COMPOUNDING SPECIAL DOSAGE FORMS M Ansari Pharm D

COMPOUNDING SPECIAL DOSAGE FORMS M. Ansari Pharm D, Ph. D Associate Professor of Pharmaceutics

Packaging, Storage and Distribution of Compounded Pharmaceuticals General "Good Compounding Practices" for Nonsterile Products Compounding Gels Compounding Capsules Troches and Lozenges Compounding Suppositories: Part II Compounding Suppositories: Part I Compounding Rectal Dosage Forms, Part 1 Compounding Rectal Dosage Forms - Part II 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 2

Emulsions Compounding Topical Dosage Forms: Ointments, Creams, Pastes and Lotions Ointment Compounding: Basic Concepts Topical Antibiotic Dosage Forms Compounding Oral Liquids Preparation of Oral Suspensions and Syrups: Basic Concepts 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 3

USP Chapter <795> Pharmaceutical Compounding - Nonsterile Preparations Compounding for Lacquers, Varnishes, Collodions and Protectants Compounding for Gastrointestinal Disorders Compounding for Otic Disorders Compounding for Sports Injuries 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 4

Compounding for Glycerin & Propylene Glycol Compounding for Scalp Disorder Compounding for Wound Care Compounding for Superficial Fungal Infections A History of Pharmaceutical Compounding for Phonophoresis Compounding for Acne Compounding for Iontophoresis 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 5

Compounding for Dermatology Patients Compounding for Dentists and Dental Patients Compounding for Patients with Psoriasis Compounding for Diabetic Patients Compounding For Hospice Patients Compounding For Geriatric And Arthritis Patients Compounding For The Management Of Pain 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 6

Need For Extemporaneous Formulations In Pediatric Patients Compounding For Male Andropause Compounding For Hormone Replacement Therapy Compounding, Stability and Beyond-Use Dates Veterinary Compounding Nasal Preparations Compounding Ophthalmic Liquids 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 7

Inhalation Products Compounding Medication Sticks Pharmaceutical Compounding Calculations Pharmaceutical Compounding Tips and Hints 9/6/2021 Pharm D, Ph. D, Associate Professor, KUMS, Kerman, Iran 8

Packaging, Storage and Distribution of Compounded Pharmaceuticals The outward appearance of the prescription drug package is often the only tangible basis for a patient’s judgement of a pharmacist’s care and skill. A package can be described as an economical means of providing protection, presentation, identification and convenience for a product until such time as it is completely used or consumed.

Packaging, Storage and Distribution of Compounded Pharmaceuticals Storage of pharmaceuticals is the pharmacist’s responsibility from the time of receipt of the product and continues to the counseling of the patient on the proper storage of the medication at home or in an institution during the time of administration.

Packaging, Storage and Distribution of Compounded Pharmaceuticals Products are best stored at a uniform temperature for optimal results. However, it may be the common practice of many pharmacists to alter thermostat setting when closing up for the night, such as increasing the temperature setting during the summer months and decreasing the temperature setting during the winter months, to help reduce utility costs. Wide temperature range variations should be discouraged as they may affect the stored drug products. Storage temperatures and Mean Kinetic Temperature will be discussed later in this issue.

PACKAGING Container Immediate container A primary container A secondary container Prior to being used, a container must be “clean”. the container must not interact physically or chemically with the preparation that is placed in it so as to alter the strength, quality or purity of the article beyond the official requirements

Storage A cold place is any temperature not exceeding 8ºC (46ºF). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2ºC (36ºF) and 8ºC (46ºF). A cool place is any temperature between 8ºC (46ºF) and 15ºC (59ºF). An item that is indicated for storage in a cool place may also be stored in the refrigerator.

General "Good Compounding Practices" for Nonsterile Products

GCP Facility Personnel Equipment Ingredient selection The componding process Packaging and storage Controls Labeling Stability, expiration PATIENT COUNSELING Reference Library

RECORDS AND REPORTS Formulation Record (Master Control Record) Compounding Record Equipment-Maintenance Records Ingredient Records

COMPOUNDING GELS Gels are semirigid systems in which the movement of the dispersing medium is restricted by an interlacing three-dimensional network of particles or solvated macromolecules of the dispersed phase. A high degree of physical or chemical cross-linking may be involved. The increased viscosity caused by the interlacing and consequential internal friction is responsible for the semisolid state.

Capsules The most versatile of all dosage forms is the capsule. The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most frequently utilized dosage forms in Western medicine.

TROCHES AND LOZENGES

Emulsions

Compounding ointment