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38 BUSINESS THROUGH INNOVATION COMPOUNDING IPAEDIATRIC COMPOUNDING t’s fair to say that one of the most common requests for compounding is omeprazole suspension. But the preparation of omeprazole is not that easy and has changed a lot over the past 10 years or so. Omeprazole is a chemical that is not stable in stomach acid, which is why the commercial tablets have enteric coated pellets to protect it in the gut. Therefore, we must add a significant amount of sodium bicarbonate to the suspension, and can use certain flavours only – those compatible with the required alkalinity of a pH above 8-8.5. The APF 24 formula is written for omeprazole 2mg per ml. For a long time we had no stability data for longer than 30 days for any strengths higher than 4mg per ml. In recent times, many suppliers of raw materials have worked with their R&D departments to provide formulas for the higher strength requests (typically 5mg per ml) with much longer stability data. These formulas have been a real game changer for parents with children who suffer from reflux, but also for pharmacists who are able to provide preparations with longer validated beyond use by dates. If you’re a pharmacist who has been “making omeprazole for years”, now is the perfect time for you to review your formulations and check whether there are some better options. However, many pharmacists hit a stumbling block when they have a request for other paediatric medicines. I always recommend that compounders based near public hospitals or paediatricians should always keep a range of suspending vehicles and flavouring agents for those situations, which most typically occur on a Friday afternoon – a child is discharged from the hospital but has been given only one or two doses to keep them going. Almost 27 per cent of medicines that have a paediatric indication are unavailable in a paediatric dosage form.1 More than a dozen suspension formulas in the APF will get a compounder out of trouble if they’re unable to access their technical support team late at night or on a weekend. Most of the formulas also use the commercial tablets, but it’s extremely important to make sure all the extra notes attached to those formulas are read. Ignoring the notes may result in a preparation that doesn’t come together correctly, and is therefore unacceptable to be supplied to the patient. The formula for propranolol suspension 5mg per ml is written using the raw propranolol powder, which is the preferred method of preparation. However, a note states that the commercial tablets may be crushed and incorporated into this formula. The tablets used should not contain calcium carbonate, as this excipient is incompatible with the formula and the suspension will ‘clump’. This is one setting where using a generic tablet may be unsuitable. It’s always preferable to use the raw powder if it’s available. I’ve often mentioned in other articles that there may be other compounding opportunities to consider once you have the raw material. This is certainly the case with propranolol. In paediatric patients, oral propranolol is indicated for use in some very serious conditions, such as supraventricular and ventricular tachycardia or hypertrophic cardiomyopathy, so it’s understandable that supply to a patient must often meet a critical time frame. Another indication for the use of propranolol in paediatric patients is for the condition known as ‘infantile haemangioma’. Haemangiomas appear as a birthmark on the skin and usually red or purple in colour due to the cluster of extra blood vessels. They are sometimes referred to as ‘strawberry birthmarks’ or ‘strawberry naevus’. This is a non-cancerous condition and in many cases they will shrink on their own. However, they tend to grow quickly in a young child and this can be extremely distressing for the parents. Propranolol is thought to inhibit the growth of blood vessels and constrict existing blood vessels within the haemangioma. This treatment is generally well tolerated and usually continues over a six-month time frame. In recent years, the use of topical propranolol at strengths between 0.5% and 5% has been investigated. It may be less effective than oral, but suitable for patients with smaller, superficial haemangiomas, or where the oral preparation is not well tolerated. Paediatric compounding is an extremely rewarding area of practice. Compounders should not overlook the opportunity to liaise with their local paediatrician to discuss treatment options for their patients. Reference 1. Tan E, et al. ‘Dosing information for paediatric patients: Are they really “therapeutic orphans?’ MJA, 2003; 179: 195–198. By Marina Holt. Education and Training Manager PCCA Australia Marina Holt BPharm Dip Quality Auditing Cert IV TAE is the Education and Training Manager at PCCA Australia. Her main role is to give training on all aspects of compounding pharmacy to registered pharmacists and students, and to increase awareness of health professionals on the benefits compounded medications may have for their patients. Inquiries: marina@pccarx.com.au RETAIL PHARMACY • AUG 2020