Sagar Shah

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that causes airflow obstruction in the lungs.

COPD is the third-leading cause of death in the United States, and about 15.7 million Americans have been diagnosed with the disease. Tobacco smoke is a major factor in the development and progression of COPD. Other causes include exposure to air pollutants at home or in the workplace, genetic factors, and respiratory infections. Long-term exposure to cigars, gases from fires, marijuana, and pipes can lead to bronchitis or emphysema. Bronchitis is the narrowing of the bronchial tubes, resulting in mucus production, and emphysema is the destruction of small passages within the lungs called alveoli.

 Individuals with alpha-1 antitrypsin (AAT) deficiency are at a higher risk of developing COPD, because AAT helps protect the lungs from damage resulting from inflammation.

Spirometry is required to assess the lung function and to make a COPD diagnosis. Spirometry measures the total amount of air an individual can breathe out, also called force vital capacity (FVC). It measures force expiratory volume (FEV1), which is the amount of air exhaled in 1 second. The post-bronchodilator FEV1 is assessed using spirometry, which helps determine the severity of the disease.

Symptoms of COPD include and excess phlegm, mucus, or sputum production; frequent coughing or wheezing; and shortness of breath. Treatment helps decrease the symptoms and prevents further complications, such as exacerbation and hospitalization.

Patients’ airflow limitation with a post-bronchodilator forced expiratory volume/forced vital capacity (FEV1/FVC) <0.7, is classified based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as either GOLD 1 (mild), GOLD 2 (moderate), GOLD 3 (severe), or GOLD 4 (very severe).

 Patients’ symptoms burden and risk of exacerbation are classified into GOLD groups A through D, and this is used to guide patients therapy. Classification of airflow limitation (grades 1 through 4) and symptom burden with exacerbation risk (groups A through D) is patient-specific and can occur in a variety of combinations.

Bronchodilators are the first-line therapy for all patients. With COPD disease progression, combination therapy is often required to control the symptoms, which include 2 bronchodilators, such as a long-acting beta-2 agonist (LABA), plus a long-acting muscarinic antagonist (LAMA). This therapy can be combined with an inhaled corticosteroid (ICS), as well, depending on the severity of the disease.

 Inhaled corticosteroids inhibit the inflammatory response. Long-acting beta-2 agonists bind to beta-2 receptors, causing relaxation of bronchial smooth muscles, which leads to bronchodilation. Long-acting muscarinic antagonists cause bronchodilation by blocking the constricting action of acetylcholine at M3 muscarinic receptors in the bronchial smooth muscle. Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) and Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, are the new triple combination therapy options that are FDA-approved for patients with COPD.

Trelegy Ellipta is a combination of 3 active ingredients. They are fluticasone furoate, an inhaled corticosteroid; umeclidinium, an anticholinergic; and vilanterol, a long-acting beta-2-adrenergic agonist (LABA). The FDA approved Trelegy in September 2017, and it is manufactured by GlaxoSmithKline pharmaceutical. Trelegy is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD. It is also indicated to reduce exacerbations of patients with COPD who have a history of exacerbations. The most common adverse reactions are back pain, bronchitis, headache, oral candidiasis, pneumonia, and upper-respiratory-tract infection.

Breztri Aerosphere is a combination of budesonide, an inhaled corticosteroid; formoterol fumarate, a LABA; and glycopyrrolate, an anticholinergic agent. The FDA approved Breztri in July 2020, and it is manufactured by AstraZeneca. Breztri is indicated for the maintenance treatment of patients with COPD. The most common adverse reactions are back pain, oral candidiasis, pneumonia, and upper-respiratory-tract infection.

With COPD, the limitation of airflow is not fully reversible, which leads to a gradual loss of lung function. Early detection may change the course and progression of the disease. There are variety of inhalers in the market for the treatment of COPD. First-line therapies are dependent upon a patient’s GOLD classification, as well as other factors, such as cost and type of inhaler.

 The hope is for the patients who receive a COPD diagnosis to be treated with the correct inhalation regimens, then with combination therapies, such as those mentioned above, decreasing the frequency of emergency department visits and have hospitalizations.

, is vice president of pharmacy operations at Mini Pharmacy in Los Angeles, California.

 is a PharmD candidate at West Coast University's School of Pharmacy in Los Angeles.

CDC. Basics about COPD. Updated July 19, 2019. Accessed July 27, 2020. 

https://www.cdc.gov/copd/basics-about.html

GOLD. Global Initiative for Chronic Obstructive Lung Disease. Accessed July 27, 2020. https://goldcopd.org/

Roth OZ, Crocetta NP, Ostroff ML. A review of the 2019 GOLD guidelines for COPD. 

https://www.uspharmacist.com/article/a-review-of-the-2019-gold-guidelines-for-copd

Breztri Aerosphere [prescribing information). Wilmington, DE: AstraZeneca; 2020. Accessed November 10, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212122s000lbl.pdf

Trelegy Ellipta [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf

Articles

Pharmacists should familiarize themselves with these therapies to help patients lessen the risk of emergency department visits and hospitalizations.
 

Consider New Treatment Options for COPD

About 40% of American adults cannot or will not swallow solid forms of medications.

There are many different types of oral formulations or solid dosage forms, such as capsules and tablets, which are preferred, because of the cost-effectiveness, dosing convenience, and high physicochemical stability.

 However, certain solid formulations can be difficult for elderly patients and infants with dysphasia. This difficulty encouraged development of a new medication with liquid and sprinkle formulations.

