Information on containers will be found in the B.P.C, B.N.F. and B.P. The pharmaceutical society of Great Britain has published its “Recommended on Containers for Dispensing (1972)”. British Standards 1679:1965, 1967, 1968 and 1969 gives specifications of most type of containers used in dispensing.
Desirable Features of an Ideal Container:
1: The container must be rigid enough to prevent damage to the contents, e.g. fracture of the tablets and crushing of capsules.
2: The material of construction must not react with contents.
3: The closure must prevent
(a): Access of moisture e.g. to moisture sensitive tablets and, because their shells are hygroscopic, to capsules
(b): loss of moisture from creams and from water containing ointments and pastes
(c): unintentional escape of content
(d): Entry of dirt or other contaminations such as odorous vapors that might cause tainting
4: The closures must e easily be replaced and removed
5: It must not be difficult to abstract the contents or to empty the container completely
6: For many products, protection from light must be given
7: Medicament or adjuncts must not be adsorbed by the container materials nor must diffusion through the walls be possible
8: It must be easy to label the container correctly
9: It must have a pharmaceutically elegant appearance.
1. Oral Liquid Preparations Intended to be Swallowed:
Examples: Draughts, elixirs, emulsions, certain type of gargles, oral gels, linctuses, mixtures, pediatric drops, oral antibiotic suspensions and syrups.
The container of choice for most of these products is the Metric Medicine Bottle made to British standard specifications 1969: part 6:1967.
This has following features:
(a): For cheapness: It is made from lime soda glass
(b): It is ovoid in section but the back is flatter than the front. This allows the bottle to rest steadily.
(c): It is free from the molded graduation that used to be found on some imperial bottles and which are not accurate enough for the measurement of the dose volume
(d): It has a special lip that facilitates pouring.
(e): It can be fitted with two types of closures
· White polypropylene
· Black, thermosetting plastic
(f): It is colorless but when the protection from light is necessary light resistant, emulsion type or plastics bottles are used or patient can be instructed by the label to store away from light.
(g): It is available in six sizes (50, 100, 150, 200, 300 and 500ml)
For preparations of high viscosity, such as emulsions and oral gels a wider mouthed bottle is preferred and is available in clear and amber glass and for volumes of 50, 100, 200 and 500ml.
It is recommended that the following preparations should not be stored or dispensed in Certor Polyvinyl Chloride bottles.
(a): Chloroform and morphine tincture B.P.C., alone and in aqueous mixtures containing more than 5 per cent.
(b): Mixtures or dispersions containing chloroform in excess of its aqueous solubility (0.5 per cent v/v); e.g. double strength mixtures, concentrations containing high proportion of chloroform spirit, chloroform emulsion, or chloroform and morphine.
(c): Aqueous mixtures containing chloroform in solution with high concentrations of electrolyte, because the chloroform may be salted-out.
(d): Chloroform water B.P. and mixtures containing it, if the storage and/or period of use are likely exceeded 6 weeks.
(e): Anise, clove or peppermint oil.
2. Oral Liquid Preparations Not Intended to be Swallowed:
Examples are mouthwashes, throat paints and most of the gargles. Although these preparations are used in the mouth or throat they should not be swallowed in large amounts.
Container bottles are the fluted or ribbed ovals. Ribbed ovals are closed with the plastic screw caps requiring impervious liners. Colorless bottles are used unless protection from light is necessary.
A wide mouthed ribbed jar is more satisfactory for throat paints since these are applied with long, rather large, straight or curved brushes that cannot be introduced easily into a narrow mouthed container.
3. Liquid Preparations for Application to the Skin or Use in the Body Cavities
Examples are Applications, collodions, liniments, lotions, paints and some solutions are applied to the skin while douches, ear drops, sprays and other solutions are used in the body cavities. Extemporaneously- dispensed fluid preparations in this group are normally packed in colored fluted bottles but other containers (e.g. plastic capsules for ear drops, squeeze bottles for lotions and single-use plastic packs with rectal nozzle, for enemas) are often used by the manufactures, and are permitted provided they are clearly distinguishable from type used for internal product. The combination of fluting and color is intended to warn against the oral use. Color is only difference between the two bottles and the ribbed ovals used for mouth washes. However for some classes or product special factors are taken into account.
