PHARMACEUTICAL

PRAKTICE I
BY :
1. PUJI RAHMI SUMARNO (1411011051)
2. KATRIN DAYATRI (1411011052)
3. DYRA EKA AULIA KHAIDIR (1411011055)
4. GHINA FADHILAH (1411011068)
5. RIZKI KURNIA AFRIYANTI (1411012015)
COMPOUNDING
EQUIPMENT
Compounding
Compounding is defined as the preparation, mixing, assembling, altering, packaging,
and labeling of a drug, drug-delivery device, or device in accordance with a licensed
practitioners prescription, medication order, or initiative based on the practitioner
patientpharmacistcompounder relationship in the course of professional practice.
Compounding includes the following:
Preparation of drug dosage forms for both human and animal patients
Preparation of drugs or devices in anticipation of prescription drug orders, on the basis of
routine, regularly observed prescribing patterns
Reconstitution or manipulation of commercial products that may require the addition of one
or more ingredients
Preparation of drugs or devices for the purposes of, or as an incident to, research (clinical or
academic), teaching, or chemical analysis, and
Preparation of drugs and devices for prescribers office use where permitted by federal and
state law
 Extemporaneous compounding is defined as the timely preparation of a drug
product according to a physicians prescription, a drug formula, or a recipe in which
calculated amounts of ingredients are made into a homogenous (uniform) mixture
Compounding Equipment
The equipment and utensils used for compounding of a drug preparation shall be of
appropriate design and capacity. The equipment shall be of suitable composition
that the surfaces that contact components are neither reactive additive, nor
sorptive and therefore will not affect or alter the purity of the compounded
preparations. The types and sizes of equipment depend on the dosage forms and
the quantities compounded
Equipment shall be stored to protect it from contamination and shall be located to
facilitate its use, maintenance and cleaning. Automated, mechanical, electronic,
and other types of equipment used in compounding or testing of compounded
preparations shall be routinely inspected, calibrated as necessary, and checked to
ensure proper performance. Immediately before compounding operations, the
equipment shall be inspected by the compounder to determine its suitability for
use. After use, the equipment be appropriately cleaned.
Compounding Equipment
a. Balances
1) Class A Prescription Balance
The Class A Prescription Balance is a two-pan torsion type balance that utilizes both
internal and external weights. The Class A Prescription Balance is used in the Pharmacy
setting as a means of determining the weight of a material to be used in the compounding
of a prescription or manufacturing of a dosage form. The minimum weight that can be
weighed on this balance is 120 milligrams (mg) and the maximum weight is 120 grams
(gms).
Proper care of the Class A Prescription Balance is important to ensure accurate
measurements. Always keep the balance in the locked position, except when equilibrium is
being tested and never add or remove weight or materials unless the balance is in the
locked position. The balance should be kept clean at all times, and care should be taken to
avoid vibration, dust, moisture and corrosive vapors. The balance cover should be kept
down at all times except when the balance is in use.
 Analytical Balance
With the advent of new technology, the
Analytical Balance is finding its way from
Pharmaceutical analytical laboratories into
the Pharmacy setting. Due to convenience,
precision and accuracy, as well as a
sensitivity of a digital readout of 0.1 mg, most
pharmacies prefer the use of this balance.
1.Papan landasan timbangan
2. Tuas penyangga timbangan
3. Jarum timbangan
4. Penunjuk tegak bedirinya timbangan
5. Skala timbangan
6. Tangan timbangan
7. Mur pengatur keseimbangan
8. Piring timbangan
9. Pengatur tegak berdirinya timbangan
Cara menimbang :
Periksalah semua komponen timbangan, pastikan sudah sesuai
pada tempatnya
Pastikan kedudukan timbangan sudah sejajar/rata (amati penunjuk
tegaknya timbangan, harus lurus sejajar) jika belum atur dengan
memutar/menyesuaikan pengaturnya)
Putar/tuas penyangga timbangan, timbangan akan terangkat ,
amati keseimbangan piring.
Jika belum seimbang atur dengan memutar mur pengatur
keseimbangan sampai terjadi keseimbangan.
Setelah seimbang letakkan kertas perkamen diatas kedua piring,
