PHARMACEUTICAL PACKAGING | Attributes of Containers and Closures | CONTRACT PACKAGING | PACKAGING MATERIALS

PHARMACEUTICAL PACKAGING

Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use.Packaging may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister), which surround the pharmaceutical product from the time of production until its use.

WHO defines packaging as a process that a bulk material must, undergo to become a finished product.

Packaging of a pharmaceutical product is aimed at ensuring that medicines arrive safely in the hands of the patients for whom they are prescribed. Pharmaceutical packaging adds value to the product by preserving quality and prolonging the shelf-life. It also plays a major role in creating brand awareness and expanding consumer preferences. Products are packaged to meet the criteria of safety, convenience, and attractiveness.

The global pharmaceutical packaging market was valued at $42 billion in 2008. The market is expected to reach a value of $68 billion by 2015.

CONTRACT PACKAGING.

Modern industry is an unstable mixture of markets, materials, and techniques that requires a certain amount of flexibility to be successful. One of the sources of the necessary operating know-how and production! facilities are the contract packager. Nearly all companies, from the smallest! to largest, avail themselves of such a satellite manufacturing plant.

The contract packager provides equipment and labor at a competitive price and is a means of starting many new products with a minimum” amount of risk.

when a product has become established or has at least shown some growth potential, the manufacturer will want to consider taking it away from the contract packager and bringing it into his own plant. This would. provide for better controls and opportunities for cost improvements through mechanization and purchasing power.

Definitions

 Ampoule

A container sealed by fusion and to be opened only by breaking. The contents are intended for single use only.

Blister: 

A multi-dose container consisting of two layers, of which one is shaped to Contain the individual doses. Strips are excluded.

Bottle:

A container with a more or less pronounced neck and usually a flat bottom.

Containers: 

A container for pharmaceutical use is an article, which holds or is intended to contain and protect a drug and is or may be in direct contact with it. The closure is a part of the container. The container and its closure must not interact physically or chemically with the substance within in any way that would alter its quality.

 

Gas Transmission:

Volume in milliliters, per 100 in? per 24 h at 1 am pressure and 75°F, passing through a 0.001-inch thick film.

Hermetically closed containers 

must protect the contents from extraneous matter and loss of the substance, and be impervious to air or any other gas under normal conditions of handling, shipment, or storage.

Light resistant container: 

A light-resistant container protects the contents from the effects of light under the specific properties of the material of which it is composed, including any coating applied to it, A light-resistant container essentially shields the contents from the effects of light.

A clear and colorless or translucent container may be made light. resistant using an opaque covering, in which case the label of the Container bears a statement that opaque covering is needed until the Contents are to be used or administered.

Multiple-dose container; 

A multiple-dose container is a multiple Unit container for articles intended for parenteral administration only,

Single-dose container: 

A container for single doses of the solid, semi. Solid or liquid preparations. Thus single-dose and multiple-dose containers are meant for Parenteral) administration only while unit dose containers is meant for other than parenteral administration.

Single Unit container:

A single unit container can hold g quantity of the drug product intended for administration as a single dose or a single finished device intended for use promptly after the container; is opened. The immediate container and/or outer container or protective packaging is so designed as to show evidence of any tampering with the contents.

 

Strip: A multi-dose container consisting of two layers, usually provided with perforations, suitable for containing single doses of solid or semi-solid preparations. Blisters are excluded.

Tamper-evident container: A tamper-evident container is fitted with a device or mechanism that reveals irreversibly whether the container has been opened. :

Tamper-resistant container: The container or individual carton of a sterile article intended for ophthalmic or otic use, except where extemporaneously compounded for immediate dispensing or prescription, shall be so sealed that the contents cannot be used without obvious destruction of the seal.

Tightly-closed container: A tight container protects the contents from contamination by extraneous liquids, solids, or vapors from loss of the article, and from efflorescence, deliquescence, or evaporation under the normal conditions of handling, shipment, storage, and distribution, and is capable of tight re-closure.

Unit Dose container: A unit dose container is a single unit container for articles for administration by other than parenteral route as a single dose, direct from the container.

Well-closed container: A well-closed container protects the contents from extraneous solids and loss of the substance under normal conditions of handling, shipment, or storage.

Package Design

The basis of packaging design and performance is the component materials. Along with important features like child resistance, tamper evidence, protection against counterfeiting, and increased patient convenience, packaging has become a marketing tool for the product ‘Hence new packaging designs would help protect the brand identity of _the product and become an essential part of drug manufacturing.

Contents of Packaged Dosage Forms: IP 2014 has prescribed tests and specifications for oral dosage forms and preparations intended for topical use packaged in containers with labeled quantity up to 100 g or 300 ml or 1000 units, as the case may be.

