St. John Fisher College Fisher Digital Publications
Pharmacy Faculty/Staff Publications Wegmans School of Pharmacy
11-2018
Basics of Compounding: Vehicles for Compounded Oral Liquid Medications: A Review
Kara Cutaia St. John Fisher College, [email protected]
Lipika Chablani St. John Fisher College, [email protected]
Fang Zhao St. John Fisher College, [email protected]
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Publication Information Cutaia, Kara; Chablani, Lipika; and Zhao, Fang (2018). "Basics of Compounding: Vehicles for Compounded Oral Liquid Medications: A Review." International Journal of Pharmaceutical Compounding 22.6, 480-489. Please note that the Publication Information provides general citation information and may not be appropriate for your discipline. To receive help in creating a citation based on your discipline, please visit http://libguides.sjfc.edu/citations.
This document is posted at https://fisherpub.sjfc.edu/pharmacy_facpub/187 and is brought to you for free and open access by Fisher Digital Publications at St. John Fisher College. For more information, please contact [email protected]. Basics of Compounding: Vehicles for Compounded Oral Liquid Medications: A Review
Abstract Compounded oral liquid medications play an important role in addressing the unmet needs of special patient populations, including pediatric, geriatric, and tube fed patients. The use of manufactured vehicles can streamline the compounding activities for pharmacists. In recent years, there is an increase in the availability of manufactured vehicles with various promotional features. This article uses the general formulation principles as a guide to compare and contrast the manufactured vehicles regarding their physicochemical properties, presence of preservatives and dyes, organoleptic properties, and ease of use. A summary table is provided as a reference tool to assist pharmacists in selecting the optimal vehicles for their patient care.
Disciplines Pharmacy and Pharmaceutical Sciences
Comments This article was published in the International Journal of Pharmaceutical Compounding Nov/Dec 2018 - Volume 22, Number 6, Pages 480-489: https://www.ijpc.com/Abstracts/Abstract.cfm?ABS=4536
Reprinted with permission.
This article is available at Fisher Digital Publications: https://fisherpub.sjfc.edu/pharmacy_facpub/187 BASICS OF COMPOUNDING Kara Cutaia, PharmD, LPN Vehicles for Compounded Oral Lipika Chablani, PhD Fang Zhao, PhD Liquid Medications: A Review
The authors’ affiliations Abstract are: Kara Cutaia, Resident Pharmacist, Unity Hospital, Compounded oral liquid medications play an important role In addressing the unmet needs Rochester Regional Health, of special patient popuiations, including pediatric, geriatric, and tube-fed patients. The use Rochester, New York; Lipika of manufactured vehicles can streamline the compounding activities for pharmacists. In Chablani, Associate Professor, recent years, there is an increase in the availability of manufactured vehicies with various and Fang Zhao, Professor, promotionai features. This articie uses the general formulation principies as a guide to Department of Pharmaceutical compare and contrast the manufactured vehicles regarding their physicochemical properties, Sciences, St. John Fisher Col lege Wegmans School of Phar presence of preservatives and dyes, organoleptic properties, and ease of use. A summary macy, Rochester, New York. tabie is provided as a reference tool to assist pharmacists in selecting the optimal vehicles for their patient care.
