Effective Rectal Dosage Forms for Smooth Commercialization
Although the oral route of drug product administration is by far the most convenient and widely used approach today, there are circumstances where this is not possible from either a pharmaceutical or clinical point of view. The rectal dosage pathway is a flexible alternative format developed by the pharmaceutical industry which is, for the most part, inexpensive to manufacture, and easily self-administered by patients, without the need for medical staff intervention.
The rectal route is used to administer a variety of medications for both local (e.g. constipation, hemorrhoids, inflammation and hyperkalemia) and systemic treatments (e.g. pain, fever, nausea and vomiting, migraines, allergies and sedation), and is particularly useful in cases where oral administration is not possible, such as for patients who are unable to swallow or experiencing nausea and vomiting.
This highly convenient and practical dosage form can be categorized into three groups: liquids (e.g. enemas), solids (e.g. suppositories, capsules or tablets) and semi-solids (e.g. gels, foams and creams). Our state-of-the-art drug product facilities offer development and manufacturing services in all three classes of products, with extensive capabilities in particular for enemas and suppositories.
Non-Sterile Specialty Rectal Dosage Forms
In the area of non-sterile specialty dosage forms, we offer the following rectal dose services for all phases from clinical development through to commercialization.
Enemas
Enemas are liquid dosage forms for rectal drug delivery that contain medications either in solution, suspension or emulsion, typically administered from disposable plastic squeeze bottles with special tips for rectal insertion.
For systemic drug delivery, certain medications such as some anti-epileptic drugs or hormone replacement therapies can be formulated as enemas to achieve systemic absorption through the rectal mucosa.
Suppositories
Suppositories are the most common rectally administered dosage form. They are solid forms containing drugs that are either dispersed or dissolved in a suitable mixture of excipients that can either be lipophilic or hydrophilic, depending upon the excipients used in manufacturing and the desired release and absorption profile.
Rectal suppositories are commonly used to treat conditions such as constipation, hemorrhoids, or inflammation in the rectal area. They can also be used to administer medications such as antiemetics or antipyretics, when oral administration is not feasible or effective.
For systemic drug delivery, certain medications such as some anti-epileptic drugs or hormone replacement therapies can be formulated as rectal suppositories to achieve systemic absorption through the rectal mucosa.
Rectal Dosage Form Packaging
Our equipment and specialized packaging technologies for rectal dosage forms include:
- Primary & secondary packaging
- Automated suppository filling line
- Automated enema filling line
- Online labeling, documentation & tracing of vignettes
- Inkjet printing
- Tamper evident packing
- Serialization & aggregation
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