suspension fardas s1 2013
TRANSCRIPT
Suspensions
zulfiayuS1 Farmasi UNG mei 2013
Definisi
• Sediaan yang mengandung bahan obat padatdalam bentuk halus dan tidak larut, terdispersidlam cairan pembawa
• Sediaan heterogen yg terdiri atas 2 fase, yitufase terdispersi atau fase kontinue atau faseluar yg umumnya cairan atau setengah padat;dan fase terdispersi atau fase luar yg terdiriatas bahan-bahan yang tidak larut
• Sediaan yang mengandung bahan obat padatdalam bentuk halus dan tidak larut, terdispersidlam cairan pembawa
• Sediaan heterogen yg terdiri atas 2 fase, yitufase terdispersi atau fase kontinue atau faseluar yg umumnya cairan atau setengah padat;dan fase terdispersi atau fase luar yg terdiriatas bahan-bahan yang tidak larut
Definition
• NonHomogenous substance• Insoluble finely divided solid is dispersed
uniformly in a liquid dispersion medium• Thermoynamically unstable
Acceptable shelf life at room temp.
• NonHomogenous substance• Insoluble finely divided solid is dispersed
uniformly in a liquid dispersion medium• Thermoynamically unstable
Acceptable shelf life at room temp.
Component
• Internal (globules)/disperse/discontinousphaseOralhigh amounts of dispersed solid.parenteralless than 5% solids.
• External /discontinous phaseliquid / semi solid
• Wetting Agent• Suspending Agent
• Internal (globules)/disperse/discontinousphaseOralhigh amounts of dispersed solid.parenteralless than 5% solids.
• External /discontinous phaseliquid / semi solid
• Wetting Agent• Suspending Agent
Size of particle
Coarse suspension: greater than ~1 μmColloidal suspension : below 1 μmWhen the particles constituting the internalphase of the suspension are therapeuticallyactive, the suspension is known aspharmaceutical suspension.
Coarse suspension: greater than ~1 μmColloidal suspension : below 1 μmWhen the particles constituting the internalphase of the suspension are therapeuticallyactive, the suspension is known aspharmaceutical suspension.
Aplication and Utility
Why suspension used?– The drug is insoluble in the delivery vehicle.– To mask the bitter taste of the drug.– To increase drug stability.– To achieve controlled/sustained drug release.
Why suspension used?– The drug is insoluble in the delivery vehicle.– To mask the bitter taste of the drug.– To increase drug stability.– To achieve controlled/sustained drug release.
Aplication and UtilityAplication• Oral medicinesantacid suspensions, ex :oral antibacterial suspensions,Oral
analgesic suspensions,Oral anthelmintic suspension,Oral anticonvulsantsuspensions,Oral antifungal suspensions,Dry antibiotic powders for oralsuspensions
• Parenteral products, ex :Intramuscular antidiarrheal suspensions,Intravenousanticancer suspensions, Intramuscular contraceptive suspensions
• Topical products, e.g. high protection-factor sunscreens• Metered-dose aerosol inhalation products• Suppositories• Film-coating of tablets• Sugar-coating of tablets• Manufacture of hard gelatin capsule shells and fills• Manufacture of soft gelatin capsule fills and shells• Granulating suspensions (“slurries”) used in the wet granulation of powders for
granule, tablet or capsule manufacturepical suspensions,oral suspensions
Aplication• Oral medicinesantacid suspensions, ex :oral antibacterial suspensions,Oral
analgesic suspensions,Oral anthelmintic suspension,Oral anticonvulsantsuspensions,Oral antifungal suspensions,Dry antibiotic powders for oralsuspensions
• Parenteral products, ex :Intramuscular antidiarrheal suspensions,Intravenousanticancer suspensions, Intramuscular contraceptive suspensions
• Topical products, e.g. high protection-factor sunscreens• Metered-dose aerosol inhalation products• Suppositories• Film-coating of tablets• Sugar-coating of tablets• Manufacture of hard gelatin capsule shells and fills• Manufacture of soft gelatin capsule fills and shells• Granulating suspensions (“slurries”) used in the wet granulation of powders for
granule, tablet or capsule manufacturepical suspensions,oral suspensions
Suspensions are also used in the allied fields ofcosmetics, veterinary medicine,pest control,including domestic, industrial and agriculturalapplications, and other industrial
Suspensions are also used in the allied fields ofcosmetics, veterinary medicine,pest control,including domestic, industrial and agriculturalapplications, and other industrial
Ideal Suspension
The suspension must be :• physically stable (no appreciable settling) for a
sufficient time,• chemically stable over the required time (shelf-life),• possess a viscosity that allows it to be used for its
intended purpose,• be easily reconstituted by shaking,• and be acceptable in use to the patient, care-giver or
other user.