Semisolid Preparations for Application to the Skin or Mucosae
Examples are Ointment, creams, pastes, jellies, and poultices etc
1. Collapsible Metal and Plastic Tubes:
a. Its narrow orifice prevents serious contamination of unused parts of contents.
b. Wastage is reduced, since the patient is less likely to remove an excessive amount.
c. When part of the preparation is expelled it is not replaced, as in other containers, by equivalent volume of air; consequently, microbial contamination and oxidative or hydrolytic degradation of the remaining contents are reduced. However the advantage is not obtain with certain plastic tubes, e.g. those of low density polythene, because being somewhat elastic they tend to return to their original shape after compression thus sucking the air.
d. Nozzle type applicators can be fitted to facilitate administration into body cavities such as nose or vagina. These often have the tiny orifices that further decrease the chance of contamination.
Most collapsible tubes are made of aluminum, although tin, lead, tin coated lead and plastics are also used. Aluminum tubes have good resistance to corrosion because the surface of film of oxide. However if this film is removed by the contact with solutions of mercury compounds a liquid amalgam is produced to which the oxide cannot adhere and consequently, rapid oxidation, occurs, with production of moss like excrescences of oxide. Unless adequately protected by an internal lacquer, aluminum tubes are unstable for creams containing organic mercury compounds as preservatives; examples are Cetomacrogol Cream formula B, B.P.C. and Fluocinolone Cream B.P.C. both of which are preserved with thiomersol.
Aluminum is attacked by acids, alkalis and ethyl alcohol. It contains a trace of iron and if used for products containing electrolyte, particularly chlorides, galvanic corrosion may take place. The hydrogen evolved cab cause decomposition of medicaments, bleaching of coloring matters and blowing of the tube, while the corrosion itself may penetrate the metal causing leakage.
Corrosion may be prevented by:
1: Coating the tube internally: If aluminum tubes are used for buffered creams B.P.C, they must be internally lacquered.
2: Including the buffer in preparation: A suitable mixture is 0.1 per cent of anhydrous disodium hydrogen phosphate and 0.02 percent of sodium dihydrogen phosphate dehydrate. Use of buffer is allowed in hydrocortisone and neomycin creams of B.P.C.
2. Glass Plastic Pots:
Suitable alternatives are wide mouthed squat, cylindrical pots made from glass or suitable plastics having a plastic (or occasionally metal) screw (or, sometimes in case of plastics, slip over cap). Glass pots may either be colorless and either clear or amber color or opal white. Glass is inert, hygienic and provides stability considerations allow transparency, the content can be seen. Unless returned by patient for reuse, they are more expensive than plastics.
Solid Unit-Dose Preparations
A. Intended to be Swallowed or Sucked
Examples are Cachets, hard and soft capsules, pills, tablets and lozenges.
1. Paper Board Boxes:
Until comparatively recent, solid unit dosage forms were often packed in paper board containers made according to British Standard Specification 1679:Part 1:1969. These are available in many types and sizes.
(a): Drums with metal or paperboard bases and press in or slip-over lids.
(b): Rigid boxes with lift-off is hinged lids, or with a sliding drawer
(c): Collapsible cartons with tuck-in end (skillets).
Cheapness and the small storage space needed for the collapsible form made these particularly popular. However because they release their contents rather easily and a careless patient may damage the flaps, they are the least satisfactory of all types.
Nevertheless since reasonably cheap and much more reliable alternative container are available, the pharmaceutical society of Great Britain has long recommended, and the drug tariff now directs that solid oral dosage forms shall be dispensed in containers of glass rigid plastic or extruded aluminum. The only exceptions are foil or blister packed tablets. These are if necessary already well protected from air and light therefore can be dispensed in strong paperboard boxes or folding cartons that are robust enough to prevent physical damage
Oval or rectangular bottles or tubular vials, closed with plastic or metal screw that contain a suitable insert or, for metal caps, are internally lacquered. The pharmaceutical society recommends amber glass jars or vials for all tablets and capsules to prevent accidental packaging of light sensitive products in a container allowing free light transmission.