Sprinkle formulations are drugs that contain granules or pallets that can be mixed with soft food prior to administration. These formulations provide the same dosing flexibility and ease of ingestion as liquid formulations. Sprinkle formulations can be sprinkled on applesauce or yogurt, which can mask the unpleasant smell and taste of a drug. Sprinkle formulations have a higher stability of drugs compared with liquid formulations during storage. Numerous drugs that have been previously available as tablet formulations have now been approved as sprinkles, including Drizalma (duloxtine), Ezallor (rosuvastatin), and Kapspargo (metoprolol succinate). Other drugs approved as a liquid formulation are Carospir (spironolactone) and Riomet ER (metformin hydrochloride for extended-release oral suspension).

Carospir (spironolactone) oral suspension is an aldosterone approved by the FDA on August 7, 2017 and is manufactured by CMP Pharmaceutical Industries. Carospir is indicated for the treatment of NYHA Class III-IV heart failure and reduced election fraction to increase survival, manage edema and to reduce hospitalization for heart failure. It is also used as an add-on therapy for the treatment of hypertension and management of edema in adult patients with cirrhosis. Carospir is a stable, ready to use, and consistent liquid treatment option for adult patients who have difficulty swallowing, or who cannot swallow tablets.

Drizalma Sprinkle (duloxetine delayed-release capsules) is a serotonin and norepinephrine reuptake inhibitor (SNRI) that the FDA approved on July 19, 2019, and it is manufactured by Sun Pharmaceutical Industries. Drizalma is indicated for chronic musculoskeletal pain in adults, diabetic peripheral neuropathic pain in adults, generalized anxiety disorder in adults and pediatric patients ages 7 to 17 years, and major depressive disorder in adults. It is available in 20-, 30-, 40-, and 60 mg. Drizalma provides a controlled and predictable release, and the ability to be administered via a nasogastric tube, and it can be sprinkled over applesauce.

Ezallor Sprinkle (rosuvastatin capsules) is a HMG-Co-A reductase inhibitor indicated for adult patients with hypertriglyceridemia, primary dysbetalipoproteinemia (Type III hyperlipoproteinemia), and homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB. Ezallor was FDA-approved on December 18, 2018 and is manufactured by Sun Pharmaceutical Industries. It is available in 5 mg, 10 mg, 20 mg, and 40 mg. Ezallor can be administered as a single dose at any time of day, with or without food. For patients who are unable to swallow capsules, the capsules can be opened for administration.

Kaspargo Sprinkle (metoprolol succinate capsules) is a β

-selective adrenoceptor blocking agent approved by the FDA on January 26, 2018 and is manufactured by Sun Pharmaceutical Industries. Kaspargo is indicated for hypertension (to lower blood pressure), angina pectoris, and heart failure (to reduce the risk of cardiovascular mortality and hospitalization). It is administered once daily and is available in 25mg, 50mg, 100mg, and 200mg. The benefit of Kaspargo is that it provides a controlled and predictable release, can be sprinkled over applesauce, and the ability to be administered via a nasogastric tube.

Riomet ER (metformin hydrochloride for extended-release oral suspension) is a biguanide that the FDA approved on August 29, 2019, that is manufactured by Sun Pharmaceutical Industries. Riomet ER is indicated to improve glycemic control in adults and pediatric patients age 10 years and older with type 2 diabetes mellitus. Riomet ER is available in 16-oz. bottles and comes in grape and strawberry flavors. The extended-release liquid formulation allows for once-daily dosing without the need to break, chew, or crush a tablet. The starting dose is 500 mg (5 mL) orally once daily with the evening meal; the dose can be increased in increments of 500 mg (5 mL) weekly, up to a maximum dose of 2000 mg (20 mL), once daily with the evening meal.

Oral delivery is a desirable route of administration for many patients. These new formulations of drugs are intended to help patients who are in long-term-care facilities and residents who cannot or will not swallow solid medication form. Liquid and sprinkle formulations can help improve adherence to medications.

, is the vice president of pharmacy operations at BioScrip Infusion in Burbank, California.

 is a PharmD candidate at West Coast University School of Pharmacy in Los Angeles, California.

Center for Drug Evaluation & Research. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry. FDA.

Tahaineh L, Wazaify M. Difficulties in swallowing oral medications in Jordan. 

 2017;39(2):373-379. doi: 10.1007/s11096-017-0449-z

Logrippo S, Ricci G, Sestili M, et al. (2017, January 31). Oral drug therapy in elderly with dysphagia: between a rock and a hard place! 

 2017;12:241-251. doi: 10.2147/CIA.S121905

Carospir oral suspension [prescribing information]. Farmville, NC; CMP Pharma, Inc: 2017. Accessed August 11, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209478s000lbl.pdf

Drizalma Sprinkle [prescribing information]. Cranbury, NJ; Sun Pharmaceutical Industries, Ltd: 2019. Accessed August 11, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212516s000lbl.pdf

Ezallor Sprinkle [prescribing information]. Gujarat, India; Sun Pharmaceutical Industries, Ltd: 2020. Accessed August 11, 2020. 

https://www.healthgrades.com/drugs/ezallor-sprinkle

Kapspargo Sprinkle [prescribing information]. Cranbury, NJ; Sun Pharmaceutical Industries, Ltd: 2018. Accessed August 11, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf

Riomet Sprinkle [prescribing information]. Cranbury, NJ; Sun Pharmaceutical Industries, Ltd: 2019. Accessed August 11, 2020. 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212595s000lbl.pdf

Elderly patients and infants with dysphasia who cannot or will not swallow solid medications can take liquid or sprinkle ones.
 