Oral solution

On occasion amphotericin B may be administered as an oral solution for oral candidiasis. The patient is instructed to swish and hold the solution in the mouth for several minutes (or as long as possible) before swallowing. The oral solution may be used for as long as 2 weeks. 

The oral solution is available in a concentration of 40 mg/5 mL. The nurse administers. ... 

The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy, in which case additional safety and efficacy data are required. The same qualitative and quantitative composition only applies to the active ingredients. Differences in excipients will be accepted unless there is concern that they may substantially alter the safety or efficacy. The same pharmaceutical form must take into account both the form in which it is presented and the form in which it is administered. Various immediate-release oral forms, which would include tablets, capsules, oral solutions and suspensions, shall be considered the same pharmaceutical form for this purpose. 

Bolla KI, McCann UD, Ricaurte GA Memory impairment in abstinent MDMA ( ecstasy ) users. Neurology 51 1532—1537, 1998 Borgen L, Lane E, Lai A Xyrem (sodium oxybate) a study of dose proportionality in healthy human subjects. J Clin Pharmacol 40 1053, 2000 Borgen LA, Okerholm R, Morrison D, et al The influence of gender and food on the pharmacokinetics of sodium oxybate oral solution in healthy subjects. J Clin Pharmacol 43 59-65, 2003... 

Diphenoxylate/atropine Adults Two tablets (5 mg) initially, then one tablet every 3-4 hours, not to exceed 20 mg in 24 hours Children 2-12 years old Oral solution (avoid tablets) 0.3 to 0.4 mg/kg per day in divided doses Do not administer to children less than 2 years of age Acute and chronic... 

Ziprasidone Risperdal Consta Geodon 1, 2, 3, 4 mg Oral solution 1 mg/mL Long-acting injectable 25, 37.5, 50 mg Capsule 20, 40, 60 80 mg 40-160 mg/day in divided doses is not approved at present for bipolar disorder... 

Ti me to reach peak serum concentrations Distribution 0.5-3 hours (regular-release) 4-12 hours (extended-release) 0.25-1 hours (oral solution) 4.5 hours (regular-release) 1.5 hours (suspension) 3-12 hours (extended-release tablets) 4.1-7.7 hours (extended-release capsules) higher peak concentrations with chewable tablets 4.5 hours (range of 3-13 hours) 1 -4 hours (VPA) 3-5 hours (DVPX single dose) 7-14 hours (DVPX extended-release multiple dosing) 1 -4 hours... 

Drugs that should not be combined due to overlapping toxi-cities include amprenavir oral solution plus ritonavir oral solution, atazanavir plus indinavir (due to enhanced hyperbilirubinemia), and any combination of didanosine, stavudine, and zalcitabine. Emtricitabine and lamivudine should not be combined because of their similar chemical structures, and antagonism can result when lamivudine is combined with zalcitabine, or stavudine is combined with zidovudine. 

Emtriva oral solution (24 mL) oral 30-19 200 mg q48hours 120 mg q24hours ... 

Zidovudine (AZT, ZDV) Retrovi r 1 00-mg caps, 300-mg tabs, 1 0 mg/mF intravenous solution, 1 0 mg/mF oral solution 300 mg bid 1 00 mg tid in severe renal impairment or HD None Bone marrow suppression macrocytic anemia or neutropenia gastrointestinal intolerance, headache, insomnia, asthenia Glucuronyl transferase and renal... 

Note APV and RTV oral solution should not be co-administered due to competitioi of the metabolic pathway of the two vehicles)... 

Oral solution not recommended in patients with renal oral hepatic failure... 

LPV/r) Kaletra RTV 50 mg tablet, LPV 400 mg + RTV 1 00 mg/5 mL oral solution (contains 42% alcohol) bid 4 tablets qday With EFV or NVP 3 tablets or 6.7 mL bid with hepatic impairment T 48-80%) asthenia hyperlipidemia LFT elevation hyperglycemia fat maldistribution increased bleeding episodes in hemophiliacs and susbstrate... 

Whenever a drug is administered by an extra-vascular route, there is a danger that part of the dose may not reach the blood (i.e., absorption may not be complete). When the intravenous route is used, the drug is placed directly in the blood therefore an IV injection is, by definition, 100% absorbed. The absolute bioavailability of an extravascular dosage form is defined relative to an IV injection. If IV data are not available, the relative bioavailability may be defined relative to a standard dosage form. For example, the bioavailability of a tablet may be defined relative to an oral solution of the drug. 

The purpose of in-use stability studies is to establish the period for which a product intended to be used on more than one occasion may be used after reconstitution or dilution or the withdrawal of the first dose from the container without adversely affecting the integrity of the product and with the product retaining acceptable quality characteristics. This type of test can be applied to any multiple use product (e.g., sterile products in multiple-use containers, powders or granules including those used to produce oral solutions or suspensions) but is likely to be of particular importance in the case of products that are manufactured with an inert headspace gas, for products containing antioxidants to protect an active ingredient that is liable to oxidative decomposition, and for products that contain a volatile antimicrobial preservative. 

Comparative bioavailability data are discussed where a number of different dosage forms/routes of administration have been used during the development process, e.g., tablets, capsules, oral solutions, granules, and injections. 

A number of oral solution or suspension products are included in the EPARs. Apart from the usual points of consideration for active ingredients and excipients, particular mention is made of possible precipitation of active ingredient when a solution is in use, the inclusion of excipients having a major impact on bioavailability, the need for flavoring to mask the taste of the active ingredient, relative potency compared with other routes of administration, preservation issues, dosing devices and the precision and accuracy of the dose delivered, and bioequivalence where formulations have been modified during the development process. 

Concentrated Oral Solutions. Presentation of a drug may be made in the form of a concentrated solution that allows the entire dose to be held within a volume of less than 5 mL (e.g., Intensol Concentrated Oral Solutions, Roxanne). This opens up another means of providing medication to the aged, infants, or any other patients experiencing difficulties swallowing. Such preparations can be mixed with food or drink. Taste and poor solubility are problems that may set limits on the number of successful formulations that can be prepared in this way. Also, small errors in the measurement of such preparations represent large errors in dosing. 

As noted earlier, osmotic systems have been shown to provide good in vitro-in vivo correlations between the observed release rates. This has been shown explicitly for the core I devices described above [33], The data are shown in Figure 16, where the in vitro data are plotted along with the release curves from six devices administered to dogs. The animals were in the fed state at the time of administration and maintained that way throughout the duration of the experiment via the administration of —50 g of dog chow before device administration and every hour thereafter. The individual release curves shown in Figure 16 were obtained by numerical deconvolution of the plasma data with an oral solution dose given to the same dog. Clearly the in vivo and in vitro data are... 

D. O. Thompson, and J. P. Mannermaa. Intestinal safety of water-soluble beta-cyclodextrins in paediatric oral solutions of spironolactone effects on human intestinal epithelial Caco-2 cells,... 

V. P., Thiazides X lack of dose proportionality in plasma chlorothiazide levels following oral solution doses, Curr. Ther. Res. 1982, 32, 379-385. 

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