International Journal of Pharmaceutical Compounding unvw.lJPC.com 480 22 No. 6 I November December 2018 Unmedicated oral vehicles are used tent dosing, and maintain physical integrity Like suspensions, emulsions are dis to prepare oral liquid medications. throughout their shelf life.^ Physiochemical persed systems. Specifically, emulsions Compounding of oral liquid formulations properties to consider when preparing oral are dispersions of small globules of a sub expands treatment options for patients who liquid formulations include viscosity, sus stance in a vehicle in which it is immiscible. have difficulty swallowing tablets or cap pending agent, pH, and osmolality. Because emulsions contain at least two sules, as extemporaneous preparation can phases, often an aqueous and an oleaginous provide dosage forms that are not commer VISCOSITY AND SUSPENDING phase, they provide a liquid dosage form more suitable for drugs that are unstable cially available. Specific populations who AGENT may benefit from the compounding of these in aqueous formulations. Physical stability Oral liquid dosage forms include solu dosage forms include pediatric patients, challenges for emulsions include cream geriatric patients, and patients with enteral tions, suspensions, and emulsions. In solu ing (weak associations between droplets of feeding tubes. Multiple oral vehicles are tions, ingredients are solubilized in the the internal phase) and cracking (irrevers available, and these products differ in their solvent. Types of oral solutions include syr ible coalescence of droplets of the internal physicochemical and organoleptic proper ups, elixirs, spirits, and tinctures. Multiple phase). Viscosity regulators and thickening ties. These vehicles can be used to prepare syrups are commercially available as oral agents may be added to emulsions to slow a variety of oral liquid dosage forms includ liquid vehicles. These do not contain sus the rate of particle settling and improve the ing solutions, suspensions, and emulsions. pending agents, and viscosity is essential stability of the dispersion.® An example of This article provides a review of commer primarily for pharmaceutical elegance and an oral liquid vehicle available as an emul cially available oral vehicles as well as a ease ofuse.^ sification system is Fagron's Unispend discussion of vehicle properties to consider Suspensions are dispersed systems Anhydrous. This vehicle, available both when selecting a vehicle for a specific drug, which have physical-stability challenges. sweetened and unsweetened, is formulated route, and patient. This information may An ideal suspension settles slowly and with triglycerides and provides an anhy serve as a reference for compounding phar readily re-disperses upon agitation.® drous system which is favorable for water macists as well as for persons involved in During storage, suspensions may undergo unstable additives.^ formulating oral-liquid dosage forms for sedimentation and aggregation (including As evident from Table 1, common sus commercial applications. cake formation) leading to physical insta pending agents/viscosity enhancers include bility and variability in dosing. Inconsistent sodium carboxymethylcellulose, xanthan dosing can have severe consequences gum, and carrageenan. Each of these agents Discussion for patients including drug toxicity and, poses their own incompatibility issues that We have reviewed 26 oral liquid conversely, undertreatment. Increased a compounding pharmacist must consider vehicles, considering various aspects viscosity of suspensions can slow the rate while using the commercial oral vehicles such as: of particle setting. However, if viscosity that contain them. A detailed description is too high, the particles may be less read of incompatibility concerns for each of • Appearance ily re-dispersed upon agitation, and the these agents is available in the Handbook • Osmolality product may be difficult to pour and mea of Pharmaceutical Excipients f This study • pH sure.