angkat tuas untuk melihat apakah timbangan sudah seimbang
Jika sudah siap penimbangan bisa dilakukan
4) Weights
Weights used for the Class A Prescription Balance and other balances are made of brass or polished
metal and must be maintained and handled properly. These sets usually contain cylindrical weights
ranging from 1 to 50 gms and fractional weights of 10 to 500 mg. Once yearly the weights should be
calibrated to ensure accuracy.
b. Spatula
Spatulas are used to transfer solid
ingredients such as powders,
ointments, creams to weighing
pans. They are also used to mix
ingredients together into
homogenous mixtures. Spatulas are
available in stainless steel, plastic
and hard rubber, the type of spatula
to use is dependent on what is
being transferred or mixed.
 Mortar and Pestle
The mortar and pestle is used
to grind particles into fine
powders (trituration). The
incorporation of a liquid
(levigation) can further reduce
particle size. Mortar and Pestles
are made of Glass, Porcelain,
Wedgwood or Marble. Glass is
preferable for mixing liquids
and semisoft dosage forms.
d. Graduates
Graduates are used in the measurement of liquids. Most graduates are marked
TD which means, to deliver. This marking indicates that the measurement of
this graduate will compensate for the excess liquid that adheres to the surface of
the graduate after emptying.
1) Conical Graduate
The Conical graduate has a wide mouth and wide base to allow the stirring of liquids with
a glass stirring rod. As the diameter of the graduate increases, the accuracy decreases.
The conical graduate varies in size from 10ml to 4000ml.
2) Cylindrical Graduates The Cylindrical graduate is uniform from top to bottom and is the
most accurate graduate for the measurement of liquids.
e. Ointment Slabs
Along with the mortar, pestle and spatula, the Ointment Slab is mainstay in the
Pharmacy setting. Ointment slabs provide a clean, hard surface for the mixing of
compounds. Most ointment slabs are ground glass plates, that provide a non-
absorbable surface area. For multiple compounding, many pharmacies purchase
Parchment Papers that serve the same purpose when placed over an ointment
slab, but are easily disposed of after use without the necessary cleaning involved
between mixtures.
f. Capsule Machine
The Jaansun Capsule Machine provides pharmacists with a more time efficient
and accurate method of making capsules. It is designed to avoid labor-intensive
hand punching, and accommodates oil-filled capsules, with the capacity to make
up to 300 capsules at a time.
g. Rapid Dissolve Tablet (RDT) Mold
Active ingredients are mixed with the RDT base, sweetened and flavored, then
pressed into the mold and baked.
h. Electronic Mortar and Pestle
The electronic mortar and pestle
provides pharmacists with the
modern way to compound
creams, gels and ointments.
i. Ointment Mill
The ointment mill reduces the
particle size of powders, crystals,
and creams, resulting in a
smooth and elegant finished
compound.
j. Tube Sealer
The tube sealer provides an
efficient way to seal plastic
tubes, bags, suppository shells
and sleeves.
 Pillus Mold
use for to cut and round the pills
Suppositoria Mold Tablet Mold
Manufacturing
Manufacturing As defined in the NABP Model State Pharmacy Act: The
production, preparation, conversion, or processing of a drug or deviceand
includes any packaging, or repackaging of the substance(s) or labeling or relabeling
of its container, and the promotion and marketing of such Drugs or Devices.
Manufacturing also includes the preparation and promotion of commercially
available products from bulk compounds for resale by the pharmacies,
practitioners, or other persons.
Compounding vs. Manufacturing
Manufacturing
No specific patient in mind when drug is produced
Has prescribers matching patients to the product available
Economic considerations limit choices in drug dosages and dosage forms
Compounding
Making the formula match the patients needs
Administering the drug to the site of action in the most effective dosage form available
SYNONYMS OF
DRUG
Synonyms of Drug
The official name - the others name
contains the official name and its equivalents with other
name (other names: a generic name which not officially
include common names, abbreviations and trade names).
Other names Index - trade name
contains other names and its equivalents with the trade
name.