Containers made from polystyrene, high density polythene and poly propylene and concluded that most gave protection from moisture for short period to all but highly moisture sensitive tablets. Vials of polyvinyl chloride are also available. This polymer provides a much better barrier to water vapor than polystyrene and less expensive than polypropylene.
British standards 1679: part 4: also covers tablet containers and specifies a test for water vapor permeable (which, at the same time, is a test or closure effectiveness) and test for mechanical, strength, and light protection. The pharmaceutical society recommends that when plastic containers are used for tablets and capsules they should be amber or opaque.
The aluminum containers used in pharmacy are made by impact extrusion, a process that avoids a seam in the side of tin. They can be reliably sealed because they accept a verity of closers, e.g. an aluminum screw cap with a resilient wad, or slip-on, or push in, plastic caps.
(a): They are robust and unbreakable; this is especially advantageous in packaging of large numbers of tablets.
(b): They are light in weight and this reduces transport costs.
(c): They require less storage space than alternative containers.
(d): Mechanical filling is simple.
(e): The label can be printed directly on the container.
(f): They provide protection from light.
(g): They are also liked by patients because they cannot be broken when carried in the pockets or handbags and there is little risk of content escaping or being damage by crushing.
Minor disadvantages include:
(a): Sometimes the screw caps are difficult to engage and gritty in action. In addition the edges of tin can are really sharp.
(b): Unless lacquered internally, which adds to cost, they leave gray marks on certain tablets (particularly sugar coated tablets) due to abrasive rubbing against the wall. They should be lined with paper before use.
B. Intended to Use in Body Cavities:
Examples are Pessaries and Suppositories.
1. Compressed Pessaries and Suppositories are dispensed in the type of container used for tablets with appropriate labeling to indicate that contents should not be taken in the mouth.
2. Molded Pessaries and Suppositories are dispensed in the shallow partitioned, rigid, paperboard boxes, lined with waxed or suitably treated paper, or in plastic or metal containers. Sometimes the manufactures make suppositories by pouring the molten base into a strip of disposable plastic moulds in which the products are then marketed. This technique has advantage that the finished products are not touched by hand. Unplasticised polyvinyl chloride and low density polythene have been used for moulds.
3. Molded Pessaries and Suppositories containing volatile or hygroscopic ingredients, or intended for use in tropical or subtropical countries, should be wrapped singly in waxed or suitably treated paper, or metal foil, or enclosed in a form of strip packing.
1. For Oral Administration:
a. Bulk powders and granules are usually packed in wide mouthed, screw-capped, plain, and colorless glass jars, but suitable plastic and paper lining aluminum containers are also acceptable.
b. Individual powders are dispensed in paperboard or plastic boxes or folded paperboard cartons. These must give adequate physical protection and the choice is usually box with sliding drawer. Powders containing oily or volatile ingredients are doubly or triply wrapped, using an inner wrapper of waxed paper and/or an outer wrapper of metal foil; they should be packed in an airtight container, such as a screw-capped jar, with an impervious liner, or plastic box.
2. For Use Externally or in Body Cavities:
Examples include Dusting powders which are applied externally; sterile dusting powders and insufflations which are used in body cavities.
a. Ideally, dusting powder should be supplied in air tight, glass or plastic jars with an enclosable perforated lid. When such a closure is not available, an ordinary screw cap, with an impervious liner is used, and the patient is instructed to apply the powder with swab of clean wool or gauze.
b. In emergency, and provided not more than about a week’s supply is issued, cylindrical paperboard drums, coated or treated to limit access of moisture, which would destroy the essential free-flowing property or powder, may be used. These drums have sprinkler holes at top which, initially, are covered with a card disc; the patient should advise to replace this after effective as a seal, due to increasing damage.
c. Extemporaneously dispensed insufflations are packed in wide mouthed colorless screw-capped glass jars, but plastic squeeze bottles are often used by manufacturers.
Child Resistant Containers:
These have been produced in response to demand for greater protection of children against accidental poisoning. They take advantage of the greater strength of adults and generally incorporate locking mechanism. e.g. the Palm and Turn Tablet Container
Among problem that complicate their design are-
(a): Wear and Tear
(b): Susceptibility of opening by mouth