^'® Suspensions are formulated with provides a brief overview of some of these • Presence of preservatives and dyes suspending agents that maintain the physi major incompatibilities with respect to • Viscosity cal stability of the dispersion throughout each of these agents. Sodium carboxymeth • Suspending agent used the shelf life. Most of these suspending ylcellulose solutions are most stable at pH 5 • Taste agents are pseudoplastic or shear-thinning to 10, however, those solutions can tolerate systems, which leads to lowering of viscos a broader range of pH 2 to 10 for final prepa This information is summarized in Table ity with respect to increased shear stress rations. These solutions are also incompat 1 as a reference tool for compounding phar (i.e., shaking of the bottle or trituration of ible with quaternary nitrogen-containing macists. Additionally, we have examined the ingredients to compound the suspen compounds, iron salts, and metals such as published literature and reference books to sion). Along with the pseudoplastic rheol aluminum, mercury, and zinc. Similarly, provide context for this data. ogy, these systems are also thixotropic, a due to the anionic chemical structure of property which allows the system to regain xanthan gum, it is incompatible with large Physicochemical its viscosity once the shear stress has been cationic drugs, surfactants, polymers, and removed from the system. The thixotropic preservatives. Xanthan gum is also incom Properties behavior of such commercial oral vehicles patible with oxidizing agents, some tablet Oral dosage forms should be palatable and enhances the stability and shelf life of the film-coatings, dried aluminum hydroxide well tolerated, provide accurate and consis- compounded oral dispersions. gel, and some active ingredients such as
www.IJPC.com International Journal of Pharmaceutical Compounding Vol. 22 No. 6 I November December 2018 A Basics 1 amitriptyline, tamoxifen, and verapamil. OSMOLALITY Plus from Perrigo and Oral Suspend from Lastly, carrageenan-containing solutions Oral vehicles with high osmolality have Medisca at 157 mOsm/kg and 48 mOsm/kg, remain stable at pH 9 and can lead to its the potential to cause gastrointestinal respectively. Finally, one notable product depolymerization if the pH of the solution (GI) upset and diarrhea.®*^® Some special worth highlighting is SyrSpend SF from is rendered acidic. Also, carrageenan may patient populations are particularly prone Fagron. It is the only all-in-one vehicle interact with cationic active pharmaceuti to osmotic diarrhea. They include pediatric (sweetened, flavored, structured) with a low cal ingredients and is generally limited in patients, geriatric patients, and patients osmolality of <50 mOsm/kg. In addition, its use in such cases. with GI comorbidities such as irritable there are two similar SyrSpend SF powder A recent study by Visser et al® compares bowel syndrome. For instance, hyper products which are preservative-free but the rheological and sedimentation behavior tonic solutions of >400 mOsm/kg were require reconstitution before use. of some of the commercially available oral reported to injure GI tracts of neonates.® The concern of GI distress is heightened vehicles. The study describes the prepara Unfortunately, the osmolality data are not when the oral liquids are administered via tion of an oral suspension of paracetamol available for all vehicles from the manu enteral feeding tubes.® ’® Depending on the to evaluate the efficacy of the following facturers, and estimation is difficult for tubing types, the liquid medications are delivered directly to various GI regions oral vehicles: vehicles with proprietary formulas. The fol lowing discussion is based on the vehicles without dilution. As expected, the adverse • Base for Suspension with reported values (Table 1) and general effects are most pronounced when the • Ora-Blend scientific knowledge of oral liquid formula liquids are administered too rapidly into • Ora-Blend SF tions and excipients.’^^ the stomach or delivered directly to the • Simple Syrup The osmolality of the normal GI fluids is intestine. Since palatability is not a require ment for medications administered via • Suspendit between 100 mOsm/kg to 400 mOsm/kg.’® enteral feeding tube, it is recommended to • Syr-Spend SF PFI4 Several sugar-based syrup vehicles contain choose non-sweetened, non-flavored, and high concentrations of sucrose which result low-osmolality vehicles. If the viscosity of The study concludes that SyrSpend SF in extremely high osmolality. For example, these vehicles presents a challenge for some PH4 and Suspendit resulted in the best- the osmolality is 4109 mOsm/kg for Ora- narrow tubes, they should be diluted with compounded preparations due to their Sweet (Perrigo) and 2381 mOsm/kg for Oral purified water rather than another vehicle pronounced pseudoplastic rheological Syrup (Medisca). The same issue exists with high osmolality. profile. Both the vehicles provided adequate for some sugar-free vehicles, depending on sedimentation rates, even pourability, and the sweeteners used. Generally, the natural good resuspendability. These results are polyol sweeteners (e.g., sorbitol) have much Preservatives and Dyes 1 promising. However, the study can further 1 lower sweetness than the artificial sweeten Preservatives are often included in the i be expanded to include other commercially ers (e.g., sucralose) si®!"