Pharmaceutical Packaging Technology

Prepared by: Jalal Uddin Lecturer World School of Pharmacy World University of Bangladesh

March 17 1 Definition

The packaging can be defined as the economical means of providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its .

Pharmaceutical packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages.

March 17 2 Ideal packaging requirements

1. They must protect the preparation from environmental conditions. 2. They must not be reactive with the product. 3. They must not impart to the product tastes or odors. 4. They must be nontoxic. 5. They must be FDA approved. 6. They must meet applicable tamper-resistance requirements. 7. They must not be the cause of product degradation. 8. They must be adaptable to commonly employed high

speed packaging equipment. March 17 3 Functions of packaging 1. Product Identification: Packaging greatly helps in identification of products. 2. Product Protection: Packaging protects the contents of a product from spoilage, breakage, leakage, etc. 3. Facilitating the use of product: Packaging should be convenience to open, handle and use for the consumers. 4. Product Promotion: Packaging is also used for promotional and attracting the attention of the people while purchasing. 5. Marketing: The packaging and can be used by marketers to encourage potential buyers to purchase the product.

March 17 4 6. Convenience: Packages can have features that add convenience in distribution, handling, stacking, display, sale, opening, re-closing, use, dispensing, reuse, , and ease of disposal. 7. Barrier protection: A barrier from oxygen, water vapor, dust, etc., is often required. Permeation is a critical factor in design. Some packages contain desiccants or oxygen absorbency to help extend shelf life. Keeping the contents clean, fresh, sterile and safe for the intended shelf life is a primary function. 8. Security: Packaging can play an important role in reducing the security risks of shipment. Packages can be made with improved tamper resistance to deter tampering and also can have tamper-evident features to help indicate tampering. Packages can be engineered to help reduce the risks of package pilferage.

March 17 5 Selection of the Packaging Materials 1. On the facilities available, for example, pressurized dispenser requires special filling equipment. 2. On the ultimate use of product. The product may be used by skilled person in hospital or may need to be suitable for use in the home by a patient. 3. On the physical form of the product. For example, solid, semi-solid, liquids or gaseous dosage form. 4. On the route of administration. For example, oral, parenteral, external, etc. 5. On the stability of the material. For example, moisture, oxygen, carbon dioxide, light, trace metals, temperature or pressure or fluctuation of these may have a deleterious effect on the product.

March 17 6 6. On the contents. The product may react with the package such as the release of alkali from the or the corrosion of the metals and in turn the product is affected. 7. On the cost of the product. Expensive products usually justify expensive packaging

March 17 7 Hazards encountered by package

Hazards encountered by the package can be divided into three main groups. a) Mechanical hazards b) Climatic or environmental hazards c) Biological hazards.

The only exception is theft, which can be a serious risk with drugs and may demand special protection in certain cases.

March 17 8 a) Mechanical hazards: 1. Shocking or impact damage 2. Compression 3. Vibration 4. Electrical conductance 5. Abrasion b) Climatic or environmental hazards: 1. Moisture 2. Temperature 3. Pressure 4. Atmospheric gases 5. Light 6. Solid airborne contaminants.

March 17 9 c) Biological hazards. 1. Microbiological hazards 2. Chemical hazards

March 17 10 Types of packaging Primary packaging is the material that first envelops the product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents. Examples: , , ,Dosing dropper ,Closures (plastic, metal) ,Syringe ,Strip package, Blister packaging.

March 17 11 Secondary packaging is defined as the packaging that lies outside the primary packaging. It is perhaps used to group primary packages together. Example: and boards, ,Corrugated fibers , manufacture)

March 17 12 Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized that packs tightly into containers.

March 17 13 Apart from primary and secondary packaging, two types of special packaging are currently in use, as follows: Unit-dose packaging: This packaging guarantees safer medication by reducing medication errors; it is also more practical for the patient. It may be very useful in improving compliance with treatment and may also be useful for less stable products.

Device packaging: Packaging with the aid of an administration device is user-friendly and also improves compliance. This type of packaging permits easier administration by means of devices such as pre-filled syringes, droppers, transdermal delivery systems, pumps and aerosol sprays. Such devices ensure that the medicinal product is administered correctly and in the right amount

March 17 14