Oral route of administration

Use the oral route of administration if the patient has mild nausea with minimal or no vomiting. Seek an alternative route (e.g., transdermal, rectal suppository, or parenteral) if the patient is unable to retain oral medications due to vomiting. 

Historically, the oral route of administration has been used the most for both conventional and novel drug-delivery systems. There are many obvious reasons for this, not the least of which would include acceptance by the patient and ease of administration. The types of sustained- and controlled-release systems employed for oral administration include virtually every currently known theoretical mechanism for such application. This is because there is more flexibility in dosage design, since constraints, such as sterility and potential damage at the site of administration, axe minimized. Because of this, it is convenient to discuss the different types of dosage forms by using those developed for oral administration as initial examples. 

Toxicity of diazinon to laboratory animals via dermal, inhalation, dietary, and chronic oral routes of administration... 

Table 16.5 Toxicity of Diazinon to Laboratory Animals via Dermal, Inhalation, Dietary, and Chronic Oral Routes of Administration...

No information is available regarding the effects of acute-duration exposure to chlordecone in humans following inhalation, oral, or dermal exposure. Some information is available regarding the effects of acute-duration exposure to chlordecone in animals by the oral route of administration (Cannon and Kimbrough 1979 Chernoff and Rogers 1976 Davis and Mehendale 1980 Desaiah... 

Interroute Extrapolation. Inhalation and oral routes of administration were examined in the Reitz model however, interroute extrapolations were not specifrcally addressed in the Reitz model. 

Exposure for at least 28 days At least three dose levels plus control At least eight animals per group Preferred species Rats and/or mice Generally oral route of administration... 

Despite reports to the contrary (P2), lignocaine is not therapeutically effective when given orally and does not achieve satisfactory blood levels when these are measured by specific techniques. Moreover, since the oral route of administration is associated with an unacceptably high incidence of side effects, which are probably due to metabolites of lignocaine rather than to the drug itself, this mode of administration has not gained widespread acceptance. 

The use of food additive petitions and GRAS procedures to evaluate the safety of a proposed new excipient would apply to the oral route of administration for the excipient and would not generally apply to other routes of administration. Some routes of administration (e.g., inhalation) result in unique toxicological requirements, and data would have to be developed for the specific route of administration. While toxicological data from systemic studies are important for excipients used for nonoral applications, separate data would be needed for the specific route of administration. Nevertheless, the amount of safety data, specifications, and intake information required for a food additive review is extensive, and therefore could provide a firm basis of safety for a new excipient. 

In conclusion, the JECFA evaluation process for food additives is a thorough, comprehensive review of safety, intake, and specifications resulting in an assignment of an ADI. An evaluation by JECFA could serve as a credible review of the safety of a new excipient. Likewise, the safety evaluation by FDA or the EFSA of an ingredient for use as a food additive could also be very useful to support the potential use of a new excipient for the oral route of administration. 

Goals of the injectable route of administration, versus oral route of administration, for example, are several fold (1) ... 

This calculation illustrates a couple of additional points. First, the MACO calculation will utilize different LDS0 values, depending on the route of administration of the other products manufactured in the same equipment. If all of the products manufactured in the equipment were used by the oral route of administration, then the limit used would be 19.6 g. If any of the products made in the same equipment were to be eventually incorporated into an IV dosage form, however, then the limit would be 119 mg (i.e., the more conservative of the two calculations). 

Vitamin B12 is available in pure form for oral administration or in combination with other vitamins and minerals for oral or parenteral administration. The choice of a preparation always must be made with recognition of the cause of the deficiency. Although oral preparations may be used to supplement deficient diets, they are of relatively little value in the treatment of patients with deficiency of intrinsic factor or ileal disease. Even though small amounts of vitamin B12 may be absorbed by simple diffusion, the oral route of administration cannot be relied upon for effective therapy in the patient with a marked deficiency of vitamin B12 and abnormal hematopoiesis or neurological deficits. Therefore, the preparation of choice for treatment of a vitamin B12-deficiency state is cyanocobal-amin, and it should be administered by intramuscular or deep subcutaneous injection. 

For the oral route of administration the dose was selected according to the experience from the FIM study, where this dose was safe and well tolerated and was in the dose-proportional range. The dose for the intravenous route of administration was adjusted according to the results from animal bioavailability studies where the absolute bioavailability was in the range of 50%. 

BZ is active when it is given by the intravenous, intramuscular, inhalation, or oral route of administration. The fragmentary data available indicate that the higher dose caused the greatest effects and longest duration. From 1960 to 1969, field tests had been conducted with 3-quinuclidinyl benziiate by the US Army. Sidell s (1982) description of the effects induced by BZ (4.5-17.1 pg/kg) is as follows. 

When patients can swallow, the oral route of administration is preferred because of its simplicity, analgesic efficacy, and convenience. 

The oral route of administration should be used whenever possible. 

The oral route of administration yields adequate clinical angiograms in approximately 97% of cases and has the advantage that side effects are rare. 

Deeper or more severe forms of uveitis may not respond to topical therapy hence, injectable and/or oral routes of administration may be required. Periocular corticosteroids may be used occasionally for anterior uveitis however, this therapy is more often used in cases of intermediate uveitis or, less commonly, unilateral posterior uveitis.A small amount of depot corticosteroid (e.g., 1 ml of 40 mg/ml triamcinolone acetonide injected superiorly or inferiorly in the orbit) is considered acceptable and appropriate treatment in such situations. In cases of chronic posterior uveitis or uveitis associated with CME, intravitreal triamcinolone has also been used with some success. A retrospective study in 2005 demonstrated that intravitreal injection of 4 mg/0.1 ml triamcinolone acetonide can effectively reduce CME and improve visual acuity and, in some eyes, allow for the reduction of immimosuppressive therapy. 

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