* and thus require formulations of oral liquid vehicles to pro available vehicles. much higher concentrations in the formula vide microbial stability. Aqueous formula i I tion. For example, sorbitol is used in a num tions are prone to microbial growth, and pH ber of commercial vehicles, and it is only preservatives protect against bacterial, Because many drugs are weak electro about 50% to 70% as sweet as sucrose.^® yeast, and mold infection. In addition to lytes (weak acids or weak bases), the pH Hence, a vehicle sweetened mainly by sor protecting the end user from pathogens, ■i of the formulation affects drug ionization, bitol still requires a high concentration of preservatives also provide a multiple year 1 ;! solubility, and physicochemical stability. sorbitol, which again leads to hyperosmolal shelf life for products. Parabens are the 1 Vehicles and formulations may be prepared ity. Furthermore, sorbitol is only partially most commonly-used class of preservatives with buffers to prevent sudden changes in absorbed in the GI tract. The non-absorbed which offer protection against a wide range pH.’' When selecting a vehicle for the oral sorbitol is fermented by the colonic flora of pathogens, even at low concentrations. liquid formulation, consideration should be with gaseous byproducts, which exacerbate Both methylparabens and propylparabens given to any data regarding the effect of pH the GI disturbances.’® As a safe practice, have low aqueous solubilities (1 g/400 mL on the solubility and stability of the drug the compounding pharmacist should make of water and 1 g/ 2,500 mL of water, respec being prepared in the formulation. Most sure that the sorbitol consumption from tively) and are often solubilized with the of the oral liquid vehicles described in this the prescribed dosage is below 20 g/day aid of small amounts of a co-solvent such as review have an acidic pH. For drugs that are for adults.® ’® On the other hand, the non- alcohol or propylene glycol. Methylparaben unstable in acidic pH, cdkaline vehicles are sweetened suspension vehicles tend to have is often used as a preferred preservative, available. An example of such a product is low osmolality, which are suitable choices as it can effectively preserve oral vehicles Fagron's SyrSpend SF Alka, which has a pH for patients who cannot tolerate hypertonic for a broader pH range of 4 to 8. Often, of >7. liquids. Two good vehicle examples are Ora- methylparaben is paired with propylpara- ,
. International Journal of Pharmaceutical Compounding www.lJPC.com ii 484 22 No. 6 1 November i December j 2018 TIBIE 1. SUMMARY OF VEHICLES FOR COMPOUNDED ORAL LIQUID MEDICATIONS. o < CQ CO w g O < ■J H & w H H CA CL H < A. Q, < ei a A I
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Many prestigious health organiza A, U a; >. >. the commercial oral vehicles, including syrups, H ■a satisfy this qualification and are effectively Eh o o (» > > preserved with this water-soluble preserva < fO u LD uo population are generally prepared in limited X O O liJ ..fe nitti M05 5 quantities, stored in refrigerators, and consumed > p 3 o O 5 W '■' Q g CNI immediately or within short durations from o 5 « o O s O (N g & o BJ & “ ffi preparation to avoid the use of preservatives. oc>- g H Z P. Z < z X X 3 H Cl Q- Organoleptic Properties iA CO o 73 tN Organoleptic properties pertinent to oral E 'L S liquid vehicles include taste, sweetness, and H > appearance. Patient adherence to therapy may www.IJPC.com International Journal of Pharmaceutical Compounding VoL 22 No. 6 I November December 2018 be enhanced when the dosage Practitioners should consider Practitioners should consider the effect form is palatable and pharma the effect of sweeteners, poten ceutically elegant. Some oral tially avoiding those that cause of sweeteners, potentially avoiding those vehicles are flavored, while oth diarrhea in certain patients, ers are unflavored, allowing the while recognizing that laxa that cause diarrhea in certain patients, compounding pharmacist to tive effects may actually be add flavors that match patient beneficial for patients who while recognizing that laxative effects preference. Syrups have a high are chronically constipated. degree of sweetness, which The physical appearance of may actually be beneficial for patients may be appealing to particu commercially available oral lar patient populations such vehicles varies, ranging from who are chronically constipated. as pediatric patients. Some clear to hazy and colorless to vehicles contain sugar-free tinted (tjT)ically pink or red sweeteners (including sugar if colored). Multiple com alcohols) with the advantage mercially available oral vehicles are also capable of should be maintained within a range high of the lower glycemic load for taste-masking, which further enhances the palatability enough to maintain physical stability but diabetic patients. As discussed of compounded formulations, particularly when addi low enough to permit these procedures. To previously under the topic of tives have an unpleasant taste. further facilitate ease of use, the product osmolality, sugar alcohols such In patients who are receiving medications through should re-disperse readily upon simple as sorbitol can cause osmotic an enteral feeding tube, organoleptic properties are agitation.