CARA COMPOUNDING

OBAT YANG BAIK

ANITA SUKMAWATI
Bagian Farmasetika, Fakultas Farmasi
Universitas Muhammadiyah Surakarta
PENGERTIAN COMPUNDING:
• Kegiatan menyiapkan, pencampuran, peracikan,
perubahan, pengemasan dan pelabelan obat, sediaan obat
atau alat kesehatan berdasarkan resep dokter, medication
order atau inisiatif antara dokter-pharmacist-pasien dalam
hal praktek profesional (USP chapter 975).
• Extemporaneous compounding: penyiapan obat
berdasarkan resep dokter.
• Extemporaneous compounding dilakukan ketika
kebutuhan obat untuk pasien tertentu tidak dapat
dipenuhi oleh produk obat yang ada dipasaran.
YANG TERMASUK KEGIATAN COMPOUNDING:
• Penyiapan obat untuk pasien manusia atau hewan
• Penyiapan obat-obatan atau sediaan berdasarkan obat-
obatan rutin yang diresepkan.
• Rekonstitusi atau manipulasi produk komersial yang
memerlukan 1 atau lebih bahan tambahan.
• Penyiapan obat atau sediaan obat untuk tujuan tertentu
misal penelitian, pengajaran, analisis kimia.
• Penyiapan obat atau sediaan obat oleh dokter yang
diperbolehkan oleh aturan setempat.
 COMPOUNDING VERSUS MANUFACTURING
COMPOUNDING
• Preparasi kompenen
pharmaceutical dalam bentuk
sediaan yang diatur oleh
peraturan dan standar untuk
menjamin kualitas dan
keamananan.
• Prepared with consulation
between pharmacist-patient-
prescriber.
• Menyediakan sediaan yang
dapat diatur secara terapetik
untuk meningkatkan kualitas
hidup pasien.
MANUFACTURING
• Subject to FDA regulation
and GMP.
• Require drug
identification number.
• Products that are
independently produced
by a manufacturer
without a consultation
between pharmacist,
patient and prescriber.
ALASAN DILAKUKANNYA COMPOUNDING
• Dosages and strength not available in commercial
products.
• Dilution of adults doses is needed for paediatric or
geriatric strength.
• Conversions of solid dosage forms to solutions or
suspension s is needed.
• Combination of products are not available in manufacturer
products.
• Inactive ingredients of commercial product could induce
allergic in individuals.
APA SAJA TANGGUNG JAWAB SEORANG
COMPOUNDER?
• Have accurate knowledge and expertise to prepare the
dosage form.
• Confirm the need for a compounded product.
• Maintain access to contemporary equipment.
• Use the quality ingredients and procedures.
• Labelled properly.
• Select the suitable containers for each unique products.
• Safe and acceptable storage
• Provide documentation to ensure accurate checking,
duplicating and tracing.
ASPEK-ASPEK COMPOUNDING OBAT YANG BAIK:
• Personnel
• Facilities and equipment
• Ingredient standards.
• Quality assurance and quality control
• Packaging, storage and labelling
• Documentation and record keeping.
PERSONEL
• Pharmacist or person that compound the drugs should
have knowledge and skill to be responsible for the
preparation of the product.
• Pharmacist should be aware of good compounding
principles and practices.
• If pharmacist unable to compound a drug product ,
pharmacist should refer the patient to pharmacist with
ability to prepare product.
• Pharmacist should have sufficient information related to
knowledge decision regarding the formulation process of
the compounding.
TUGAS FARMASIS DALAM COMPOUNDING
FARMASI:
• Assist individuals requiring a compounded item.
• Counsel individuals on the appropriate use of the compounded
product.
• Determine whether the product should be compounds in steril
manner.
• Ensure the quality and accuracy of the ingredients.
• Calculate required quantities.
• Be knowledgeable of the purpose of each ingredients.
• Recognize the potential incompatibilities.
• Determine the equipment needed to compound the product.
• Prepare the product in logical, safe and pharmaceutically elegant
manner.
• Document the required information to maintain accurate record.
FACILITIES AND EQUIPMENT
PREMISES
• Should be clean, sanitary
and orderly
