xiii

EVALUASI MUTU FISIK , UJI DISINTEGRASI DAN UJI DISOLUSI

TERBANDING TABLET SALUT ENTERIK KETOPROFEN GENERIK

DAN GENERIK BERMEREK

INTISARI

Ketoprofen merupakan salah satu obat anti inflamasi non steroid (AINS)

yang memiliki kelarutan yang rendah dalam air dan memiliki permeabilitas

tinggi dalam usus sehingga dikategorikan dalam Biopharmaceutical

ClassificationSystem (BCS) kelas II. Obat ini tersedia dipasaran dalam berbagai

sediaan generik dan bermerek, sehingga memungkinkan terjadi perbedaan

formulasi dan metode fabrikasi. Penelitian ini bertujuan untuk mengevaluasi

kesesuaian mutu fisik, kecepatan disintegrasi dan disolusi tablet salut enterik

ketoprofen generik maupun generik bermerek yang beredar dengan standar yang

telah ditetapkan. Penelitian ini menggunakan 5 produk ketoprofen 100 mg yang

beredar dipasaran. Uji mutu fisik yang meliputi uji keseragaman bobot, diameter

dan ketebalan serta uji disintegrasi dilakukan sesuai prosedur yang tertera dalam

Farmakope Indonesia edisi III dan IV. Uji disintegrasi dilakukan dalam medium

HCl 0,1N dan larutan dapar fosfat pH 6,8 pada suhu 370 2

0C. Uji disolusi

menggunakan alat disolusi tipe 2 (dayung), kecepatan rotasi 50 rpm dalam 900

ml cairan simulasi usus pH 7,4 , dengan suhu pada 37 0,5 C selama 60 menit.

Hasil penelitian menunjukkan bahwa uji mutu fisik dan uji disintegrasi secara

keseluruhan memenuhi persyaratan dengan waktu hancur dalam larutan dapar

fosfat pH 6,8 berkisar 12-18,77 menit (tidak lebih dari 2 jam). Persentase

terdisolusi pada menit ke 45 (Q45) berturut-turut sebagai berikut : A= 101,68% ,

B= 104,97%, C= 95,03%, D= 91,22%, E= 100,83 %. Hasil disolusi tersebut

menunjukkan bahwa tablet ketoprofen telah memenuhi persyaratan disolusi

USP30 NF-25 (tidak kurang dari 75%). Oleh karena itu dapat disimpulkan

bahwa 5 tablet salut enterik yang beredar dipasaran telah memenuhi standar.

Kata kunci : Ketoprofen, tablet, obat generik, BCS II, disolusi, Uji disolusi

terbanding

xiv

PHYSICAL QUALITY EVALUATION, DISINTEGRATION, AND

COMPARATIVE DISSOLUTION TEST OF GENERIC AND BRANDED

GENERIC KETOPROFEN ENTERIC COATED TABLETS

ABSTRACT

Ketoprofen is Non-Steroidal Antiinflamatory Drug (NSAID), which has

low solubility in the water but high permeability in the intestine, thus ketoprofen

is categorized in BCS class II. Ketoprofen is available in generic and branded

generic products that might have differences in formulation and production

method. This study was aimed to evaluate physical quality, disintegration and

dissolution rates of generic and branded generic ketoprofen tablets in market. This

study used 5 enteric coated ketoprofen products, which consists of one generic

(code : A) and four branded generic products (Code : B,C,D,E). Physical quality

tests were weight uniformity, diameter, thickness and disintegration tests

according to the procedures of Indonesian Pharmacopoeia edition III and IV.

Disintegration tests were performed using 0.1 N HCl and phosphate buffer

solution pH 6.8 at 370 2

0C. Dissolution tests were performed using a dissolution

tester apparatus type 2 (paddle), speed rotsation of 50 rpm on 900 ml of

simulation intestinal fluid without enzyme (pH 7.4), at 37 0.5 C in 60 minutes.

The results of the physical quality and disintegration tests were compared with 3rd

and 4th

edition Indonesian Pharmacopoeia, while the dissolution tests were

compared with USP 30 - NF25. The results showed that all physical quality tests

and disintegration tests have fulfilled the requirements. The results of

disintegration tests at phosphate buffer pH 6.8 is 12-18,7 minutes (less than 2

hours). Drug release of all products at 45th

minute (Q45) were 101,68%,104,97%,

95,03%, 91,22%, 100,83% respectively, which complied with the USP in vitro

dissolution specification. The results showed that dissolution test meet

requirement of dissolution in USP30 NF-25 (not less than 75%). It indicated that

five ketoprofen tablets that available in market have met the requirements.

Keywords : ketoprofen, tablet, generic, BCS II, dissolution, comparative

dissolution test