Suppository strip

A suppository filling machine enables a serial filling of large quantities of suppositories. The apparatus and its use are described in Sect. 28.7.2. A manually operated machine keeps the mass automatically homogeneous. The tap is operated manually as is the movement of the plastic suppository strips. An automatic machine fills the plastic molds automatically and often transits them too. The filling process of a suppository filling machine always has to be validated. The content of both the first and the last suppositories may not meet requirements. 

Suppositories can be poured directly into the suppository strips or into metal molds after which they are packaged separately. Pessaries (vaginal suppositories) are also packaged in suppository strips. 

Many users find it difficult to open suppository strips. Especially for patients with a limited hand function suppository strips are a very difficult container to use (see Sect. 24.4.21). The pharmacy can help those patients by taking the suppositories out of the forms and package them in ajar. 

Some of the requirements contradict each other, so it is difficult to meet all the requirements. To protect against light non-transparent plastic is necessary. A printed text can be read better on a non-transparent plastic. Nontransparent plastic however hinders the possibility to assess the contents of the suppository forms. Pharmacy-filled suppository strips therefore often have a layer of transparent plastic on one side and a layer of non-transparent plastic on the other side. The secondary container should thus protect against light if necessary. 

Suppository strips for pharmacy preparations often consist of aPVC-polyethylene laminate PVC has the advantage that it shows relatively little permeability to water vapour and oxygen. It has the disadvantage that it always contains softeners that could migrate into the suppository. In the case of polyethylene the permeability to water vapour is comparable to that of PVC, but the permeability to oxygen is greater. The used polyethylene does not release additives. 

Taping up the suppository strip on the upper side with pre-printed tape a disadvantage of the use of tape is that the patient has to cut the suppository forms with scissors to prevent the tape being removed from the whole strip. 

Taping up the suppository strip on the upper side using paper labels with printed text the advantage compared to the method described before is that paper is more easy to tear as a result of which identification per suppository is still possible. 

Suppository strips used for pharmacy preparations usually contain 12 suppository forms per strip. They are available in the volumes of 1.15 mL (for small children), 2.3 mL and 2.8 mL. Although other plastics are possible, many suppository strips are made of PVC-polyethylene laminate the PVC-layer is situated on the outside of the forms and has a thickness of 95 pm, the polyethylene layer is situated on the suppository side of the forms and has a thickness of 75 pm. 

The suppository forms are opened with the peel-off method at one side of the suppository form there are two flaps that can be hold between thumb and forefinger. By tearing the flaps apart the form is opened on the sealed seam. Quality control on incoming suppository strips should include checks on fill volume, ease of opening and contamination. 

As a secondary packaging for the suppository strips carton folding boxes are available. The format 115 x 19 x 55 mm is made for 1-2 strips of 6 suppositories the format... 

For each raw material that should be weighed or measured, the needed quantity is listed on the BPI. Excipients which are required on more than one occasion during preparation, may be mentioned separately each time they are needed in the required amount. Also the quantities of the required packaging materials are Usted, such as the number of suppository strips. 

Opening a package in the right way may require explanation (e.g. eye drop bottles, suppository strips, orally disintegrating tablets). Sometimes a user may prefer a specific container, for instance a jar instead of a tube for ointments. 

Shelf life of pharmacy preparations depends on the character and stability of the preparation and has a maximum of 3 years as is explained in Sect. 22.7.1. Generally, physically and chemically stable suppositories have an expiry date of 3 years after preparation, both in strips in a carton or without strip in a jar. It may be convenient to split up this period in 24 months in the pharmacy and 12 months for use by the patient. 

Section 37.3 gives the general requirements for labelling. There should be a clear indication how to use the dosage form, for instance for rectal use or (rectal) suppositories as well as how to take a suppository out of the plastic strip. This requires some expertise and strong hands as well. 

After the active substance and excipients have been dispersed in and completely mixed with the suppository base the mass should be poured into the molds. The molds can be filled serially (one by one) or simultaneously (all cavities at once). For serial filling usually plastic strips are used (Fig. 11.3). When using a composite metal mold with cadre or a bearer with a number of strips, 100 cavities can be filled simultaneously. Such metal molds are composed of 10 elements of 10 cavities. Once fixed together a cadre is placed over the mold (Fig. 11.6) and aU the mass is poured out at once. 

Fig. 11.6 Suppository molds composite metal mold with cadre for 50 suppositories (a and b) disposable plastic strip for 12 suppositories of ca...

Pessaries originally are egg-shaped. Other shapes are available as well. In pharmacy practice often suppository type molds are used. Alternatively plastic pessary molds may be used (strips). The volume of these egg-shaped molds is about equal to a suppository of 2.8 mL. Formerly used metal pessary molds had a volume of 5 mL. In literature the size of pessaries varies weight values between 1.2 and 6.8 g are found [8s]. No studies are available about a desirable volume. For a local effect 2.8 mL seems to be right For a systemic effect a smaller volume is probably adequate. 

Suppositories and pessaries that are not filled directly in strips (their primary container) if necessary suppositories can first be packaged separately in aluminium foil... 

A jar can be used as secondary container for single dose oral powders in powder paper or sachets, and for suppositories and pessaries in strips. 

Suppositories in strips are dispensed in a cardboard folding box or in glass or plastic jar (see Sect. 24.4.7). 

To identify suppositories in strips the following options can be considered ... 

X 37 X 55 mm is made for 3-4 strips of 6 suppositories. On the reverse side of the specialised folding boxes there are instmctions on how to open the suppository forms. 

Suppositories in strips pose an impossible barrier to patients with limited hand function. The container is too small to... 

A number of holders for strips of plastic suppository molds, optionally with an automated transport mechanism and a foot switch... 

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