Formulation pediatric

Nahata, M.C. Lack of pediatric drug formulations. Pediatrics 1999, 104 (3 Supplement Part 2), 607 -609. 

Comparable daily doses of PPIs are omeprazole 20 mg = esomeprazole 20 mg = lansoprazole 30 mg = rabeprazole 20 mg = pantoprazole 40 mg. The PPIs degrade in acidic environments and are therefore formulated in delayed-release capsules or tablets.16 Lansoprazole, esomeprazole, and omeprazole contain enteric-coated (pH-sensitive) granules in a capsule form. For patients unable to swallow the capsule or in pediatric patients, the contents of the capsule can be mixed in applesauce or placed in orange juice. If a patient has a nasogastric tube, the contents of an omeprazole capsule can be... 

Adolescents 11 through 15 years of age may receive either the 5 meg, 3-dose pediatric formulation or a 10 meg, 2-dose regimen using the adult formulation. 

Formulate appropriate patient counseling information for patients undergoing drug therapy for urinary incontinence or pediatric enuresis. 

Sweeteners. Sweeteners are commonly included in pediatric formulations to increase palatability. 

Hepatic metabolism of ethanol involves a nonlinear saturable pathway. Young children have a limited ability to metabolize and thereby detoxify ethanol. Ethanol intoxication has been recorded in children with blood levels as low as 25 mg/dL. Alcohol has a volume of distribution of approximately 0.65 L/kg. Ingestion of 20 mL of a 10% alcohol solution will produce a blood level of 25 mg/dL in a 30 pound child. The American Academy of Pediatrics (AAP) Committee on Drugs recommends that pharmaceutical formulations intended for use in children should not produce ethanol blood levels of >25 mg/dL after a single dose. 

Extemporaneous production of pediatric dosage forms is commonly undertaken in hospitals. Without the sophisticated formulation capabilities of pharmaceutical manufacturers, alcohol-based vehicles have been recommended for extemporaneous preparation of liquid dosage forms [73]. There is a critical need to conduct research studies to assist the pharmacist in replacing current formulations with stable, alcohol-free preparations [74]. 

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. 

Effective and safe drug therapy for newborns, infants, and children depends on knowledge of pediatric pharmacokinetics and pharmacodynamics and knowledge of the drug formulation and delivery issues specific to this population. 

The critical void in pediatric drug therapy now lies in effective drug-delivery systems. Some inroads have been made in the manufacturing of pediatric dosing systems, particularly OTC preparations. There needs to be a redirection of the focus in nonparenteral drug formulations towards pediatric dosage forms with proven stability and bioavailability that can be easily and accurately administered to infants and children. 

J. Cloyd, R. Kriel, C. Jones-Sauete, B. Ong, J. Jancik, and R. Remmel, Comparison of sprinkle versus syrup formulations of valproate for bioavailability, tolerance and preference, J. Pediatr., 120, 634 (1992). 

Lombardo S, Santangelo G Therapeutic effectiveness of L 105, given in three pediatric formulations, as an intestinal antibacterial agent. Farmaco (Prat) 1984 39 170-175. 

Suspensions are two-phase systems consisting of a finely divided solid dispersed in a liquid, solid, or a gas (Table 6). They are appropriate when the drug to be incorporated is not sufficiently soluble in an ordinary solvent or cosolvent system. They are used orally and topically. Examples of compounded suspensions include pediatric oral liquids where a commercial pediatric dosage form is not available. Commercial tablets and capsules are formulated into a vehicle and can be individually flavored to the patient s preference. 

Proquin XR Proquin XR and other oral formulations of ciprofloxacin are not interchangeable. Proquin XR should be administered orally once daily for 3 days with a main meal of the day, preferably the evening meal. Proquin XR should be administered at least 4 hours before or 2 hours after antacids containing magnesium or aluminum, sucralfate, Videx (didanosine) chewable/buffered tablets or pediatric powder, metal cations such as iron, and multivitamin preparations containing zinc. Pragy/n XR tablets should be taken whole and never split, crushed, or chewed. 

Didanosine EC (Videx EC) - Didanosine EC has not been studied in pediatric patients. Please consult the complete prescribing information for didanosine buffered formulation and pediatric powder for oral solution for dosage and administration of didanosine to pediatric patients. 

Even if a medication is available in multiple formulations and dosage forms, the prescriber must consider the absorption and distribution differences between adult and pediatric patients. Blood supply at injection or infusion site, available blood supply for unit muscle mass, and skeletal muscle mass relative to body mass vary with patient age and size, causing drug absorption to vary, as well. A rapid intravenous bolus in a pediatric patient might result in acute toxicity a slow intravenous infusion, often required in neonates, can cause erratic, unreliable drug delivery in an older child. In addition, the volume of fluid tolerated for intravenous delivery varies significantly with the age and size of the patient. The blood supply and blood flow to and from the injection site are of prime importance since a gradual decrease in blood supply per unit muscle mass is seen with maturation. In addition, the skeletal muscle mass relative to... 

Use of protease inhibitors other than LPV/r and NFV is problematic in children due to lack of suitable pediatric drug formulations for IDV and SQV (Table 10(a) and (b)). 

Kayumba, P. C., Huyghebaert, N., Cordelia, C., Ntawukuliryayo, J. D., Vervaet, C., and Remon, J. P. (2007). Quinine sulphate pellets for flexible pediatric drug dosing Formulation development and evaluation of taste-masking efficiency using the electronic tongue. Eur. J. Pharm. Biophurm. 66,460-465. 

Recommended dosage and monitoring requirements According to Micromedex, the effective doses of Lupron in prostate cancer are 1 mg subcutaneously daily, or in the depot formulation 7.5 mg intramuscularly (IM) monthly, 11.25 mg every 3 months, or 30 mg every 4 months. Lupron Depot-3 month 22.5 mg is used in the treatment of advanced prostate cancer. In endometriosis, the effective dose is 3.75mg depot IM monthly or 11.25mg every 3 months for 6 months. In central precocious puberty, the recommended starting dose of Lupron Injection Pediatric is 50pg/kg... 

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