Transcript Compounding special dosage forms

M. Ansari
Pharm D, PhD
Associate Professor of Pharmaceutics
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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
7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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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
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7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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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
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7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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Compounding for Glycerin & Propylene Glycol
Compounding for Scalp Disorder
Compounding for Wound Care
Compounding for Superficial Fungal Infections
A History of Pharmaceutical Compounding
Compounding for Phonophoresis
Compounding for Acne
Compounding for Iontophoresis
7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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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
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7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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Need For Extemporaneous Formulations In
Pediatric Patients
Compounding For Male Andropause
Compounding For Hormone Replacement
Therapy
Compounding, Stability and Beyond-Use Dates
Veterinary Compounding
Compounding Nasal Preparations
Compounding Ophthalmic Liquids
7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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Inhalation Products
 Compounding Medication Sticks
 Pharmaceutical Compounding Calculations
 Pharmaceutical Compounding Tips and
Hints
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7/17/2015
Pharm D, PhD, Associate Professor, KUMS,
Kerman, Iran
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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.
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Packaging, Storage and Distribution
of Compounded Pharmaceuticals
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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
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Products are best stored at a uniform temperature
for optimal results. However, it may be the common
practice of many pharmacists to alter the
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
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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.
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General "Good Compounding
Practices" for Nonsterile Products
GCP
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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
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COMPOUNDING GELS
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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
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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