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Synonyms of Drug (The official name - the others name)

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Synonyms of Drug (The official name - the others name)

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Synonyms of Drug (The official name - the others name)

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Synonyms of Drug (Other names Index - trade name)

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Synonyms of Drug (Other names Index - trade name)

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Synonyms of Drug (Other names Index - trade name)

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SPESIALIT DRUGS
Spesialite drug
Definition
Spesialite Drugs: is studying medicine based
functions include the generic name, trade name,
alone or in combination appropriate dosage form and
strength of the ingredients.
Spesialite drug (names and types
of drug)
Drugs are named based on:
1. The content of chemical substances (chemical
name)
2. Generic name
3. Name of trademark
Generic drugs : is a drug with the official name specified in the
Indonesian Pharmacopoeia for nutritious substances contains.

Patent drugs : is a drug with a trademarked name and use the

name that is owned by the drug manufacturer.
1. Pencahar / Laxantia
meliputi : Rhei, Aloe, Sennae, Bisacodyl, Dantron, Oleum Ricini,Kalomel, MgSO4,
Na2HPO4, Agar, CMC, Tylose.2.

2. Anti Spasmodik
meliputi : Alkaloid Belladonae, Atropin Sulfas, Hiosinamid ButhylBromid, Propantelin
Bromida, Cisaprid, Mebeverin HCL.3.

3. Analgetik non Narkotik

meliputi : Acidum Acetylosalicylicum atau Asetosal darigolongan Salisilat,
Parasetamol atau Acetaminophenum dari golongan Para Amino Fenol,Metampiron
dan Fenilbutazon dari golongan Pirazolon, Asam Mefenamat dari
golonganAntranilat.4.

4. Anti Emetika
meliputi : Domperidon, Granisetron, Hiosin, Klorpromazin,Metoklopramid,
Ondansetron, Perfenazin, Proklorferazin, Trifluoferazin, Tropisetron,Dimenhidrinat,
Prometazin, Sinarizin.
5. Anti Epilepsi
meliputi : Difenil Hidantoin, Karbamazepin, Phenobarbital, Diazepam,Asam
Valproat.6.

6. Anti Depresan
meliputi : Amitriptilin HCl, Klomipramin HCl, Imipramin HCl,Nortriptilin,
Meprotilin HCl, Mianserin HCL, Trazodon HCl, Moklobemid,
Fluoksetin,Fluvoksamin, Paroksetin, Sertralin, Amineptin.7.

7. Anastesi Lokal
meliputi : Lidokain HCL, Bupivakain HCl, Prilokain HCl, Prokain HCl,Tetrakain,
Benzokain.
8. Kardiaka
meliputi : Digitalis Folium, Digoksin, Digitoksin, Quabain,
Proscillaridin,Nitrogliserin, Dipiridamol, Nifedipin, Diltiazem,
Verapamil, Propanolol, Acebutolol,Timolol, Kinidin, Amiodaron,
Sotalol.9.

7. Hemostatik Sistemik
meliputi : Karbozokrom, Asam Traneksamat, Ethamsylate,
AntiHemophylic Factor II, VII, VIII, IX, X, Phytonadion, Menadion

8. Antibiotik
meliputi : Penisilin, Rifampisin, Sefadroksil, Kloramfenikol dll,
CLASSIFICATION OF
DRUGS
 BASED ON
GOVERNMENT
RULE
The Controlled Substance Act
The government maintains five schedules
of classifications for controlled substances
Controlled substances are placed in these
schedules according to:
Potential for abuse
Potential for dependence
Medical value
bsapp.com
Schedule I
Substances in this schedule have no currently accepted
medical use in the United States, a lack of accepted safety for
use under medical supervision, and a high potential for abuse.
Some examples of substances listed in Schedule I are:
heroin, lysergic acid diethylamide (LSD), marijuana (cannabis),
peyote, methaqualone, and 3,4-
methylenedioxymethamphetamine (Ecstasy).

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Schedule II
Substances in this schedule have a high potential for abuse which may
lead to severe psychological or physical dependence.
Examples of Schedule II narcotics include: hydromorphone (Dilaudid),
methadone (Dolophine), meperidine (Demerol), oxycodone (OxyContin,
Percocet), and fentanyl (Sublimaze, Duragesic). Other Schedule II narcotics
include: morphine, opium, and codeine.
Examples of Schedule IIN stimulants include: amphetamine (Dexedrine,
Adderall), methamphetamine (Desoxyn), and methylphenidate (Ritalin).
Other Schedule II substances include: amobarbital, glutethimide, and
pentobarbital.

