Oral Powders for Reconstitution

Oral powders should be evaluated for appearance, odor, color, moisture, and reconstitution time. 

Reconstituted products (solutions and suspensions) should be evaluated as described in Section VIII.D, after 

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GRAS listed. Accepted for use as a food additive in Europe. Included in the FDA Inactive Ingredients Guide (oral powder for reconstitution, buccal patch, granules, film-coated, and tablets). Included in nonparenteral medicines licensed in the UK. Included in the Ganadian List of Acceptable Non-medicinal Ingredients. 

Enteral nutrition (EN) is broadly defined as delivery of nutrients via the gastrointestinal (GI) tract. This could include normal oral feeding as well as delivery of nutrients in a liquid form by a tube. Sometimes when the term enteral nutrition is used, only tube feedings are included hence the terms enteral nutrition and tube feedings are often used synonymously. The bulk of this chapter will include information regarding delivery of feedings via tubes. Formulas for EN usually are delivered in the form of commercially prepared liquid preparations, although some products are produced as powders for reconstitution. 

Rotarix consists of live, attenuated rotavirus strains presented os powder for reconstitution intended for oral administration. 

Oral powder- The oral powder may be mixed with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplement once mixed, the entire contents must be consumed in order to obtain the full dose. Acidic food or juice (eg, orange juice, apple juice, or apple sauce) are not recommended because of bitter taste. Do not reconstitute with water in its original container. Once mixed, store the oral powder for no more than 6 hours. May be refrigerated for up to 6 hours. 

Powder for Reconstitution, Oral Viokase]-. 70,000 units-16,800 units-70,000 units/0.7 g. 

G. Solid Oral Dosage Forms and Powders for Reconstitution... 

For solid oral dosage forms, a reference to the appropriate indirect food additive regulation for each material of construction is typically considered sufficient evidence of safety. However, for a powder for reconstitution dosage form, reference only to the indirect food additive regulations as evidence of safety for the materials of construction is not recommended. Compatibility for solid oral dosage forms and for powders for reconstitution is typically addressed for plastics and glass by meeting the requirements of the Containers test. 

Many oral solutions are intended for pediatric administration, of which oral solution formulations are a subset of a larger choice of formulation type such as suspension, syrup, powder or microcapsules for constitution to a suspension, powder for reconstitution to a solution or suspension, solid particles (powder, coated particles, extended release, enteric-coated granules, beads) in packets or capsules to be sprinkled on food, oral powders, and chewable tablets. The broader topic of pediatric formulation development is beyond the scope of this chapter, but this chapter will cover selected oral solutions for pediatric administration. 

An antibiotic for oral suspension, following reconstitution of the dry powder, contains in each 5 mL, 250 mg of the drug in package sizes to prepare 100 mL, 150 mL, or 200 mL of suspension. Which package size should be dispensed for a 20-kg child prescribed to take 50 mg/kg/day total, q.i.d. in divided doses, for a period of 10 days ... 

Powder for oral suspension 125 and 250 mg/5 mL (as trihydrate) when reconstituted (Rx)... 

Oral 250, 500 mg tablets powder to reconstitute for 125, 250 mg/5 mL solution Piperacillin (Pipracil)... 

Oral 20, 50, 75, 100 mg tablets and capsules powder to reconstitute for 25 mg/5 mL suspension 50 mg/5 mL syrup Parenteral 100, 200 mg powder to reconstitute for injection Minocycline (generic, Minocin, various)... 

Oral (ethylsuccinate) 400 mg tablets 200, 400 mg/5 mL suspension Oral (stearate) 250, 500 mg film-coated tablets Parenteral lactobionate, 0.5, 1 g powder to reconstitute for IV injection... 

Aerosol (Virazole) powder to reconstitute for aerosol 6 g/100 ml vial Oral (Rebetol, generic) 200 mg capsules, tablets 40 mg/mLoral solution Oral (Rebetron) 200 mg in combination with 3 million units interferon alfa-2b (Intron-A) Rifabutin (Mycobutin)... 

Oral 250 mg capsules 500 mg tablets 200 mg powder for suspension 180, 360 mg delayed-release tablets Parenteral 500 mg powder reconstitute for injection Omalizumab (Xolair)... 

Oral 10 mg tablets, gelcaps powder to reconstitute for 40 mg/5 mL suspension Parenteral 10 mg/mL for injection Nizatidine (generic, Axid, Axid AR )... 

Powders for Oral Solutions and Suspensions Water content, reconstitution time, and reconstituted solutions and suspensions should be tested as above for oral solutions and suspensions. 

The most common solid oral dosage forms are capsules and tablets. For the purpose of this guidance, oral powders and granules for reconstitution are also included in this group. 

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