- Patients may receive an Enteral tube for many reasons, from co-morbidities (multiple diseases/conditions present) to critical care situations like auto accidents.
- If the patient is unable to swallow an oral medication for any reason, other means of administration are necessary.
- Some medications can be temporarily stopped until the patient recovers, but sometimes the patient condition is permanent, or the medicine is too critical to stop therapy, even temporarily.
Enteral Administration for Oral Products
What are Oral Drug Products?
It’s more than likely you have taken an oral drug product in your lifetime. Whether it was an anti-inflammatory for some muscle aches, some form of antibiotic, a liquid for acid reflux, or something else – high chances it was an oral drug product. But what exactly are oral drug products and what happens if you have difficulty taking them the standard route of swallowing? Read on to learn more!
Oral Drug Products
Oral Drug products are the most common form of drug product presentation due to their ease of use and good stability.
Oral drug products are most often developed in the following forms:
- Tablets
- Capsules
- Liquid Solution
- Liquid Suspension
Each oral drug product is developed with a specific mode of delivery in mind. Tablets and Capsules have different uses cases for drug delivery. Additionally liquid solutions and suspensions are delivered in different ways that tablets and capsules. The reason a liquid/suspension is used instead of tablets/capsules can be driven by manufacturability, stability, administration pathway, and various other reasons.
Patients in Need
Enteral Tubes (Passing to Intestine)
Types of Tubes
Enteral tubes are most commonly two (2) types:
- PEG (Percutaneous endoscopic gastrostomy) Tube (through the abdomen)
- NG Tube (Nasogastric tube) through nose
PEG Tube
NG Tube
Administration in Clinical Trials
Now that we’ve learned a bit more about the two main types of enteral tubing, what happens if challenges with oral administration are encountered during clinical trials? The R&D team develops a compliant way to administer the medicine to that patient, however, compliance is the key word! What does that mean? Keep on reading to find out!
Administration Qualification
In past FSF’s we’ve covered process qualification and the importance it has within our Quality System to ensure our manufacturing processes are robust and repeatable, producing high quality and safe product.
The same qualification requirement is there for developing drug administration methods during clinical trials! Before AbbVie can instruct Healthcare Professional (HCPs) on the new administration route, we must conduct testing to qualify the instructions we plan to implement. This testing consists of a series of critical parameters to ensure the product is safe, and the pK/bioavailability of the product is maintained.
Clinical IFUs
Once the new administration method is qualified, AbbVie will develop an Instruction For Use (IFU) to be used in the clinical trial by the HCP. This IFU will provide detailed instruction on how to prepare the medicine in these new ways.
To further support clinical success, AbbVie also develops clinical trial training videos, pamphlets and informational programs, and even provides direct 1:1 training of clinical staff.
In general, these clinical IFUs are critical to ensure patients are receiving their doses correctly, which ensures the accuracy and effectiveness of the trial!
Testing the New Administration Method
To test the new administration method, to main types of testing occur:
Physical Testing – such as evaluating if the drug mixture clogs the tubing.
Chemical Testing – how does the drug/mixture interact with or degrade in the tubing?
These tests are critical to ensure the drug maintains its safety and efficacy. Here, we’ll take a look at how a new administration method may look.
1-2
Minitablets are ground to a fine powder
3-4
Minitablets powder is mixed with water and drawn
into a syringe for administration via enteral tube