Ointments, Creams, Pastes, Granules, and Powders for Oral Liquids, Liquids, and Suspensions: The weights of 10 filled containers are taken (W1), the contents of each container are removed and weighed again (W2). The average net weight of contents of the 10 containers is not less than the labeled amount and the net weight of the contents of any single container is not less than 91% and not more than 109% of the labeled amount where the labeled amount is 50g or less, or not less than 95.5% and not more than 104.5% of the labeled amount where the labeled amount is more than 50g but not more than 100g or less.

Capsules, Pessaries, Suppositories, and Tablets: The average number of the contents in the 10 containers is not less than the labeled amount and the number in any single container is not less than 98% and not more than 102% of the labeled amount.

PACKAGING MATERIALS 

Packaging material is defined as any material, including printed material, employed in the packaging of a pharmaceutical product, excluding any outer packaging used for transportation or shipment. Primary packaging materials are those that are in direct contact with the product.

Commonly used packaging materials are categorized as primary packaging material, secondary packaging material, and accessories as shown in table 25.1.

Packaging components forming part of the pack that contains the product and are in direct contact with the product for example bottle, cap, liner, etc., are called the primary pack. The main functions of the Primary pack are to contain or restrict the product and to provide

protection to the product. Primary packaging materials should have the following properties: (i) It should have no adverse effect on the product due to chemical reaction, leaching, absorption or adsorption, particulate contamination.

(ii) It should not be adversely affected by the product.

(iii) It should not be influenced by adverse manufacturing conditions (e.g. sterilization, freezing).

Secondary packaging materials consist of all other packaging mates. trials used external to the primary pack, which provide physical protection to ensure safe warehousing and mechanical protection required in a shipment and transport, e.g. cartons, corrugated boxes, shipment containers, etc,

Functions of secondary packaging include (i) Protection from the excessive transmission of reactive gases, moisture, light, microbes. (ii) Protection of flexible containers. (iii) Protection from rough handling during transportation.Dosing dropper, calibrated spoon, etc. are considered as associated components in packaging.

Unit-Dose Packaging

Apart from primary and secondary packaging, two types of special packaging are currently in use. These include (a) unit-dose packaging. and (b) device packaging. Both are becoming more and more popular as they are user-friendly, guarantee safer medication, more convenient. improve patient compliance, and are more useful for less stable products.

Unit dose packaging means a single unit container for administration? as a single dose, direct from the container. Essentially a single item or @ specific quantity (dose) is enclosed within a disposable pack.

Device packaging; Packaging with the aid of an administration” device is user-friendly and also improves compliance. Such device

ensure that the medicinal product is administered correctly and in the right amount. Device packaging permits easier administration using devices such as prefilled syringes, droppers, transdermal delivery systems, pumps, and aerosol sprays.

A list of packaging materials used in pharmaceutical packaging 1s is given below. |,

Functions of pharmaceutical packaging

The fundamental functions of pharmaceutical packaging can be summarized as (P/ICPIC) protection (against light, reactive gases, moisture, microbes, physical damage, pilferage, and adulteration), identification, compatibility, presentation, information, and convenience.

A package should maintain the integrity and stability of the Product and should be economical and disposable.

The choice of packaging material will depend upon (i) dosage form desired, (ii) degree of protection required, (iii) compatibility with the dosage form, Civ) ‘presentation and aesthetics, (v) customer convenience e.g. size, the weight of dosage form, Ga filling method, (vii) sterilization method to be employed, and (viii) cost. In addition to packaging material, the selection of a pack is important. The main objective of selecting the package for medication is to deliver a drug to a specific site of effective activity in the patient and the

packaging must perform this function. The product/pack couple is designed as a composite unit to achieve the above objective.

The choice of packaging for a specific pharmaceutical product depends upon:; – @) nature of the product and its compatibility ‘with the material, (ii) type of patient—whether child, elderly, adult, (iii) type of dose—granules, tablet, ointment, (iv) method and site of administration—dispensing device, etc., @y) method of distribution—through the hospital, pharmacy, retailer,

  1. i) capacity of the packaging needed——-small bulk for pharmacies, OPD; and required shelf-life and likely sales area.

 

Containers and closures are employed primarily to carry a preparation, to protect it, and at times to identify it. They afford consumer convenience and a device to the seller for transportation of dosage forms.

A pharmaceutical container is a device that holds the drug and may be in direct contact with the product. If the container is in direct contact with the drug(s) it is called an immediate container.

A closure seals the container to exclude air, dust, moisture, microorganisms, etc. and prevents the loss of liquids and other volatile substances from the product.

The characteristics of containers and closures may have a profound influence on the stability of many pharmaceuticals.

Attributes of Containers and Closures

(1) They should be able to hold the product without loss on account of leakage, spillage, or permeation.