® Prolonged or vigorous agitation diarrhea, as can sugars.® less important as the patient wiU not experience taste may be time consuming or complicated for and sweetness providers and patients alike. Additionally, due to the route patients, pharmacists, and caregivers may of drug delivery. have different interpretations of the direc However, physico tions “Shake well before using.”® Dosage RS SOFTWARE chemical proper forms prepared with oral liquid vehicles POWERFUL USER FRIENOLY ties remain crucial should be able to provide uniform contents SOFTWARE THAT WORKS FOR YOU as feeding tubes after simple manual agitation. present unique Additionally, most of these oral vehicles Realizing that niche pharmacy is tt drug-delivery are avculable in conveniently packaged key to success in this industry. We challenges. When one-pint contciiners (473 mL), with a continually added tools intended to administration 24- to 36-month shelf life. This allows help pharmacists perform their through an enteral the pharmacist to easily stock and store niche functions as efficiently tube is intended, these buffered, sweetened, flavored, and as possible, thus creating the the dosage form preserved oral vehicles in their inventory. ultimate pharmacy solution. must neither be too Further, current published literature pro viscous nor contain vides a plethora of information regarding sizeable particulate the formulation and stability of several matter which could active pharmaceutical ingredients in these occlude the tube. commercial vehicles. This strengthens the database for utilizing these vehicles to Ease of Use provide improved patient care. Due to the OUR SYSTEMS THAT WORK FOR YOU For ease of use, stability and versatile applications of these • Script Assist oral vehicles ide vehicles for compounded oral-liquid dos • Compound Assist ally permit pour age forms, several pharmacies have phased • Prescription Assist ing, measuring, out from preparing their in-house United • HIPAABank withdrawal into an States Pharmacopeia-compliant oral vehi oral syringe, and cles. The resulting increase in demand and instillation through competition by several manufacturers for an enteral feed these vehicles thereby feeds the cost-to- Norman, OK | (405)321-5356 | [email protected] ing tube. Viscosity benefit ratio of purchasing these vehicles. International Journal of Pharmaceutical Compounding www.IJPC.com 488 yqi 22 No. 6 j November ; December | 2018 Basics Cost Comparison 12. Dickerson RN, Melnik G. Osmolality of oral Conclusion drug solutions and suspensions. Am J Hosp Standardized, current pricing informa In conclusion, multiple un-medicated oral Syst Pharm 1988; 45(4): 832-834. tion was not readily available for all the vehicles are available for use in preparing oral 13. Grembecka M. Sugar alcohols—their role in products. However, the average wholesale the modern world of sweeteners: A review. formulations. By comparing physicochemical price (AWP) reported in Red Book ranged Eur Food Res Technol 2015; 241(1): 1-14. and organoleptic properties, the compound from approximately $16 to $63 (USD) per 14. Thompson J. A Practical Guide to ing pharmacist can select the oral vehicle best 473 mL.^® The actual cost of obtaining the Contemporary Pharmacy Practice. 3rd ed. suited for the drug, route, and patient. Lippincott Williams & Wilkins; 2009, vehicles can vary significantly from the 15. Williams NT. Medication administration AWP, depending on multiple factors such through enteral feeding tubes. Am J Health as bulk purchasing discounts and contract References Syst Pharm 2008; 65(24): 2347-2357. pricing between the manufacturer and 16. [No author listed.] Parabens: The 1. Mobley WC. Dispersed systems. In: Amiji MM, buyer. For some of these products, mul Importance and Safety of Preservatives. Cook TJ, Mobley WC, eds. Applied Physical tiple package sizes are available, which Medisca, Inc. Accessed January 16,2018. Pharmacy. 