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Schedule III
Substances in this schedule have a potential for abuse less than
substances in Schedules I or II and abuse may lead to moderate or low
physical dependence or high psychological dependence.
Examples of Schedule III narcotics include: combination products
containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin),
products containing not more than 90 milligrams of codeine per dosage unit
(Tylenol with Codeine), and buprenorphine (Suboxone).
Examples of Schedule IIIN non-narcotics include: benzphetamine
(Didrex), phendimetrazine, ketamine, and anabolic steroids such as Depo-
Testosterone.

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Schedule IV
Substances in this schedule have a low potential for abuse
relative to substances in Schedule III.
Examples of Schedule IV substances include: alprazolam
(Xanax), carisoprodol (Soma), clonazepam (Klonopin),
clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan),
midazolam (Versed), temazepam (Restoril), and triazolam
(Halcion).

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Schedule V
Substances in this schedule have a low potential for abuse
relative to substances listed in Schedule IV and consist primarily
of preparations containing limited quantities of certain
narcotics.
Examples of Schedule V substances include: cough
preparations containing not more than 200 milligrams of
codeine per 100 milliliters or per 100 grams (Robitussin AC,
Phenergan with Codeine), and ezogabine.

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BASED ON FDA
Category A

Adequate and well-controlled studies have failed to

demonstrate a risk to the fetus in the first trimester of
pregnancy (and there is no evidence of risk in later trimesters).
Example drugs or substances: levothyroxine, folic acid,
liothyronine

MIMS Pte Ltd. 2015

Category B

Animal reproduction studies have failed to

demonstrate a risk to the fetus and there are no
adequate and well-controlled studies in pregnant
women. Example drugs: metformin,
hydrochlorothiazide, cyclobenzaprine, amoxicillin,
pantoprazole

MIMS Pte Ltd. 2015

Category C

Animal reproduction studies have shown an adverse

effect on the fetus and there are no adequate and well-
controlled studies in humans, but potential benefits
may warrant use of the drug in pregnant women
despite potential risks. Example drugs: tramadol,
gabapentin, amlodipine, trazodone

MIMS Pte Ltd. 2015

Category D

There is positive evidence of human fetal risk based

on adverse reaction data from investigational or
marketing experience or studies in humans, but
potential benefits may warrant use of the drug in
pregnant women despite potential risks. Example
drugs: lisinopril, alprazolam, losartan, clonazepam,
lorazepam

MIMS Pte Ltd. 2015

Category X

Studies in animals or humans have demonstrated

fetal abnormalities and/or there is positive evidence of
human fetal risk based on adverse reaction data from
investigational or marketing experience, and the risks
involved in use of the drug in pregnant women clearly
outweigh potential benefits. Example drugs:
atorvastatin, simvastatin, warfarin, methotrexate,
finasteride

MIMS Pte Ltd. 2015

The A, B, C, D and X risk categories, in use
since 1979, are now replaced with narrative
sections and subsections to include:
Pregnancy (includes Labor and Delivery):
Pregnancy Exposure Registry
Risk Summary
Clinical Considerations
Data
Lactation (includes Nursing Mothers)
Risk Summary
Clinical Considerations
Data
Females and Males of Reproductive Potential
Pregnancy Testing
Contraception
Infertility
https://www.drugs.com
Pregnancy
The Pregnancy subsection will provide information about dosing and
potential risks to the developing fetus and registry information that collects
and maintains data on how pregnant women are affected when they use the
drug or biological product. Information in drug labeling about the existence
of any pregnancy registries has been previously recommended but not
required until now. Contact information for the registries will also be
included, and pregnant women are encouraged to enroll to help provide data
on the effects of drug use or biologics in pregnancy.
If information for the subsections of Pregnancy Exposure Registry,
Clinical Considerations, and Data is not available, these subsections will be
excluded. The Risk Summary subheadings are always required, even if no
data is available
https://www.drugs.com
Lactation
The Lactation subsection will replace the Nursing Mothers
subsection of the old label. Information will include drugs that
should not be used during breastfeeding, known human or
animal data regarding active metabolites in milk, as well as
clinical effects on the infant. Other information may include
pharmacokinetic data like metabolism or excretion, a risk and
benefit section, as well as timing of breastfeeding to minimize
infant exposure

https://www.drugs.com
Females and Males of
Reproductive Potential
In the subsection entitled Females and Males of
Reproductive Potential, relevant information on pregnancy
testing or birth control before, during or after drug therapy,
and a medications effect on fertility or pregnancy loss will be
provided when available.

