RND Bagian 2 - Pengembangan Kemasan Produk

RESEARCH AND
DEVELOPMENT
BAGIAN 2
PENGEMBANGAN KEMASAN
INTRODUCTION
 Packaging is the process by which the pharmaceuticals are suitably packed so

that they should retain their therapeutic effectiveness from the time their
packaging until they are consumed. Packaging may be define as the art and
science which involves preparing the articles of transport.
FUNGSI DARI PACKAGING
Containment Protection
Information Compliance
CONTAINMENT
 Means the package prevent the product from touching or being exposed to the
environment. This requires the packaging:
 not to leak, nor allow diffusion and permeation of the product;
 to be strong enough to hold the contents when subjected to normal handling;
 not to be altered by the ingredients of the formulation in its final dosage form.
PROTECTION OF PRODUCT
 The packaging must protect the product against all adverse external influences that may affect its quality or
potency, such as:
 light, heat
 Moisture
 Oxygen
 biological contamination
 mechanical damage.
 The compatibility of the packaging with the active pharmaceutical ingredients is very important in
maintaining the integrity of the product.
 For primary packaging, it is necessary to know the possible interactions between the container and the
contents.
PRESENTATION AND INFORMATION
 Packaging is also an essential source of information on medicinal

products. Such information is provided by labels and package inserts
for patients.
COMPLIANCE
 Packaging and labelling may help to reinforce the instructions given by

the physician or the pharmacist, and improve compliance with drug
therapy. In this respect, packaging becomes a compliance aid.
PROTECTION OF PATIENT
 Packaging must protect the patient and indicate the integrity of the product.
 Packaging equipped with a tamper-evident device protects against incidental and
accidental poisoning.
 To protect children, several child-resistant closures have been developed
DETECTION OF COUNTERFEITING
 The design of the packaging must contribute to preventing the counterfeiting of

certain medicinal products.
 Tamper-evident containers can allow the visual inspection of the medicinal product
before use, and this may serve as a first stage in detecting counterfeit drugs.
CONTAINER AND CLOSURE
CONTAINER CLOSURE
 A pharmaceutical container is defined as a device  Closures is the devices by means of which

that holds or is intended to contain and protect a containers can be opened and closed.
drug and is or may be in direct contact with the
 Closures used for the purpose of covering drug
preparation.
containers after the filling process should be as
inert as possible
CONTAINER REQUIREMENT
 Must be neutral towards the material which stored in it.

 Must not interact with the substance which it holds.
 Help in maintaining the stability of the product
 Withstand wear and tear during normal handling.
 Dose can be drawn from it conveniently.
 Able to withstand changes in pressure and temperature.
 Must be non-toxic.
 Can be labelled easily.
 Pharmaceutically elegant appearance.
CLOSURE REQUIREMENT
 It avoids contamination of the product from dirt,

microorganism or insects.
 It prevents deterioration of the product from the effect of the
environment such as moisture, oxygen or carbon dioxide.
 Depending on the application, closures may have to be
pierced with a needle for intravenous sets. Such closures are
made from elastomeric materials (rubbers), while those that
cannot be pierced are generally made from plastics such as
polyethylene or polypropylene
 Depending on the type of container, closures may have
different shapes and sizes, e.g. stoppers for infusion or
injection bottles or plungers for prefilled syringes.
THE PACKAGING MATERIAL
Glass Plastic
Paper
Metal and
Board
GLASS
ADVANTAGES DISADVANTAGES
 Transparant  Heavy
 Available in various shapes and sizes.
 Easily Broken
 Can withstand the variation in temperature and
pressure during sterilization.  Harmful for Children
 Economical and easily available.
 Can protect the photosensitive medicaments from light
during their storage.
 Good protection
 etc
GLASS TYPE
•Neutral or •Treated
Borosilicate Sodalime for
Parenteral
Tipe
Tipe I
2
Tipe Tipe
3 4
•Regular •General
Sodalime fot Purpose
Parenteral Sodalime
PLASTIC
 They are light in weight and can be handled easily.  They are permeable to water vapour and
 They are poor conductor of heat. atmosphere gases.
 They have sufficient mechanical strength.  They cannot withstand heat without softening or
 They can be transported easily. distorting.
 They are unbreakable.  They may interact with certain chemical to cause
 They are available in various shapes and sizes. softening or distortion.
 They are resistant to inorganic chemicals.  They may absorb chemical substances, such as
preservatives for solution.
 They have good protection power.
PLASTIC CATEGORIES
METAL
 They are sturdy.  They are expensive.
 They are impermeable to light, moisture and  They may shed metal particles into the
gases. pharmaceutical product.
 They can be made into rigid unbreakable

containers by impact extrusion.
 They are light in weight as compared to glass
containers product.
HOW TO SELECT RIGHT MATERIAL?
 The choice of primary and/or secondary packaging materials will depend on the degree of :
 protection required,
 compatibility with the contents,
 the filling method and cost,
 the presentation for over-the-counter (OTC) drugs and
 the convenience of the packaging for the user (e.g. size, weight,
 method of opening/ re-closing (if appropriate), legibility of printing).
CASE STUDY
CASE 1
 Suatu produk sedang dalam pengembangan, dan akan memilih material kemasan yang akan digunakan.
 Bentuk cairan
 stabil terhadap oxygen
 Tidak stabil terhadap cahaya
 Apa usulan material kemasan yang digunakan?

CASE 2
 Suatu produk sedang dalam tahap pengembangan dengan karakteristik sbb:
 Produk stabil terhadap humidity
 Produk relatif murah
 Bentuk tablet
 Inginnya mudah dibawa kemana-mana
 Bentuk Kemasan apa yang paling sesuai?
 Sebutkan usulan materialnya.

CASE 3
 Suatu produk sedang dalam tahap pengembangan dengan karakteristik sbb:
 Produk sangat tidak stabil terhadap humidity
 Produk relatif cukup mahal
 Bentuk tablet
 Bentuk Kemasan apa yang paling sesuai?
 Sebutkan usulan materialnya.

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RESEARCH AND

 Packaging is the process by which the pharmaceuticals are suitably packed so

 Packaging is also an essential source of information on medicinal

 Packaging and labelling may help to reinforce the instructions given by

 The design of the packaging must contribute to preventing the counterfeiting of

 A pharmaceutical container is defined as a device  Closures is the devices by means of which

 Must be neutral towards the material which stored in it.

 It avoids contamination of the product from dirt,

 They are sturdy.  They are expensive.

 They can be made into rigid unbreakable

 stabil terhadap oxygen

 Tidak stabil terhadap cahaya

 Apa usulan material kemasan yang digunakan?

 Suatu produk sedang dalam tahap pengembangan dengan karakteristik sbb:

 Produk stabil terhadap humidity

 Produk relatif murah

 Inginnya mudah dibawa kemana-mana

 Bentuk Kemasan apa yang paling sesuai?

 Sebutkan usulan materialnya.

 Suatu produk sedang dalam tahap pengembangan dengan karakteristik sbb:

 Produk sangat tidak stabil terhadap humidity

 Produk relatif cukup mahal

 Bentuk Kemasan apa yang paling sesuai?

 Sebutkan usulan materialnya.

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