Dosage forms solution formulations

The physiochemically and biologically characterized proteins and peptides are further formulated and subject to stability studies. The goal of these studies is to develop a unique combination of excipients, solution pH, buffer, and container that will produce an optimum dosage form. Biopharmaceutical formulations should be... 

SVIs are simple formulations compared with other pharmaceutical dosage forms. Solution SVIs contain water, the active ingredient, and a minimal number of inactive added ingredients. Solid SVIs contain the active ingredient and usually one or two added ingredients. Formulation scientists have severe restrictions in number and choice of added substances because of safety considerations. 

Formulation characteristics such as the particle size, surface area, crystal form, and dosage forms (solution, tablet, capsule, suspension, emulsion, gel, and modified released)... 

Please note that since peak time is independent of the dose administered, for a 500 mg tablet, the peak time will be identical (i.e. 0.971 h or 58.25 min). However, if an identical dose or even a different dose of procainamide is administered through a different extravascular route (e.g intramuscular), different dosage form (e.g. solution, capsule, controlled release tablet) or different formulation (e.g. tablet made by a different manufacturer or the same manufacturer with a different formulation), the peak time may be different. This is because the absorption rate constant may change with route of administration, dosage form and formulation. 

Liquid Dosage Forms. Simple aqueous solutions, symps, elixirs, and tinctures are prepared by dissolution of solutes in the appropriate solvent systems. Adjunct formulation ingredients include certified dyes, flavors, sweeteners, and antimicrobial preservatives. These solutions are filtered under pressure, often using selected filtering aid materials. The products are stored in large tanks, ready for filling into containers. QuaUty control analysis is then performed. 

As mentioned earlier in this chapter, penicillins are very unstable in aqueous solution by virtue of hydrolysis of the p-lactam ring. A successful method of stabilizing penicillins in liquid dosage forms is to prepare their insoluble salts and formulate them in suspensions. The reduced solubility of the drug in a suspension decreases the amount of drug available for hydrolysis. An example of improved stability of a... 

Vries et al. [3.59] described the development of a stable parenteral dosage form of the cytotoxic drug E 09. E 09 dissolves poorly in water and its solution is unstable. With the addition of 200 mg of lactose per vial containing 8 mg of E 09, an optimum formulation was developed with respect to solubility, dosage of E 09 and length of the freeze drying cycle. DSC studies have been used to select the most effective parameters. The freeze dried product remains stable for 1 year when stored at 4 °C in a dark environment. 

Numerous reports concerning the stability of neomycin in various dosage forms have been published. Simone and Popino298 studied the stability of neomycin in liquid dosage forms such as nasal drops, mouth washes and tinctures. The antibiotic was stable in all the formulations tested, except Dobells solution (a mouth wash), for at least 6 months at 20°C. Some formulations were stable for considerably longer. 

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Many drugs are administered as parenterals for speed of action because the patient is unable to take oral medication or because the drug is a macromolecule such as a protein that is unable to be orally absorbed intact due to stability and permeability issues. The U.S. Pharmacopoeia defines parenteral articles as preparations intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal. They include intravenous, intramuscular, or subcutaneous injections. Intravenous injections are classified as small volume (<100 mL per container) or large volume (>100 mL per container) injections. The majority of parenteral dosage forms are supplied as ready-to-use solutions or reconstituted into solutions prior to administration. Suspension formulations may also be used,101 although their use is more limited to a subcutaneous (i.e., Novolin Penfill NOVO Nordisk) or intramuscular (i.e., Sandostatin LAR Depot Novartis) injection. Intravenous use of disperse systems is possible but limited (i.e., Doxil Injection Ortho Biotec). 

Buccal dosage forms can be of the reservoir or the matrix type. Formulations of the reservoir type are surrounded by a polymeric membrane, which controls the release rate. Reservoir systems present a constant release profile provided (1) that the polymeric membrane is rate limiting, and (2) that an excess amoimt of drug is present in the reservoir. Condition (1) may be achieved with a thicker membrane (i.e., rate controlling) and lower diffusivity in which case the rate of drug release is directly proportional to the polymer solubility and membrane diffusivity, and inversely proportional to membrane thickness. Condition (2) may be achieved, if the intrinsic thermodynamic activity of the drug is very low and the device has a thick hydrodynamic diffusion layer. In this case the release rate of the drug is directly proportional to solution solubility and solution diffusivity, and inversely proportional to the thickness of the hydrodynamic diffusion layer. 

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