Other Dosage Forms

Topical preparations, like all other dosage forms, must be formulated, manufactured, and packaged in a manner that assures that they meet general standards of bioavailability, physical (physical system) stability, chemical (ingredient) stability, freedom from contamination, and elegance. Like all other pharmaceuticals, these factors must remain essentially invariant over the stated shelf life of the product and they must be reproducible from batch to batch. 

Concern for the physical and chemical integrity of topical systems is no different than for other dosage forms. However, there are some unique and germane dimensions to stability associated with semisolid systems. A short list of some of the factors to be evaluated for semisolids is given in Table 12. All factors must be acceptable initially (within prescribed specifications), and all must remain so over the stated lifetime for the product (the product s shelf life). 

Issues similar to those discussed above for other dosage form types arise from the active ingredients and excipients proposed for use. 

Intravenous (i.v.) solutions are commonly administered to patients in hospitals, long-term care facilities, and ambulances. They are used primarily to replace body fluids and to serve as a vehicle for injecting drugs into the body. The advantages of this pharmaceutical dosage form include the rapid onset of action, the ability to treat patients unable to take medication orally and the ability to administer a medication unavailable in any other dosage form. 

Hi) If the other ingredients of tablets, injections or other dosage forms are not completely removed from the substance being examined, they may contribute to the spectrum. 

In addition, eertain eompendial requirements for content and delivered dose uniformity should be measured. The USP and EP propose that the total aerobic count not exceed 100 CFU/g (colony-forming imits) that the total yeast and mold counts not exceed 10 CFU/g and that no specific pathogens be detectable. Specifications for the other attributes should be based on the intended use and the historical performance of the product. As with other dosage forms, specifications must be met throughout the intended shelf life of the product. 

One of the main disadvantages of depot parenteral preparations is that administration of these preparations may not be acceptable to the patient. The depot preparation requires a lower dosing frequency when compared with other dosage forms. 

Q91 Other dosage forms available for the same line of treatment include ... 

Therapeutic results should be seen after 2 to 3 weeks, but may not be optimal until after 6 weeks. Once lesions have responded satisfactorily, maintain therapy with less frequent applications or other dosage forms. 

Liquid oral antidiarrhoeals or any other dosage form for paediatric use containing diphenoxylate or atropine or belladonna including their salts and esters or metabolites, hyoscyamine or their extracts or their alkaloids. 

Liquid oral antidiarrhoeals of any other dosage form for paediatric use containing halogenated hydroxyquinolines. 

It is clear that if these aspirational E factor targets are to be met, then improvements are desirable in many areas of chemistry, including waste minimization in medicinal chemistry, greener synthetic methods in primary manufacture, increased use of chemo and biocatalysis, and more collaborative efforts between pharmaceutical companies. These areas are aU discussed in the remainder of this chapter. Although Sheldon focused on primary manufacture, it is also important to think about secondary manufacture (formulating tablets, capsules, or other dosage forms), which is also covered in this chapter. 

In this chapter, the uses of cosolvents are discussed with some speciLc limitations. The discussion is limited to the cosolvent effects on solubility and stability, their use in parenteral products. For information on the use of cosolvents in other dosage forms such as soft gelatin capsules, the reader is referred to the speciLc chapter in this book on the topic. 

While the transdermal drugs offer the aforementioned advantages, their development, manufacture, and eventual validation also offer perhaps a bit more of a challenge than other dosage forms. In conjunction with the greater overall challenge, some noteworthy disadvantages are that... 

Device development for powder injection also may gain much more momentum with the successful market introduction and penetration of a first product, most likely a hepatitis B vaccine. Of course, this product has to compete with other dosage forms and has to prove superiority to gain acceptance and become more than a niche product. Multiple-dose devices for powder injection probably will take much longer to market. Similar to inhalation devices, such systems will require advanced features such as dose counting and logbook functions. 

A colorimetric method for the analysis of etodolac has been reported which is based on the formation of colored complexes with p-dimethyl-aminobenzaldehyde in the presence of sulfuric acid and ferric chloride [19]. Absorbance measurements were made at 591.5 nm, and the method was found to be linear over the concentration range of 10 to 80 pg/mL. This method was used to determine etodolac in bulk powder and other dosage forms. 

Year No. of Tablets No. of Capsules Approved Injectable Dosage Forms Approved No. of Other Dosage Forms Approved Percentage of Approved Tablets and Capsules (%)... 

Parenteral delivery systems involve the use of needles. This is painful for the patient, as well as generally requiring the intervention of medical professionals. The oral route, which involves merely swallowing a tablet, liquid or capsule, thus represents a much more convenient and attractive route for drag delivery. Transdermal patches are also well accepted by patients and convenient. Some other dosage forms, for example nebulizers, pessaries and suppositories, may meet with more limited patient compliance. 

A brief description of the pharmacokinetic characteristics of the active ingredient(s) and the performance of the dosage form, integrating conclusions from the bioavailability and pharmacokinetic studies and from clinical studies performed. Information on volume of distribution, half-life, routes and rates of excretion, and metabolism of each dosage form studies, and the proportionality of absorption over the therapeutic dose range should be included. If pertinent, a comparison with the bioavailability of other dosage forms should be provided. 

Dissolution rate tests for tablets, capsules, suspensions, suppositories, or other dosage forms. Controlled-release dosage forms or drug delivery systems also should be monitored by appropriate testing methodology. 

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