
Kimia dan Industri.2(2), 116–121.
Zubair, A., & Padjadjaran, U. (2018). SORGUM - Tanaman Multi Manfaat.
UNPAD Press. Bandung. 1-77.
citation:   M. Dandi, M. Dandi dan Nining, Nining dan Amalia, Anisa  (2021) OPTIMASI FORMULA ORAL DISSOLVING FILM CETIRIZIN HCl BERBASIS MALTODEXTRIN-SORGUM SEBAGAI FILM FORMING DAN GLISEROL SEBAGAI PLASTICIZER.  Bachelor thesis, Universitas Muhammadiyah Prof. DR. HAMKA.   
document_url: http://repository.uhamka.ac.id/id/eprint/20855/1/FS03-210243.pdf