The suspension must be :• physically stable (no appreciable settling) for a
sufficient time,• chemically stable over the required time (shelf-life),• possess a viscosity that allows it to be used for its
intended purpose,• be easily reconstituted by shaking,• and be acceptable in use to the patient, care-giver or
other user.
Some desirable attributes of a suspension are described by Bhargava et al.(1996).1. It should be safe, effective, stable, and pharmaceutically elegant during the
shelf life of the product.2. The drug should not have a quick sedimentation rate. Furthermore, it
should resuspend easily upon shaking and it must not cake.3. Physical attributes such as particle size, particle size distribution, viscosity
should remain fairly uniform throughout the shelf life of the product.4. Its viscosity must promote free and uniform flow from the container. The
product must have appropriate substantivity that it spreads freely over theaffected area.
5. Resuspension should produce a homogeneous mix of drug particles suchthat there is a content uniformity with each dose.
Some desirable attributes of a suspension are described by Bhargava et al.(1996).1. It should be safe, effective, stable, and pharmaceutically elegant during the
shelf life of the product.2. The drug should not have a quick sedimentation rate. Furthermore, it
should resuspend easily upon shaking and it must not cake.3. Physical attributes such as particle size, particle size distribution, viscosity
should remain fairly uniform throughout the shelf life of the product.4. Its viscosity must promote free and uniform flow from the container. The
product must have appropriate substantivity that it spreads freely over theaffected area.
5. Resuspension should produce a homogeneous mix of drug particles suchthat there is a content uniformity with each dose.
Type of Suspension
Type of particle solid• Floculated suspension• Defloculated suspension
Size of particle :• Colloidal suspension• Coarse suspension
Type of particle solid• Floculated suspension• Defloculated suspension
Size of particle :• Colloidal suspension• Coarse suspension
Type of suspension
Route :• Oral• Non oral
Flocculated Suspension
Open-network suspension aggregate
Deflocculated Suspensionc
Dispersed particles Closed suspensionaggregate
Wetting/Pembasah
• Bahan Pembasah sangat penting padasuspensi
• Kemudahan terbasahinya serbuk tergantungdari besarnya sudut kontak sudut yangterbentuk antara serbuk dgn permukaancairan
• Bahan Pembasah sangat penting padasuspensi
• Kemudahan terbasahinya serbuk tergantungdari besarnya sudut kontak sudut yangterbentuk antara serbuk dgn permukaancairan
Sudut kontak
• Sudut kontak ± 90˚mengambang/terapungdi atas cairan
• Sudut kontak ˂ 90˚menyelup/mengambang di bawah cairan
• Tidak ada sudut kontak serbuk tenggelam• Serbuk dengan sudut kontak besar sukar
dibasahi oleh air hidrofob
• Sudut kontak ± 90˚mengambang/terapungdi atas cairan
• Sudut kontak ˂ 90˚menyelup/mengambang di bawah cairan
• Tidak ada sudut kontak serbuk tenggelam• Serbuk dengan sudut kontak besar sukar
dibasahi oleh air hidrofob
• Untuk menurunkan tegangan antar mukaantara partikel padat & cairan pembawatambahkan wetting agent atau surfactan
• Co : gliserin, propilenglikol, larutan gom
• Untuk menurunkan tegangan antar mukaantara partikel padat & cairan pembawatambahkan wetting agent atau surfactan
• Co : gliserin, propilenglikol, larutan gom
Pembuatan suspensi
• Menggunakan pensuspensi PGS (PuvisGummosus)
• Banyaknya PGS tidak tergantung padabanyaknya serbuk tegantung padabanyknya cairan
• 2% u bahan yg berkhasiat keras, 1% lainnyadari jumlah cairan
• Menggunakan pensuspensi PGS (PuvisGummosus)
• Banyaknya PGS tidak tergantung padabanyaknya serbuk tegantung padabanyknya cairan
• 2% u bahan yg berkhasiat keras, 1% lainnyadari jumlah cairan
Cara membuat
• Bahan yang tidak larut dicampur/digerus dgnPGS di dalam lumpang, kemdian tambahkanair sebanyak 7x PGS ygn dipakai
• Jika zat padat dalam campuran cukup banyak,air bisa lebih
• Bahan yang tidak larut dicampur/digerus dgnPGS di dalam lumpang, kemdian tambahkanair sebanyak 7x PGS ygn dipakai
• Jika zat padat dalam campuran cukup banyak,air bisa lebih
Pengecualian
• Mg oksida, Mg subkarbonas serbuk ygringan dapat disuspensikan tnpa zattambahan
• Carbo adsorbens, carbo ligni (obat diare) tidaktambaha PGS (lendir)mengurangi dayakerjanya
• Mg oksida, Mg subkarbonas serbuk ygringan dapat disuspensikan tnpa zattambahan
• Carbo adsorbens, carbo ligni (obat diare) tidaktambaha PGS (lendir)mengurangi dayakerjanya