Oromucosal preparations

The Ph. Eur. describes mouthwashes and gargles in the monograph on Oromucosal Preparations (Praeparationes... 

Semisolid preparations are hydrophilic gels or pastes intended for application in the oral cavity or a specific location like the gums (gingival) or the teeth (dental). According to the Ph. Eur. these semisolid oromucosal preparations comply with the requirements for semisolid preparations for cutaneous use. 

This section focuses on the design of the formulation of oromucosal preparations. Design and excipients are described, in liquid, semisolid and solid dosage forms respectively. 

The preparation of semisolid oromucosal preparations is the same as that of cutaneous preparations (see Sect. 12.6). The same is true for the in process controls. 

An allergen preparation has been administered via direct ingestion (oral route) or by so-called mucosal routes nasal, sublingual or oromucosal. This implies that some local effects or local absorption were expected. As a matter of fact, a demonstration of the clinical efficacy of mucosal allergen immunotherapy has been provided, and some hypotheses about its mechanism of action have been formulated [15-19,24-32],... 

For local but also systemic delivery, the oromucosal route might be suitable if safety is established. Mucoadhesive preparations, especially films, semi-solids and liquids, might be of interest if they do not interfere with suction and frequent feeding. Nevertheless, one of the major issues remains the taste of the preparation and the willingness as well as the ability of the child to retain buccal or sublingual tablets in the mouth, thus ensuring that sufficient absorption takes place. 

For the preparation of oromucosal solutions and gargles the active ingredients and the excipients are dissolved in the (mixture of) solvent(s) (see Sect. 5.5.2). 

Oromucosal suspensions are prepared in the same way as suspensions for cutaneous use (see Sect. 12.7.3). So also for in-process controls reference is made to those chapters. 

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