Analisis pengendalian kualitas obat sediaan kaplet salut selaput profenal melalui penerapan metode statistical process control di PT. Yarindo Farmatama

PUSPITA, Oktavia Eka, Prof. Dr. Achmad Fudholi, DEA., Apt

2010 | Tesis | S2 Ilmu Farmasi

Proses produksi sediaan obat kaplet salut selaput merupakan multi-steps process, yaitu penimbangan, pencampuran, granulasi, pengeringan, pengempaan, penyalutan, dan pengemasan. Setiap proses produksi dipengaruhi oleh variasi alamiah (natural variation) dan variasi buatan (assignable variation) yang berpengaruh terhadap konsistensi dan tercapainya spesifikasi kualitas output. Adanya variasi buatan dalam sebuah proses harus segera diidentifikasi dan dieliminasi untuk mencegah masalah kualitas output dan mempertahankan proses produksi berada dalam status terkendali atau stabil serta dapat memenuhi spesifikasi kualitas yang ditetapkan. Metode yang dapat diterapkan adalah Statistical Process Control (SPC) dengan menggunakan alat bagan kendali (control chart). Penelitian ini dilakukan terhadap proses produksi kaplet salut selaput Profenal® di PT.Yarindo Farmatama, yaitu terbatas pada tahap proses pengempaan kaplet inti dan tahap proses penyalutan. Penelitian ini bertujuan untuk menganalisis tahap proses produksi pengempaan kaplet inti dan penyalutan kaplet salut selaput Profenal® stabil (in-control) atau tidak (out-of control), dan mengukur process capability tahapan proses tersebut. Penelusuran 20 dokumen batch record terakhir secara berurutan selama periode 2009 dilakukan untuk memperoleh data kuantitatif hasil pengukuran karakteristik kualitas kaplet yaitu keseragaman bobot, kekerasan, ketebalan, kerapuhan, waktu hancur, disolusi, dan kadar zat aktif kaplet untuk kemudian dianalisis menggunakan metode SPC dengan alat bagan kendali (control chart), dan pengukuran process capability menggunakan indeks Cpk. Hasil analisis pada penelitian ini adalah sebagai berikut: pada tahap proses pengempaan kaplet inti bagan kendali karakteristik kualitas kaplet yang menunjukkan secara statistik in-control adalah: keseragaman bobot, sedangkan bagan kendali yang menunjukkan secara statistik out-of control adalah kekerasan, ketebalan, kerapuhan, waktu hancur, disolusi Parasetamol dan Ibuprofen. Pada tahap proses penyalutan bagan kendali karakteristik kualitas kaplet yang menunjukkan secara statistik in-control adalah waktu hancur, disolusi Parasetamol, dan kadar Parasetamol, sedangkan bagan kendali yang menunjukkan secara statistik out-of control adalah keseragaman bobot, kekerasan, disolusi Ibuprofen, dan kadar Ibuprofen. Cpk proses dilihat dari aspek karakteristik kualitas keseragaman bobot kaplet inti: 1,375, waktu hancur kaplet salut selaput Profenal®: 1,770, disolusi Parasetamol kaplet salut selaput Profenal®: 1,841, dan kadar Parasetamol kaplet salut selaput Profenal®: Cpk 1,719.

Manufacturing of film-coated caplet dosage form is a multi- steps process, including weighing, blending, granulating, drying, compression, coating, and packaging. Every manufacturing process is influenced by natural variation and assignable variation which interfering consistency and attainment of output quality specification. The presence of assignable variation in a process has to be identified and eliminated to prevent quality problem and to maintain the process to be in stable and capable of meeting pre-determined quality specifications. A method can be implemented for this purpose is Statistical Process Control (SPC) using control chart tool. This research was conducted upon manufacturing process of Profenal® film coated caplet at PT.Yarindo Farmatama. This research was limited for core caplet compression step and film coating step instead of entire production process. The purposes of this research were analyzing core caplet compression process and coating process whether in state of control or out-of control and measuring process capability of those processes. Investigation of 20 latest consecutive batch record documents within 2009 period was conducted in collecting quantitative data measurement of caplet quality characteristics including weight uniformity, hardness, thickness, friability, disintegration, dissolution, and assay of drug substance of Profenal® film coated caplet. Those data were analyzed using control chart SPC method and process capability was measured by Cpk index. The results of the analysis as follow: control chart from caplet core compression step which indicate statistically in-control was caplet weight uniformity, while control chart that indicate statistically out of-control were hardness, thickness, friability, disintegration time, and Paracetamol and Ibuprophen dissolution. Control chart from film coating step which indicate statistically in-control were disintegration time, Paracetamol dissolution, and Parasetamol content, while control chart that indicate statistically out of-control were weight uniformity, hardness, Ibuprophen dissolution, and Ibuprofen content. The process capability index, Cpk, based on the aspect of quality characteristics as follow: core caplet weight uniformity: 1,375, Profenal® film-coated caplet disintegration time: 1,770, Paracetamol Profenal® film-coated caplet dissolution: 1,841, and Paracetamol content of Profenal®film-coated caplet: Cpk 1,719.

Kata Kunci : Natural variation,Assignable variation,Statistical process control,Kaplet salut selaput Profenal, natural variation, assignable variation, Statistical Process Control, Profenal® film coated caplet