(2) They should afford protection against environmental conditions during anticipated storage periods. Light, air, and moisture are the most important factors. Light can bring about photolytic decomposition due to exposure to certain wavelengths of light. Air, if present inside the container, may catalyse oxidative degradation or other chemical changes. Similarly, moisture may also affect the stability of moisture-sensitive preparations. Sterile products are required to maintain sterility implying the exclusion of microorganisms into the containers. The containers should also afford protection from molds and insects attack.

(3) They must suit the function of the product both in form and size. Thus multi-dose injectables cannot be packed in ampoules.

(4) The containers should not interact with the material they are containing. The most common problem is due to the alkalinity of the glass, which is generally employed for container fabrication. If alkalinity is imparted to the preparation, the system may get destabilized as a result of a change in pH thus rendering the preparation either less efficacious, useless, or even harmful. Further, physical changes e.g. precipitation may raise suspicion about the quality of the product.

Some of the closures might absorb either the active ingredient or the preservative from the preparation thus rendering it either worthless or prone to decomposition. At times, the components present in the preparation may also leach out some component from the material employed for the construction of the closure e.g. zinc oxide and sulphur. This may affect the preparation adversely. The sorption of water by rubber closures used for multi-dose injections and haze formation from rubber closures are well known problems, Haze formation is due mainly to zinc salts or sulphur. Thus the materials that are selected for the construction of containers and closures have to be given careful consideration.

 

(5) The containers should facilitate distribution and contribute to the more efficient, safe, and convenient use of contents. Containers for eye drops and ophthalmic ointments must provide ease of application without exposing the product to microbial contamination.

(6) The containers should possess enough strength to withstand the RIgours of normal handling and as such, they should be robust. Although the use of plastic containers is an answer to this problem yet the glass containers are commonly employed on account of their elegance.

 

(7) Containers used for specific preparations e.g. injectables, which are to be sterilized after filling, must withstand the changes in temperature, and pressure. Similarly, the containers for pressurized packagey (aerosols) should also be able to maintain the desired pressure characteristics within the period of storage and use.

(8) The cost of the container and closure is an integral part of thy total cost of the dosage form. Hence it has to be kept as low as Possible, Without compromising the quality of the product.

(9) Apart from their essential function—protection; containers ang closures should be such as to facilitate identification of the product ¢.2 whether for internal or external use.

Materials for Construction of Containers

Most of the containers and closures are fabricated from glass, metals, tubber, plastics, or a combination of these materials.

 

Glass : Traditionally glass containers have been most widely used for pharmaceutical products and until the last six decades it was perhaps the only material commercially available for the manufacture of quality containers for drugs and their preparations. Glass ensures inertness, visibility, strength, rigidity, moisture protection, ease in the filling, durability, convenience in cleaning and economy. Moulded bottles are commonly used in the pharmaceutical industry.

 

Commercially available types of glass are (i) soda-lime glass; (it) borosilicate glass; (iii) neutral glass; (iv) sulphured glass; and: (v) silicone treated glass.

 

Soda-lime glass is the most common type and consists of calcium and sodium oxides and silica. They impart alkaline reaction to the product and hence for alkali-sensitive products, the glass containers should have passed the tests for Limits of Alkalinity as prescribed various pharmacopoeias. Borosilicate glass contains boron oxide of aluminium oxide, Neutral glass having properties of both is considered most suitable for medicinal products. It is however subject to flaking. Sulphured glass is prepared by exposing the svda-lime glass to moist sulphur dioxide above 500°C so that the surface alkali is converted into sulphate (sulphured), which is then washed off to expose a tough silic® rich surface leaving very little alkali to contaminate the contents. Sul phured glass containers are commonly used for parenteral até alkali-sensitive products.

 

Silicone treated glass is coated with silicone on the inner surface of the container. Although it is not very popular in pharmaceutical indust’y’

It is comparatively less alkaline and is suitable for alkali-sensitive products.

‘Following four types of glass are accepted for packaging in the pharmacopoeias:

Type I — Highly resistant borosilicate glass

Type II —Treated soda-lime glass

Type III — Soda-lime glass

Type IV — General purpose soda-lime glass.

The greatest advantage of glass is transparency, which allows a visual inspection of the contents. Colored glass containers are used to protect the drugs against photolytic decomposition, amber-coloured glass is most commonly used. Amber colour may vary from light yellowish to deep reddish-brown and is obtained by the addition of carbon and sulphur or iron and manganese dioxide. This glass shows a high degree of chemical inertness. It is impervious to gases, solutions, and solvents. It can be processed at extremely high speeds. Heat resistance makes glass particularly suitable for thermal sterilization. The clarity of glass is an attribute

that helps in promoting sales. Lastly, glass can be easily cleaned without surface damage e.g. scratching or bruising.

 

 

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