Liquid oral dosage forms

The techniques for predicting the chemical stability of homogeneous drug systems are well defined. " The formulation chemist should consider both the pH-solubility profile and the pH-stability profile when selecting the optimum pH for formulation of the liquid oral dosage form. For example. Figs. 3 and 4 show the... 

Sweeteners are indispensable components of many liquid oral dosage forms, especially those containing bitter or other unacceptable tastes. In fact, sweetening agents may comprise large portions of solid content in most liquid oral dosage forms. Sweeteners are often classified as either nutritive (caloric) or non-nutritive... 

Polypropylene (PP) containers are suitable for packaging dry solid or liquid oral... dosage forms. 

Is the drug a liquid oral dosage form only PET/PETG... 

The average number of recalls per annum for microbial contamination of non-sterile pharmaceutical and OTC drug products is six (Table 4). The emphasis on waterborne Gram-negative bacteria of the species Bulkholderia (Pseudomonas) cepacia (nine recalls), P. putida (three recalls), P. aeruginosa (three recalls). Pseudomonas spp. (two recalls), and Ralstonia (P.) pickettii (one recall) is notable and reflects the concern for bacteria capable of growth in liquid oral dosage forms that overwhelm the preservative system. 

Given the complexity of some of the dosage forms mentioned earlier, this guidance was limited to solid oral dosage forms, liquid oral dosage forms, and parenterals (small and large volume). These products serve as models, and the principles applied can be used for all other dosage forms such as inhalation products, topical formulations, and transdermal systems. 

Applicability All plastics Dry oral dosage forms Liquid oral... 

Oral Administration. Oral administration is the preferred route of administration. There is a general consensus among pediatricians and parents that children younger that 5 years of age have great difficulty with, or are unable to swallow, a solid oral dosage form. Manufacturers, therefore, have developed liquid formulations for many of the commonly used pediatric products. The liquid dosage form, however, is not free of problems. Liquid products are often unstable and have short expiration dates accurate measurement and administration of the prescribed dose is also a problem, especially in infants. 

The dosage forms most commonly employed for pediatric formulations are liquids and chewable tablets. A perceived unpleasant taste is much more evident with these dosage forms than when a drug is administered as a conventional solid oral dosage form. Second, it is widely believed that children younger than the age of 6 years have more acute taste perception than older children and adults. Taste buds and olfactory receptors are fully developed in early infancy. Loss of taste perception accompanies the aging process. 

Solid oral dosage forms, particularly tablets, are the preferred type of formulation in the United States. Not only are these products widely accepted by consumers, but they are also relatively cheaper to develop and manufacture than oral liquids or suspensions, par-enterals, or suppositories. Figure 4 shows, quite clearly, that even the elderly primarily make use of solid oral dosage forms [162]. 

M. J. Dubber, V. Sewram, N. Mshicileli, G.S. Shephard and I. Kanfer, The simultaneous determination of selected flavonol glycosides and aglycones in Ginkgo biloba oral dosage forms by high performance liquid chromatography electrospray ionization mass spectrometry, J. Pharmaceut. Biomed., 37, 723 731 (2005). 

A changing an adult oral dosage form to a liquid formulation for administration to a paediatric patient... 

The dry powders that are reconstituted in their marketed container need not be sterile however, the possibility of an interaction between the packaging components and the reconstituting fluid can t be discarded. Although the contact time will be relatively short when compared to the component/dosage form contact time for liquid-based oral dosage forms, it should still be taken into consideration when the compatibility and safety of the container closure system are being evaluated. 

Liquid-based oral drug products are usually dispensed in glass bottles (sometimes in plastic), often with a screw cap with a liner, and possibly with a tamper-resistant seal or an overcap that is welded onto the bottle. The same cap liners and inner seals are sometimes used with solid oral dosage forms. A laminated material can be used to overwrap glass bottles for extra safety. 

Nonsolids Typical liquid-based oral dosage forms are elixirs, emulsions, extracts, fluid extracts, solutions, gels, syrups, spirits, tinctures, aromatic waters, and suspen-... 

---