• Should be easy to clean all
surfaces
• Should prevent
contamination of
medication
EQUIPMENT
• Be situated in area that permits
its function.
• Be easy to clean  minimize
contamination.
• Suitable for preparing desired
compound.
• Kept clean, dry and protected
from contamination.
• Equipment should be calibrated
on scheduled basis.
INGREDIENT STANDARDS:
• Must involve high quality chemical
INGREDIENT STANDARDS:
• Active ingredients can be obtained from manufactured
drug products.
• Use the high-quality supplier and the same supplier to
ensure the consistency of quality.
• Secondary supplier could be use to prevent unexpected
shortfalls suply.
• Certificate of analysis (CoA) should be obtained for record.
INGREDIENT STANDARDS:
• Selection of ingredients are based on:
• Solubility
• Stability
• Compatibility
• Patients conditions: allergy, diseases state, ability to
administer, other medications
• Intended use
• Potential drug-drug interaction
• Medication administration frequemcy
• Route of administration.
QUALITY CONTROL AND QUALITY ASSURANCE:
• Pharmacist should ensure the accuracy and completeness
of the compounded preparation by reviewing each step in
the preparatory, compounding, final check and sign-off
phases.
• Aspects to be reviewed:
•Appropriate ingredients, adjuvant and equipment.
•Calculations
•The accuracy of measurement.
•The formulation is appropriate for the intended use
and stability limits of the preparation.
 QUALITY CONTROL QUALITY ASSURANCE
• Day-to-day monitoring for • Evaluation of product
compounding product. quality by individual
• Daily assessment of all product  chosen
operations, from raw randomly example of final
materials, product product.
preparation, testing, and • Including Standard
documentation. operating procedures
(SOP), documentation,
verification and testing.
PACKAGING:
• Selection of packaging depend on physical and chemical
properties of compounded preparation.
• Packaging materials should not interact with the
preparation.
• The characteristic of container should be:
• Inert, visibel, strength, rigid, moisture protection, ease
to closure and economic.
• Plastic can be used for container  should meet USP 34/
NF 29 standards.
STORAGE:
• Chemical should be stored according the manufacturer’s
direction or meet the requirement in USP 34/NF 29.
• Generally, compounding chemicals should be stored in
tightly closed, light resistant container at room
temperature.
• Some chemicals should be stored in refrigerator.
• Chemicals should be stored off the floor, preferably using
shelves, with dry environment.
• Chemical stored in compounding area should be detached
from cartons or boxes.
LABELLING:
• Labelling should include:
• Generic or chemical names of active ingredients
• Strength or quantity
• Lot number
• Estimated of Beyond-use-date
• Special storage requirements (if any)
• Name and address of compounder.
LABELLING:
• If there is excess preparation, the label should be written
on the excess of preparation, including:
• Complete list of ingredient
• Preparation date
• Assigned beyond-use-date
• Appropriate testing
• Control number
DOCUMENTATION AND RECORDS
• Record should maintained for compounding, at least:
• Formulation records
• Compounding records.
• SOP, including SOP for equipment maintenance.
• Ingredients record: CoA, MSDS
• Record related to complaints from patients and adverse
event should be maintained at least 2 years from the date
of dispensing.
• Suspected adverse reaction should be reported to health
authorities.
COMPOUNDING PROCESS

FINAL
PREPARATION COMPOUNDING SIGN-OFF CLEAN-UP
CHECK
GENERAL CONSIDERATION FOR DOSAGE FORM
DESIGN IN COMPOUNDING:
CHEMICAL PROPERTIES PHYSICAL PROPERTIES
• Purity • Particle size
• Polymorphisme • Melting point
• pH • Solubility
• pKa

BIOLOGICAL PROPERTIES
• Membrane permeability
 partition coefficient.