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BASED ON ROUTE
OF
ADMINISTRATION
1. Enteral Route:

Enteral route is through the alimentary canal. It might

be:
Oral
Sublingual
Per rectum

Verma, P. et.,al. 2010

 a. Oral Route:
Oral route is the most common route of drug administration. It is mostly used for the neutral drugs.
It may be in the form of tablets, capsules, syrup, emulsions or powders.
Advantages:
It is convenient
It is the cheapest available route
It is easy to use
It is safe and acceptable.
Disadvantages:
Less amount of drug reaches the target tissue.
Some of the drug is destroyed by gastric juices e.g. adrenaline, insulin, oxytocin
Absorption has to take place which is slow, so is not preferred during emergency.
It might cause gastric irritation
It might be objectionable in taste.
It might cause discoloration of teeth e.g. iron causes staining, tetracyclines below 14 cause brown
discoloration so are not advisable during pregnancy.
Verma, P. et.,al. 2010
 b. Sublingual Route:
Sublingual route involves tablets placed under the tongue or between cheeks or Gingiva.
The drug should be lipid soluble and small.
Advantages:
Rapid absorption takes place.
Drug is dissolved easily
Drug enters the blood directly
Less first pass effect.
Spitting out of the drug removes its effect
Disadvantages:
This method is inconvenient.
Irritation of the mucous membrane might occur
Person may swallow the drug
Might be unpleasant in taste. Verma, P. et.,al. 2010
 c. Rectal Route:
Drugs in solid forms such as suppositories or in liquid forms such as enema are given by this
route. This route is mostly used in old patients. Drugs may have local or systemic actions after
absorption.
Advantages:
This route is preferred in unconscious or uncooperative patients.
This route avoids nausea or vomiting
Drug cannot be destroyed by enzymes.
This route is preferred if drug is irritant.
Disadvantages:
This route is generally not acceptable by the patients.
Locally acting drugs include glycerin and Bisacodyl suppository
Systemic acting drugs include Indomethacin (anti inflammatory) and aminophyllin
(bronchodilator)
Retention enema is diagnostic and is used for finding the pathology of lower intestines.
Verma, P. et.,al. 2010
Drugs given by rectal route have 50% first pass metabolism.
 2. Parenteral Route:
Parenteral route includes:
a. Injections:
Intra muscular
Intra venous
Intra-arterial
Intra-cardiac
Intra-thecal
Intraosseous- into bone marrow
Intrapleural
Intraperitoneal
Verma, P. et.,al. 2010
Intra-articular
 4. Topical route:
Drugs may be applied to the external surfaces, the skin and the mucous
membranes. Topical route includes:
a. Enepidermic route
When the drug is applied to the outer skin, it is called enepidermic route of
drug administration. Examples include poultices, plasters, creams and
ointments.
b. Epidermic route (Innunition):
When the drug is rubbed into the skin, it is known as epidermic route.
Examples include different oils.
c. Insufflations:
When drug in finely powdered form is blown into the body cavities or
spaces with special nebulizer, the method is known as insufflations.

Verma, P. et.,al. 2010

d. Instillation
Liquids may be poured into the body by a dropper into the conjunctival
sac, ear, nose and wounds. Solids may also be administered.
e. Irrigation or Douching
This method is used for washing a cavity e.g. urinary bladder, uterus,
vagina and urethra. It is also used for application of antiseptic drugs.
f. Painting/Swabbing
Drugs are simply applied in the form of lotion on cutaneous or mucosal
surfaces of buccal, nasal cavity and other internal organs.
Refferences
[No Author Listed].2013. United Stated Pharmacopeial. USA; The United State Pharmacopeial
Convention
Johnson, Mike , Davis, Karen, Gricat Jeff .2009.The Pharmacy Technicians ; Foundations and
Practices. New Jersey ; Pearson Education
Medina, Joe.2008. Tech Lectures; For the Pharmacy Technician.Denver
MIMS Pte Ltd. 2015. MIMS Petunjuk Konsultasi Edisi 15. Jakarta : PT. Ikhaparmindo Putramas.
Verma, P. et.,al. 2010. Route of Drug Administration. Inernational Journal of Pharmaceutical
Studies and Research. Vol 1. Juli- September 2010.
https://www.drugs.com diakses pada 4 februari 2017
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