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PP-041 Extemporaneous preparation of oral liquid formulation of capecitabina
  1. R Morón Romero,
  2. M Valle Corpas,
  3. MDC González Medina,
  4. C Gómez Peña,
  5. A Caballero Romero,
  6. A Valle Ruiz de la Guardia,
  7. A Rodriguez Delgado,
  8. J Cabeza Barrera
  1. Complejo Hospitalario Granada. Hospital San Cecilio, Hospital Pharmacy, Granada, Spain

Abstract

Background Oncology patients often have swallowing problems or dysphagia. Dysphagia is a frequent syndrome in patients with tumours involving the CNS, head and neck, and upper aerodigestive tract. This can be the initial symptom or related to the oncological treatment.

These patients may have difficulty orally ingesting solid forms of drugs and therefore semi-solid formulations are needed. In dysphagia, galenic formulations should be modified. Oncology pharmacists face a constant challenge with patients who cannot swallow oral drugs, by making extemporaneous oral liquid preparations a requirement for their treatment.

Purpose To describe extemporaneous preparation of capecitabina oral liquid formulation.

Material and methods We performed a PubMed literature search (1966 to May 2014) for all studies published in the English language using the generic name of the identified drugs and the following search terms: extemporaneous formulations, oral liquid or suspension, compounding, anticancer therapy, antineoplastic agent, stability pharmacokinetics and biovailability.

Drug: capecitabine.

Dosage forms: tablet (film coated):150 and 500 mg.

Procedure 500 mg/5 mL oral suspension can be prepared by crushing 37 capecitabine tablets (500 mg) in a mortar, mixing the powder with approximately 92.5 mL of oral plus (contains carboxymethulcellulose sodium and xanthan gum as thickeners) and 92.5 mL oral sweet (contains sucrose and sorbitol as excipients) (5 mL/ 500 mg) and stirring it for about 15 min until the tablets are dissolved.

Storage and stability: the United States Pharmacopoeia (USP) also provides general guidelines on stability and beyond use dates for extemporaneously compounded prescriptions. For microbiology reasons, unless published data support a longer expiration time, the beyond use date for any water (oral sweet and oral plus containing formulations prepared from ingredients in solid form) is limited to 2 weeks, and the liquid must be stored in a refrigerator.

Results The development of a national guideline to promote standards of practice in these non-traditional settings may help us to improve the safety of dispensing and handling oral chemotherapy, including extemporaneously compounded oral liquid formulations of hazardous drugs.

Conclusion The extemporaneous compounding preparation of an oral formulation fills a gap in therapy when there are no commercial therapeutic alternatives.

No conflict of interest.

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