2nd ed. New York, NY: McGraw-Hill 17. Bruns C, Ober M. Development and could impact pricing. Education; 2013. Preparation of Oral Suspensions for 2. AUen LV Jr., Popovich NG, Ansel HC.. Ansel's Paediatric Patients - a Challenge for Pharmaceutical Dosage Forms and Drug Delivery Pharmacists. Pharm Technol Hosp Pharm Limitations Systems. 9th ed. Baltimore, MD: Lippincott 2018; 3(2): 113-119. Williams & Wilkins; 2011. This review is intended to describe com 18. Truven Health Analytics LLC. Red Booh. 3. Helin-Tanninen M, Autio K, Keski-Rahkonen mon oral vehicles that may be seen in prac 2018. Accessed February 22,2018 via P et al. Comparison of six different suspension tice, and, as such, there may be additional MicroMedex. vehicles in compounding of oral extemporaneous oral vehicles on the market which have not 19. Ora-Sweet; Ora-Sweet SF; Ora-Plus; Ora- nifedipine suspension for paediatric patients. Eur Blend; Ora-Blend SF. Perrigo Pharaceuticals. been included. While multiple flavors and J Hasp Pharm Sci Pract 2012; 19(5): 432-437. [Perrigo Website.] 2018. Available at: www. package sizes are available for some of the 4. Fagron. Documents (MSDS & CoA). [Fagron perrigo.com/. Accessed March 7,2018. products described in this review, these Website]. 2018. Available at: https://fagron.com/ 20. Oral Suspend; Oral Syrup; Oral Mix; Oral parameters were simplified for the sake en/knowledge/documents. Accessed March 13, Syrup SF; Oral Mix SF. Medisca. [Medisca 2018. of summarization. In the case of multiple Website.] 2018. Available at: www.medisca. 5. Sheskey PJ, Cook WG, Cable CG. Handbook available pack^e sizes, a representative com/products/compounding-bases/oral. of Pharmaceutical Excipients. Washington, package size is described in the Tables. The Accessed March 7,2018. DC: American Pharmacists Association representative package size was selected as 21. Flavor Blend; Flavor Sweet; Flavor Plus; (APhA); 2017. the closest size to 473 mL to facilitate com Flavor Sweet- SF; Versa Free; Versa Plus; 6. Visser JC, Seldam IE, van der Linden IJ et al. Sinmple Syrup; Cherry Syrup. Humco. parison between products. Comparison of rheological and sedimentation [Humco Website.] 2018. Available at: www. We identified four additional oral liquid behavior of commercially available suspending humco.com/store/pharmaceuticals/com- vehicles, manufactured by Professional vehicles for oral pharmaceutical preparations. pounding-bases/oral-vehicles/. Accessed Compounding Centers of America (PCCA), JJPC 2018; 22(3): 247-251. March 12,2018. 7. Sandmann B J, Dash AK, Al-Achi A et al. Ionic which were not included in Table 1. These 22. Professional Compounding Centers of equilibria and buffers. In: Amiji MM, Cook TJ, formulations are proprietary and, as such, America. Suspendit. PCCA 2016 Catalog. Mobley WC, eds. Applied Physical Pharmacy. 2nd we were not able to obtain data regarding [PCCA Website.] 2016. ed. New York, NY: McGraw-Hill Education; 2013. specific ingredients and physicochemical 23. SyrSpend SF; SyrSpend SF Powder; 8. Makinen KK. Gastrointestinal disturbances properties. These products are PCCA-Plus SyrSpend SF PH4 (Liquid); SyrSpend SF associated with the consumption of sugar PH4 (Dry for reconstitution); SyrSpend SF Oral Suspending Vehicle, Syrup Vehicle, alcohols with special consideration of Xylitol: Alka (Dry, for reconstitution); UniSpend Sweet-SF Sugar-free Syrup Vehicle, and Scientific review and instructions for dentists Anhydrous (Sweetened); UniSpend Acacia Syrup. The compounding pharma and other health-care professionals. Int J Dent Anhydrous (Unsweetened). Fagron. [Fagron cist may be able to obtain guidance regard 2016:2016:1-16. Website.] 2018. Available at: https:// 9. Dickerson RN. Medication administration con ing these products from the manufacturer. us.fagron.com/en-us/knowledge/product- siderations for patients receiving enteral tube An additional limitation is the fact that innovations. Accessed March 7,2018. product availability and formulations may feedings. Hosp Pharm 2005; 40(12): 1081-1085. 10. Edes TE, Walk BE, Austin JL. Diarrhea in Tube- change over time. This article does not fed patients: Feeding formula not necessarily the Address correspondence to Kara Cutaia, replace the responsibility of the compound cause. Am J Med 1990; 88(2): 91-93. PharmD, LPN, Resident Pharmacist, Unity ing pharmacist to check technical data 11. Elder DL. A Practical Guide to Contemporary Hospital, Rochester Regional Health, 1555 sheets and ingredient lists for the oral vehi Pharmacy Practice and Compounding. 4th ed. Long Pong Road, Rochester, NY14626. cles that they use to prepare dosage forms. Philadelphia, PA Welters Kluwer; 2018. Email: [email protected] ^ www.IJPC.com International Journal of Pharmaceutical Compounding Vol. 22 No. 6 I November j December j 2018