inadequate glidant
compressed.
use,
especially
when
oily
or
sticky
ingredients
are
Capping and laminating, while normally associated with poor bonding, may
also occur in systems which are overlubricated with a lubricant such as a
stearate. Attempts have been made to measure the tendency of a powder to cap
and stick when compressed based on theoretical calculations [83]. Rue et al ,
[84] correlated acoustic emissions during tableting of cetaminophen with
lamination and capping events. Acoustic emission analysis demonstrated that
capping occurs within the die wall during the decompression phase and not
during ejection. Capping or lamination observed with curve-face punches can
often be eliminated by switching to flat-faced punches.
Lubricants may be further classified according to their water solubility (as
water-soluble or water-insoluble). The choice of a lubricant may depend in part
on the mode of administration and the type of tablet being produced, the
disintegration and dissolution properties desired, the lubrication and flow
problems and requirements of the formulation, various physical properties of the
granulation or powder system being compressed, drug compatibility
considerations, and cost.
Water-insoluble lubricants in general are more effective than watersoluble
lubricants and are used at a lower concentration level. Table 4 summarizes some
typical insoluble lubricants and their usual use levels.
In general lubricants, whether water-soluble or insoluble, should be 200
mesh or finer and are passed (bolted) through a lOO-mesh screen (nylon cloth)
before addition to the granulation. Since lubricants function by coating (as
noted), their effectiveness is related to their surface area
TERJEMAHAN
Fungsi utama dari pelumas tablet adalah untuk mengurangi gesekan yang
timbul pada antarmuka tablet dan mati dinding selama kompresi dan ejeksi. The
Pelumas juga dapat memiliki sifat antiadherent atau glidant.
Pelumas: Mengurangi gesekan antara granulasi dan mati dinding selama
kompresi dan ejeksi
Antiadherents: Mencegah menempel punch dan, sampai batas lessor, dinding
mati.
Glidants: Meningkatkan karakteristik aliran granulasi tersebut.
Pelumasan dianggap terjadi dengan dua mekanisme. Yang pertama adalah
cairan disebut (atau hidrodinamik) pelumasan karena dua permukaan yang
bergerak dipandang sebagai yang dipisahkan oleh sebuah lapisan terbatas dan
terus menerus pelumas cairan. Sebuah hidrokarbon seperti minyak mineral,
meskipun pelumas yang buruk, adalah contoh dari cairan-jenis pelumas. Minyak
hidrokarbon tidak mudah meminjamkan diri untuk aplikasi untuk tablet granulasi
masalah dan persyaratan formulasi, berbagai sifat fisik dari granulasi atau
sistem bubuk makhluk dikompresi, pertimbangan kompatibilitas obat, dan biaya.
Pelumas larut air secara umum lebih efektif daripada pelumas watersoluble
dan digunakan pada tingkat konsentrasi yang lebih rendah. Tabel 4 merangkum
beberapa pelumas larut khas dan tingkat penggunaan yang biasa mereka. Pada
pelumas umum, apakah air-larut atau tidak larut, harus 200 mesh atau lebih
halus dan diwariskan (kabur) melalui layar Loo-mesh (kain nilon) sebelum Selain
granulasi tersebut. Karena pelumas fungsi dengan lapisan (seperti dicatat),
efektivitas mereka berhubungan dengan luas permukaan mereka
HALAMAN 116
The mechanisms of action of glidants have been hypothesized by various
investigators and include:
1. Dispersion of electrostatic charges on the surface of granulations [92. 93]
2. Distribution of glidant in the granulation [94]
3. Preferential adsorption of gases onto the glidant versus the granulation [94]
4. Minimization of van der Waals forces by separation of the granules [92]
5. Reduction of the friction between particles and surface roughness by the
glidant's adhering to the surface of the granulation [92.93]
Mekanisme aksi dari glidants telah dihipotesiskan oleh berbagai peneliti dan
termasuk:
1. Pendahuluan Penyebaran biaya elektrostatik pada permukaan granulasi [92.
93]
2. Distribusi glidan di granulasi [94]
3. Adsorpsi preferensial gas ke glidant versus granulasi [94]
4. Minimalisasi gaya van der Waals dengan pemisahan butiran [92]
5. Pengurangan gesekan antara partikel dan kekasaran permukaan dengan
berpegang pada glidant untuk permukaan granulasi yang [92.93]
Colorants
Colors are incorporated into tablets generally for one or more of three purposes.
First, colors may be used for identifying similar-looking products within a product
line, or in cases where products of similar appearance exist in the lines of
different manufacturers. This may be of particular importance when product
identification (because of overdosing or poisoning and drug abuse) is a problem.
Second, colors can help minimize the possiblity of mixups during manufacture.
Third, and perhaps least important, is the addition of colorants to tablets for their
aesthetic value or their marketing value.
The difficulties associated with the banning of FD&C Red No. 2 (amaranth),
FD&C Red No.4, and carbon black in 1976 should be a prime example of what
may be the trend of the future. Other colors such as FD&C No. 40 and FD&C
Yellow No. 5 have been questioned recently and will continue to be suspect for
one reason or another. The pharmaceutical manufacturer can maximize the
identification of his products through product shape and size, NDC number, and
use of logos. One should not rely on color as a major means of eliminating inhouse errors but should instead develop adequate general manufacturing
practices to insure that mix-ups do not occur.
Today the formulator may choose a colorant from a decreasing list of colors
designated as D&C and FD&C dyes and lakes, and a small number of acceptable
natural and derived materials approved for use by the U. S. Food and Drug
Administration. Historically, drug manufacturers have, for the most part,
restricted their choice of dyes to the FD&C list. Table 8 summarizes the colors
available at this time.
Dyes are water-soluble materials, whereas lakes are formed by the absorption of
a water-soluble dye on a hydrous oxide (usually aluminum hydroxide), which
results in an insoluble form of the dye.
The photosensitivity of lakes and dyes will be affected by the drug, exeipients,
and methods of manufacture and storage of each product. Ultravioletabsorbing
chemicals have been added to tablets to minimize their photosensitivity. Pastel
shades generally show the least amount of mottling, especially in systems
utilizing water-soluble dyes. Colors near the mid-range of the visible spectrum
(yellow, green) will show less mottling than those at either extreme (blue, red).
PEWARNAAN
Warna yang dimasukkan ke dalam tablet umumnya untuk satu atau lebih dari
tiga tujuan. Pertama, warna dapat digunakan untuk mengidentifikasi produk
serupa tampak dalam lini produk, atau dalam kasus di mana produk dari
penampilan serupa ada di garis produsen yang berbeda. Hal ini mungkin penting
ketika identifikasi produk (karena overdosis atau keracunan dan penyalahgunaan
narkoba) merupakan masalah. Kedua, warna dapat membantu meminimalkan
possiblity mixups selama pembuatan. Ketiga, dan mungkin paling penting,
adalah penambahan pewarna untuk tablet untuk nilai
estetika
atau
nilai pemasaran mereka.
Kesulitan yang berhubungan dengan pelarangan FD & C Red No 2 (bayam), FD &
C Red No.4, dan karbon hitam pada tahun 1976 harus menjadi contoh utama dari
apa yang mungkin menjadi tren masa depan. Warna lain seperti FD & C No 40
dan FD & C Yellow No 5 telah dipertanyakan dan akan terus menjadi tersangka
untuk satu alasan atau yang lain. Para produsen farmasi dapat memaksimalkan
identifikasi produk melalui bentuk produk dan ukuran, jumlah NDC, dan
penggunaan logo. Satu tidak harus bergantung pada warna sebagai sarana